2019-09-26 00:41:58 116 > = MASTER REQUEST (REGULAR) ===================================================================
2019-09-26 00:41:58 133 > Unauthorized access from 31.35.149.224
2019-09-26 00:41:58 134 > - Page generation for '404'
2019-09-26 00:41:59 393 > = MASTER REQUEST (REGULAR) ===================================================================
2019-09-26 00:41:59 393 > Unauthorized access from 31.35.149.224
2019-09-26 00:41:59 394 > - Page generation for '404'
2019-09-26 00:41:59 669 > = MASTER REQUEST (REGULAR) ===================================================================
2019-09-26 00:41:59 669 > Unauthorized access from 31.35.149.224
2019-09-26 00:41:59 670 > - Page generation for '404'
2019-09-26 00:41:59 817 > = MASTER REQUEST (REGULAR) ===================================================================
2019-09-26 00:41:59 817 > Unauthorized access from 31.35.149.224
2019-09-26 00:41:59 817 > - Page generation for '404'
2019-09-26 00:42:00 201 > = MASTER REQUEST (REGULAR) ===================================================================
2019-09-26 00:42:00 202 > Unauthorized access from 31.35.149.224
2019-09-26 00:42:00 202 > - Page generation for '404'
2019-09-26 00:42:08 862 > = MASTER REQUEST (REGULAR) ===================================================================
2019-09-26 00:42:08 863 > - Page generation for 'dashboard'
2019-09-26 00:42:09 574 > = MASTER REQUEST (REGULAR) ===================================================================
2019-09-26 00:42:09 575 > Unauthorized access from 31.35.149.224
2019-09-26 00:42:09 575 > - Page generation for '404'
2019-09-26 00:42:11 431 > = AJAX ACTION REQUEST ============================================================================
2019-09-26 00:42:11 432 > back\coreaxcontroller::getAction(project.setProject)
2019-09-26 00:42:11 467 > = AJAX ACTION REQUEST ============================================================================
2019-09-26 00:42:11 467 > back\coreaxcontroller::getAction(project.getDataListDB)
2019-09-26 00:42:11 479 > back\boresource::getDataList(project as project INNER JOIN __acl as acl ON project.id = acl.id_project, WHERE (acl.id_user = 5))
2019-09-26 00:42:11 741 > = MASTER REQUEST (AJAX) ===================================================================
2019-09-26 00:42:11 742 > - Page generation for 'dashboard'
2019-09-26 00:42:11 884 > = AJAX ACTION REQUEST ============================================================================
2019-09-26 00:42:11 884 > back\coreaxcontroller::getAction(project.getDataListDB)
2019-09-26 00:42:11 886 > back\boresource::getDataList(project as project INNER JOIN __acl as acl ON project.id = acl.id_project, WHERE (acl.id_user = 5))
2019-09-26 00:42:20 923 > = AJAX ACTION REQUEST ============================================================================
2019-09-26 00:42:20 942 > back\coreaxcontroller::getAction(project.setProject)
2019-09-26 00:42:20 943 > back\boresource::get(project, 40)
2019-09-26 00:42:20 988 > = AJAX ACTION REQUEST ============================================================================
2019-09-26 00:42:20 988 > back\coreaxcontroller::getAction(document.getDocuments)
2019-09-26 00:42:21 981 > = MASTER REQUEST (AJAX) ===================================================================
2019-09-26 00:42:21 982 > - Page generation for 'document/documents'
2019-09-26 00:42:22 032 > back\boresource::save(document)
2019-09-26 00:42:22 041 > back\boresource::get(document, 444)
2019-09-26 00:42:22 050 > back\boresource::get(project, 40)
2019-09-26 00:42:22 051 > back\boresource::get(project, 40)
2019-09-26 00:42:22 052 > back\boresource::getList(acl, Array
(
    [id_project] => 40
    [id_user] => 5
)
)
2019-09-26 00:42:22 071 > back\boresource::get(project, 40)
2019-09-26 00:42:22 162 > back\boresource::get(project, 40)
2019-09-26 00:42:22 163 > back\boresource::getList(acl, Array
(
    [id_project] => 40
    [id_user] => 5
)
)
2019-09-26 00:42:22 171 > back\boresource::get(project, 40)
2019-09-26 00:42:22 172 > back\boresource::getList(acl, Array
(
    [id_project] => 40
    [id_user] => 5
)
)
2019-09-26 00:42:22 195 > back\boresource::get(project, 40)
2019-09-26 00:42:22 196 > back\boresource::getList(acl, Array
(
    [id_project] => 40
    [id_user] => 5
)
)
2019-09-26 00:42:22 362 > = AJAX ACTION REQUEST ============================================================================
2019-09-26 00:42:22 362 > back\coreaxcontroller::getAction(document.getDataList)
2019-09-26 00:42:22 365 > back\boresource::getDataList(project AS project INNER JOIN __document AS document ON (document.id_project = project.id), WHERE (project.id = 40 AND (document.validated = 0 OR (document.version = (select max(version) from __document where __document.key_doc = document.key_doc) and validated = 1))))
2019-09-26 00:42:22 368 > = AJAX ACTION REQUEST ============================================================================
2019-09-26 00:42:22 368 > back\coreaxcontroller::getAction(document.setButtons)
2019-09-26 00:42:22 373 > back\boresource::get(project, 40)
2019-09-26 00:42:22 374 > back\boresource::getList(acl, Array
(
    [id_project] => 40
    [id_user] => 5
)
)
2019-09-26 00:43:15 124 > = ACTION REQUEST ============================================================================
2019-09-26 00:43:15 131 > back\coreaxcontroller::getAction(document.getDocumentPDF)
2019-09-26 00:43:15 133 > back\boresource::get(project, 40)
2019-09-26 00:43:15 136 > back\boresource::get(document, 444)
2019-09-26 00:43:15 147 > back\bodocument::getPDF(444)
2019-09-26 00:43:15 147 > back\boresource::get(document, 444)
2019-09-26 00:43:15 148 > back\boresource::get(document, 444)
2019-09-26 00:43:15 149 > back\boresource::get(chapter, 3239)
2019-09-26 00:43:15 150 > back\boresource::get(chapter, 3240)
2019-09-26 00:43:15 152 > back\boresource::get(chapter, 3241)
2019-09-26 00:43:15 153 > back\boresource::get(chapter, 3242)
2019-09-26 00:43:15 155 > back\boresource::get(chapter, 3243)
2019-09-26 00:43:15 156 > back\boresource::get(chapter, 3244)
2019-09-26 00:43:15 158 > back\boresource::get(chapter, 3245)
2019-09-26 00:43:15 159 > back\boresource::get(chapter, 3246)
2019-09-26 00:43:15 160 > back\boresource::get(chapter, 3247)
2019-09-26 00:43:15 162 > back\boresource::get(chapter, 3248)
2019-09-26 00:43:15 163 > back\boresource::get(chapter, 3249)
2019-09-26 00:43:15 164 > back\boresource::get(chapter, 3250)
2019-09-26 00:43:15 165 > back\boresource::get(chapter, 3251)
2019-09-26 00:43:15 167 > back\boresource::get(chapter, 3252)
2019-09-26 00:43:15 168 > back\boresource::get(chapter, 3253)
2019-09-26 00:43:15 169 > back\boresource::get(chapter, 3254)
2019-09-26 00:43:15 170 > back\boresource::get(chapter, 3255)
2019-09-26 00:43:15 171 > back\boresource::get(chapter, 3256)
2019-09-26 00:43:15 172 > back\boresource::get(chapter, 3257)
2019-09-26 00:43:15 174 > back\boresource::get(chapter, 3258)
2019-09-26 00:43:15 175 > back\boresource::get(chapter, 3259)
2019-09-26 00:43:15 176 > back\boresource::get(chapter, 3260)
2019-09-26 00:43:15 177 > back\boresource::get(chapter, 3261)
2019-09-26 00:43:15 179 > back\boresource::get(chapter, 3262)
2019-09-26 00:43:15 180 > back\boresource::get(chapter, 3263)
2019-09-26 00:43:15 181 > back\boresource::get(chapter, 3264)
2019-09-26 00:43:15 183 > back\boresource::get(chapter, 3265)
2019-09-26 00:43:15 184 > back\boresource::get(chapter, 3266)
2019-09-26 00:43:15 186 > back\boresource::get(chapter, 3267)
2019-09-26 00:43:15 187 > back\boresource::get(chapter, 3268)
2019-09-26 00:43:15 188 > back\boresource::get(chapter, 3269)
2019-09-26 00:43:15 189 > back\boresource::get(chapter, 3270)
2019-09-26 00:43:15 191 > back\boresource::get(chapter, 3271)
2019-09-26 00:43:15 192 > back\boresource::get(chapter, 3272)
2019-09-26 00:43:15 193 > back\boresource::get(chapter, 3273)
2019-09-26 00:43:15 194 > back\boresource::get(chapter, 3274)
2019-09-26 00:43:15 196 > back\boresource::get(chapter, 3275)
2019-09-26 00:43:15 197 > back\boresource::get(chapter, 3276)
2019-09-26 00:43:15 198 > back\boresource::get(chapter, 3277)
2019-09-26 00:43:15 199 > back\boresource::get(chapter, 3278)
2019-09-26 00:43:15 201 > back\boresource::get(chapter, 3279)
2019-09-26 00:43:15 202 > back\boresource::get(chapter, 3280)
2019-09-26 00:43:15 203 > back\boresource::get(chapter, 3281)
2019-09-26 00:43:15 204 > back\boresource::get(chapter, 3282)
2019-09-26 00:43:15 206 > back\boresource::get(chapter, 3283)
2019-09-26 00:43:15 207 > back\boresource::get(chapter, 3284)
2019-09-26 00:43:15 208 > back\boresource::get(chapter, 3285)
2019-09-26 00:43:15 209 > back\boresource::get(document, 444)
2019-09-26 00:43:15 210 > back\boresource::get(chapter, 3239)
2019-09-26 00:43:15 211 > back\boresource::get(chapter, 3240)
2019-09-26 00:43:15 212 > back\boresource::get(chapter, 3241)
2019-09-26 00:43:15 213 > back\boresource::get(chapter, 3242)
2019-09-26 00:43:15 214 > back\boresource::get(document, 444)
2019-09-26 00:43:15 214 > back\boresource::get(regulatory, 73)
2019-09-26 00:43:15 215 > back\boresource::get(regulatory, 74)
2019-09-26 00:43:15 216 > back\boresource::get(regulatory, 75)
2019-09-26 00:43:15 217 > back\boresource::get(regulatory, 76)
2019-09-26 00:43:15 218 > back\boresource::get(regulatory, 77)
2019-09-26 00:43:15 218 > back\boresource::get(chapter, 3243)
2019-09-26 00:43:15 219 > back\boresource::get(chapter, 3244)
2019-09-26 00:43:15 220 > back\boresource::get(chapter, 3245)
2019-09-26 00:43:15 221 > back\boresource::get(chapter, 3246)
2019-09-26 00:43:15 222 > back\boresource::get(document, 444)
2019-09-26 00:43:15 223 > back\boresource::get(glossary, 217)
2019-09-26 00:43:15 224 > back\boresource::get(glossary, 218)
2019-09-26 00:43:15 224 > back\boresource::get(glossary, 219)
2019-09-26 00:43:15 225 > back\boresource::get(glossary, 220)
2019-09-26 00:43:15 226 > back\boresource::get(glossary, 221)
2019-09-26 00:43:15 226 > back\boresource::get(glossary, 222)
2019-09-26 00:43:15 227 > back\boresource::get(glossary, 223)
2019-09-26 00:43:15 228 > back\boresource::get(glossary, 224)
2019-09-26 00:43:15 228 > back\boresource::get(glossary, 225)
2019-09-26 00:43:15 229 > back\boresource::get(glossary, 226)
2019-09-26 00:43:15 230 > back\boresource::get(glossary, 227)
2019-09-26 00:43:15 230 > back\boresource::get(glossary, 228)
2019-09-26 00:43:15 231 > back\boresource::get(glossary, 229)
2019-09-26 00:43:15 232 > back\boresource::get(glossary, 230)
2019-09-26 00:43:15 232 > back\boresource::get(glossary, 231)
2019-09-26 00:43:15 233 > back\boresource::get(glossary, 232)
2019-09-26 00:43:15 234 > back\boresource::get(glossary, 233)
2019-09-26 00:43:15 235 > back\boresource::get(glossary, 234)
2019-09-26 00:43:15 235 > back\boresource::get(chapter, 3247)
2019-09-26 00:43:15 236 > back\boresource::get(document, 444)
2019-09-26 00:43:15 237 > back\boresource::get(definition, 36)
2019-09-26 00:43:15 238 > back\boresource::get(definition, 37)
2019-09-26 00:43:15 239 > back\boresource::get(definition, 38)
2019-09-26 00:43:15 240 > back\boresource::get(definition, 39)
2019-09-26 00:43:15 240 > back\boresource::get(definition, 40)
2019-09-26 00:43:15 241 > back\boresource::get(chapter, 3248)
2019-09-26 00:43:15 242 > back\boresource::get(chapter, 3249)
2019-09-26 00:43:15 243 > back\boresource::get(chapter, 3250)
2019-09-26 00:43:15 244 > back\boresource::get(chapter, 3251)
2019-09-26 00:43:15 245 > back\boresource::get(chapter, 3252)
2019-09-26 00:43:15 246 > back\boresource::get(chapter, 3253)
2019-09-26 00:43:15 247 > back\boresource::get(chapter, 3254)
2019-09-26 00:43:15 248 > back\boresource::get(chapter, 3255)
2019-09-26 00:43:15 249 > back\boresource::get(chapter, 3256)
2019-09-26 00:43:15 250 > back\boresource::get(chapter, 3257)
2019-09-26 00:43:15 251 > back\boresource::get(chapter, 3258)
2019-09-26 00:43:15 252 > back\boresource::get(chapter, 3259)
2019-09-26 00:43:15 253 > back\boresource::get(chapter, 3260)
2019-09-26 00:43:15 254 > back\boresource::get(chapter, 3261)
2019-09-26 00:43:15 255 > back\boresource::get(chapter, 3262)
2019-09-26 00:43:15 256 > back\boresource::get(chapter, 3263)
2019-09-26 00:43:15 257 > back\boresource::get(chapter, 3264)
2019-09-26 00:43:15 258 > back\boresource::get(chapter, 3265)
2019-09-26 00:43:15 259 > back\boresource::get(chapter, 3266)
2019-09-26 00:43:15 260 > back\boresource::get(chapter, 3267)
2019-09-26 00:43:15 261 > back\boresource::get(chapter, 3268)
2019-09-26 00:43:15 262 > back\boresource::get(chapter, 3269)
2019-09-26 00:43:15 263 > back\boresource::get(chapter, 3270)
2019-09-26 00:43:15 264 > back\boresource::get(chapter, 3271)
2019-09-26 00:43:15 265 > back\boresource::get(chapter, 3272)
2019-09-26 00:43:15 266 > back\boresource::get(chapter, 3273)
2019-09-26 00:43:15 267 > back\boresource::get(chapter, 3274)
2019-09-26 00:43:15 268 > back\boresource::get(chapter, 3275)
2019-09-26 00:43:15 268 > back\boresource::get(chapter, 3276)
2019-09-26 00:43:15 269 > back\boresource::get(chapter, 3277)
2019-09-26 00:43:15 270 > back\boresource::get(chapter, 3278)
2019-09-26 00:43:15 271 > back\boresource::get(chapter, 3279)
2019-09-26 00:43:15 272 > back\boresource::get(chapter, 3280)
2019-09-26 00:43:15 273 > back\boresource::get(chapter, 3281)
2019-09-26 00:43:15 274 > back\boresource::get(chapter, 3282)
2019-09-26 00:43:15 275 > back\boresource::get(chapter, 3283)
2019-09-26 00:43:15 276 > back\boresource::get(chapter, 3284)
2019-09-26 00:43:15 277 > back\boresource::get(chapter, 3285)
2019-09-26 00:43:15 278 > back\boresource::get(document, 444)
2019-09-26 00:43:15 396 > back\bodocument::generatePDF(<html>
  
  <body>
    <div class="body">
      <style>
        body {
          color: #001028;
          font-family: Arial, sans-serif;
          font-size: 12px;
          margin-bottom:2%;
          margin-top:4%;
        }
        caption{
          text-align:center;
          font-style:italic;
        }
        .texte{
          color: #001028;
          font-family: Arial, sans-serif;
          font-size: 12px;
          margin:10px;
          font-weight:normal;
          text-align:justify;
        }
        header {
          padding: 10px 0;
          margin-bottom: 10px;
        }
        .level-1{
          color: #094592;
          font-weight: bold;
          font-size:13px;
          line-height: 2em;
        }
        .level-2{
          color: #1563c8;
          font-size:13px;
          font-weight:normal;
          text-indent: 2em;
          line-height: 2em;
        }
        .level-3{
          color: #001028;
          font-size:12px;
          font-weight:normal;
          text-indent: 4em;
          line-height: 2em;
        }
        .level-4{
          color: #001028;
          font-size:12px;
          font-weight:normal;
          text-indent: 6em;
          line-height: 2em;
        }
        .title-1{
          text-transform: uppercase;
          font-size : 16px;
          font-weight: bold;
          color: #1563af;
        }
        hr{
          background-color: #1563af;
          height: 1px;
          border: none;
        }
        .title-2{
          font-size:14px;
          color: #1563af;
          font-weight:bold;
          margin-left:15px;
        }
        .title-3{
          color: #001028;
          font-weight:bold;
          margin-left:30px;
        }
        .li_spec{
          list-style:none;
        }
        .breakafter { 
          page-break-after: always; 
        }
        .pageInside{
          page-break-inside:avoid;
        }
        .normal_cell{
          border: 1px solid #001028;
          vertical-align:bottom;
          height: 25px;
          text-align: justify;
          padding: 10px;
        }
        .normal_table{
          border-collapse:collapse;
        }
        .bold{
          font-weight:bold;
        }
        .justify{
          text-align:justify;
        }
        .center{
          text-align:center;
        }
        .centering{
          margin-left:auto;
          margin-right:auto;
        }
        .first_lign{
          font-weight: bold;
          color: white;
          background-color: #1163c7;
        }
        .normal{
          background-color: white;
        }
        .first-cell{
          font-weight:bold;
          border: 1px solid #001028;
          vertical-align:middle;
          padding:10px;
        }
        .basic_cell{
          border: 1px solid #001028;
          padding: 10px;
          vertical-align:middle;
        }
        .cell_30{
          width:30%;
        }
        .cell_70{
          width:70%;
        }
        .cell_50{
          width: 50%;
        }
        .big-cell{
          height: 50px;
          vertical-align:bottom;
          text-align:center;
          vertical-align:middle;
        }
        .all_page{
          width:100%;
        }
        .gray{
          background-color : #e9ebed;
        }
        .big_title{
          font-size:25px;
          font-weight:bold;
          color: #094592;
        }
        .logo{
          width:50%;
        }
        .img_logo{
          margin-left: 250px;
          margin-right: auto;
        }
        .cover{
          color: #1163c7;
          font-size: 30px;
          font-weight:bold;
          text-transform: uppercase;
          text-align:center;
        }
        .cover_title{
          color: #1163c7;
          font-size: 30px;
          text-align:center;
        }
        .first_gray{
          background-color : #858585;
          text-align:center;
          color:white;
          font-weight:bold;
          font-size:10px;
          padding:10px;
          border: 1px solid #828588;
        }
        .small{
          font-size:10px;
          padding:5px;
          border: 1px solid #828588;
        }
        .light_gray{
          color:white;
          text-align:justify;
          font-size:8px;
          padding:2px;
          font-style:italic;
          background-color:#BCBCBC;
          border: 1px solid #828588;
        }
        .bottom{
          bottom:20%;
          position:absolute;
        }
        .category{
          font-weight:bold;
          text-align:center;
          background-color:#e9ebedbe;
          border: 1px solid #001028;
          padding:10px;
        }
        .normal_gray{
          background-color:#e9ebedbe;
          text-align:center;
          border: 1px solid #001028;
        }
        .cell_60{
          width:60%;
        }
        img{
          max-width: 500px;
          height: auto;
        }
        html{margin:40px 50px}
      </style>
      <br/><br/><br/><br/><br/><br/><br/><br/><br/><br/><br/>
      <div class="cover">Digitalis</div>
      <div class="cover_title">Validation Plan</div>
      <table class="all_page normal_table breakafter bottom">
        <tr ><td class="first_gray center">Cerebellis</td><td class="first_gray center">Digitalis</td></tr>
        <tr><td></td><td class="small cell_50"><b>Reference : </b>Digitalis_VP</td></tr>
        <tr><td></td><td class="small"><b>Date : </b>2019-09-26</td></tr>
        <tr><td></td><td class="small"><b>Version : </b>1</td></tr>
        <tr><td></td><td class="small"><b>Status : </b>Signed</td></tr>
        <tr><td></td><td class="small"><b>Author : </b>Euzen Marie</td></tr>
        <tr><td></td><td class="light_gray">This document is confidential and may not be released without the prior consent of Cerebellis</td></tr>
      </table>
      <div class="center big_title">Versions</div>
      <br/>
      <div> <table class='pageInside centering normal_table all_page'><tr><td class='first-cell center cell_15 first_lign'>Version</td><td class='first-cell cell_15 center first_lign'>Date</td><td class='first-cell center cell_70 first_lign'>Description</td></tr><tr><td class='normal_cell center'>1</td><td class='normal_cell center gray'>2019-08-30 09:46:38</td><td class='normal_cell justify'>first release</td></tr></table></div>
      <br/>
      <br/>
      <div class="center big_title">Signatures</div>
      <br>
      <div class="breakafter"> 
        <table class='pageInside all_page normal_table centering'>
          <tr class='first_lign center'><td class='normal'></td><td class='basic_cell'>Redactor</td><td class='basic_cell'>Relector</td><td class='basic_cell'>Relector</td><td class='basic_cell'>Approvor</td></tr><tr class='center'><td class='first-cell'>Name</td><td class='basic_cell gray'>Euzen Marie</td><td class='basic_cell'>Pucheu Marion </td><td class='basic_cell gray'>Noyon Laurent</td><td class='basic_cell'>Perraudin Thomas</td></tr><tr class='center'><td class='first-cell'>Role</td><td class='basic_cell gray'>Computer System Validation Specialist</td><td class='basic_cell'>Process Owner</td><td class='basic_cell gray'>Technical Unit</td><td class='basic_cell'>Business Responsible</td></tr><tr class='center'><td class='first-cell'>Date</td><td class='basic_cell gray'></td><td class='basic_cell'></td><td class='basic_cell gray'></td><td class='basic_cell'></td></tr><tr class='center ' ><td class='first-cell big-cell'>Signature</td><td class='basic_cell big-cell gray'></td><td class='basic_cell big-cell'></td><td class='basic_cell big-cell gray'></td><td class='basic_cell big-cell'></td></tr><tr style='text-align:left;'><td class='first-cell'>Meaning of Signature</td><td class='basic_cell gray'>I confirm that the execution of the plan will produce a system compliant with applicable procedures and regulations.</td><td class='basic_cell'>I confirm that the validation plan includes all activities and deliverables suitable for managing quality on this project. 
I will execute this plan according to my responsibility, delivering a system fit for supporting business processes.
</td><td class='basic_cell gray'>I confirm that the validation plan includes all activities and deliverables suitable for managing quality on this project.  
I will execute this plan according to my responsibility, delivering a system fit for technical processes.
</td><td class='basic_cell'>I confirm that the validation plan includes all activities and deliverables suitable for managing quality on this project. 
I confirm that the execution of the plan will produce a system compliant with applicable procedures and regulations.  
</td></tr>
        </table>
      </div>
      <div class="center big_title">Table of contents</div>
      <br/><br/><br/>
      <div class="breakafter"><li class='level-1 li_spec'>1.   Introduction<li class='level-2 li_spec'>1.1.   Purpose<br/></li><li class='level-2 li_spec'>1.2.   Scope<li class='level-3 li_spec'>1.2.1.   Regulatory Scope<br/></li><li class='level-3 li_spec'>1.2.2.   System scope & limitations<br/></li><br/></li><li class='level-2 li_spec'>1.3.   System Overview<br/></li><br/></li><li class='level-1 li_spec'>2.   Acronyms & Definitions<li class='level-2 li_spec'>2.1.   Acronyms<br/></li><li class='level-2 li_spec'>2.2.   Definitions<br/></li><br/></li><li class='level-1 li_spec'>3.   System Definition<li class='level-2 li_spec'>3.1.   System Description<br/></li><li class='level-2 li_spec'>3.2.   Hardware architecture and location<br/></li><li class='level-2 li_spec'>3.3.   System responsibilities<br/></li><li class='level-2 li_spec'>3.4.   System Responsibilities table<br/></li><li class='level-2 li_spec'>3.5.   System environments<br/></li><li class='level-2 li_spec'>3.6.   Configuration Management<li class='level-3 li_spec'>3.6.1.   Tools<br/></li><li class='level-3 li_spec'>3.6.2.   Version Numbering<br/></li><li class='level-3 li_spec'>3.6.3.   Process<br/></li><br/></li><br/></li><li class='level-1 li_spec'>4.   Risk Management Approach<li class='level-2 li_spec'>4.1.   Risk Assessment<br/></li><li class='level-2 li_spec'>4.2.   Functional Risk Assessment<br/></li><br/></li><li class='level-1 li_spec'>5.   Validation Strategy<li class='level-2 li_spec'>5.1.   Traceability<br/></li><li class='level-2 li_spec'>5.2.   Analysis and Design<br/></li><li class='level-2 li_spec'>5.3.   Installation Qualification<li class='level-3 li_spec'>5.3.1.   Steps<br/></li><li class='level-3 li_spec'>5.3.2.   Documentation and Records<br/></li><br/></li><li class='level-2 li_spec'>5.4.   Operational Qualification<li class='level-3 li_spec'>5.4.1.   Steps<br/></li><li class='level-3 li_spec'>5.4.2.   Documentation and Records<br/></li><br/></li><li class='level-2 li_spec'>5.5.   Deviations Management<li class='level-3 li_spec'>5.5.1.   Deviations from requirements and specifications (Incidents)<br/></li><li class='level-3 li_spec'>5.5.2.   Deviations from the validation plan<br/></li><br/></li><br/></li><li class='level-1 li_spec'>6.   Validation Reports<li class='level-2 li_spec'>6.1.   Qualification reports<br/></li><li class='level-2 li_spec'>6.2.   Phases sequence<br/></li><li class='level-2 li_spec'>6.3.   Conditional Acceptance<br/></li><li class='level-2 li_spec'>6.4.   Final Acceptance<br/></li><li class='level-2 li_spec'>6.5.   Validation Report<br/></li><li class='level-2 li_spec'>6.6.   Validation Report Table<br/></li><li class='level-2 li_spec'>6.7.   Validation Report Follow<br/></li><br/></li><li class='level-1 li_spec'>7.   Delivrable Matrix<li class='level-2 li_spec'>7.1.   Roles and Responsibilities<br/></li><li class='level-2 li_spec'>7.2.   Delivrables<br/></li><li class='level-2 li_spec'>7.3.   Delivrables Table<br/></li><br/></li><li class='level-1 li_spec'>8.   References<br/></li></div>
      <div class="breakafter"><div class='pageInside'><li class='title-1 li_spec'>1.   Introduction<hr><br/></div><div class='pageInside'><li class='title-2 li_spec'>1.1.   Purpose<br/></div><div class='texte'><p class="MsoNormal"><span lang="EN-US">The purpose
of this Validation Plan (VP) is to define the strategy, activities,
deliverables and responsibilities to be performed for the validation of the
DIGITALIS system.<o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-US">Its goal is
to set the principles to:<o:p></o:p></span></p><ul style="margin-top:0cm" type="disc">
 <li class="MsoNormal"><span lang="EN-US">Bring evidences that involved processes
     are compliant with quality and regulatory requirements,<o:p></o:p></span></li>
 <li class="MsoNormal"><span lang="EN-US">Ensure the safety and integrity of
     critical data.<o:p></o:p></span></li>
</ul><p class="MsoNormal"><span lang="EN-US">The
objective of validation is to demonstrate with a high level of confidence that
the system DIGITALIS will operate correctly when used, in terms of the scope of
use described in user requirements specifications and detailed functional
specifications of the system. <o:p></o:p></span></p><p>







</p><p class="MsoNormal"><span lang="EN-US">The results
of the validation will be described in a Validation Report.<o:p></o:p></span></p><br/></div><br/></li><div class='pageInside'><li class='title-2 li_spec'>1.2.   Scope<br/></div><div class='pageInside'><li class='title-3 li_spec'>1.2.1.   Regulatory Scope<br/></div><div class='texte'><table class="centering normal_table all_page"><tr><td class="first-cell cell_50 center first_lign">Regulation</td><td class=" first-cell cell_50 gray center">Detailed Description</td></tr><tr><td class='basic_cell gray bold'>CE Regulation and European directive</td><td class='normal_cell'>EudraLex Volume 4 – Annex 11 « Computerised Systems » and Annex 15 « Qualification and Validation »</td></tr><tr><td class='basic_cell gray bold'>ICH Topic E6</td><td class='normal_cell'>International Conference on Harmonization - Guideline for Good Clinical Practices</td></tr><tr><td class='basic_cell gray bold'>FDA 21 CFR (Code of Federal Regulations) Part 11</td><td class='normal_cell'>Electronic Records, Electronic Signatures – Final Rule</td></tr><tr><td class='basic_cell gray bold'>GAMP5</td><td class='normal_cell'>A Risk-based Approach to Compliant GxP Computerised Systems</td></tr><tr><td class='basic_cell gray bold'>PIC/S Guidance (PI011)</td><td class='normal_cell'>Good Practices for Computerised Systems in Regulated « GXP » Environments</td></tr></table><br/></div><br/></li><div class='pageInside'><li class='title-3 li_spec'>1.2.2.   System scope & limitations<br/></div><div class='texte'><p class="MsoNormal"><span lang="EN-US">This
validation procedure embraces all computerized and automatized systems used by
process in the scope of Digitalis, including user interfaces and automated
processes for data collection, data management, user accounts management and
system administration.<o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-US">The Digitalis
application of the system is composed of a core application, an intermediate
programming layer for specific adaptations, and a configuration depending on
the end user requirements. The intermediate programming layer and configuration
are not included in the scope of validation.<o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-US">This is
described in the user requirements specifications and in the detailed
functional specifications documents.<o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-US">It doesn’t
include:<o:p></o:p></span></p><p class="MsoListParagraphCxSpFirst" align="left" style="margin: 0cm 0cm 0.0001pt 36pt; text-indent: -18pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US">·<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">Text
or spreadsheet documents without macros,<o:p></o:p></span></p><p class="MsoListParagraphCxSpMiddle" align="left" style="margin: 0cm 0cm 0.0001pt 36pt; text-indent: -18pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US">·<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">Software
used in processes outside scope: accounting, legal, interfaced software…<o:p></o:p></span></p><p>











</p><p class="MsoListParagraphCxSpLast" align="left" style="margin: 0cm 0cm 0.0001pt 36pt; text-indent: -18pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US">·<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US" style="background:yellow;
mso-highlight:yellow;mso-ansi-language:EN-US">The IT infrastructure managed
through the xxx procedure (your procedure).</span><span lang="EN-US"> <o:p></o:p></span></p><br/></div><br/></li><br/></li><div class='pageInside'><li class='title-2 li_spec'>1.3.   System Overview<br/></div><div class='texte'><p class="MsoNormal"><a name="_Toc518555818"></a><a name="_Toc373496976"></a><a name="_Toc163235449"><span lang="EN-US">The eCRF solution by Cerebellis is composed of Digitalis and ODM
Designer:<o:p></o:p></span></a></p><p class="MsoListParagraphCxSpFirst" style="margin-left:18.0pt;mso-add-space:
auto;text-indent:-18.0pt;mso-list:l0 level1 lfo1;tab-stops:list 18.0pt"><!--[if !supportLists]--><span lang="EN-US">1.<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">Digitalis
is the interface to manage the subjects and enter the data,<o:p></o:p></span></p><p>



</p><p class="MsoListParagraphCxSpLast" style="margin-left:18.0pt;mso-add-space:auto;
text-indent:-18.0pt;mso-list:l0 level1 lfo1;tab-stops:list 18.0pt"><!--[if !supportLists]--><span lang="EN-US">2.<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">ODM
Designer is like a back office where it is possible to design a study and its
protocol (study events, forms, items …)</span><span lang="EN-US"><o:p></o:p></span></p><br/></div><br/></li><br/></li><div class='pageInside'><li class='title-1 li_spec'>2.   Acronyms & Definitions<hr><br/></div><div class='texte'><p class="MsoNormal"><span lang="EN-US">Digitalis
is an EDC system, a computerized system designed for the collection of clinical
data in electronic format<o:p></o:p></span></p><p>

</p><p class="MsoNormal"><span lang="EN-US">This
document describes the different validation steps related to Digitalis® as an
EDC system that complies with 21 CFR 11, ICH GCP guidelines and is consistent
with FDA guidance on electronic systems used in clinical trials and abide CDISC
standards.<o:p></o:p></span></p><br/></div><div class='pageInside'><li class='title-2 li_spec'>2.1.   Acronyms<br/></div><div class='texte'><table class="centering normal_table all_page"><tr><td class="first-cell first_lign cell_10">Abbreviation</td><td class="first-cell cell_70 gray center">Description</td></tr><tr><td class='basic_cell gray bold'>CAPA</td><td class='normal_cell'>Corrective Action and Preventive Action</td></tr><tr><td class='basic_cell gray bold'>CFR</td><td class='normal_cell'>Code of Federal Regulation</td></tr><tr><td class='basic_cell gray bold'>CSV</td><td class='normal_cell'>Computer System Validation</td></tr><tr><td class='basic_cell gray bold'>ECRF</td><td class='normal_cell'>electronic Case Report Form</td></tr><tr><td class='basic_cell gray bold'>EDC</td><td class='normal_cell'>Electronic Data Capture</td></tr><tr><td class='basic_cell gray bold'>ICH</td><td class='normal_cell'>International Conference on Harmonisation</td></tr><tr><td class='basic_cell gray bold'>FDA</td><td class='normal_cell'>Food and Drugs Administration</td></tr><tr><td class='basic_cell gray bold'>FS</td><td class='normal_cell'>Functional Specifications</td></tr><tr><td class='basic_cell gray bold'>GAMP</td><td class='normal_cell'>Good Automated Manufacturing Practices</td></tr><tr><td class='basic_cell gray bold'>IQ</td><td class='normal_cell'>Installation Qualification</td></tr><tr><td class='basic_cell gray bold'>IT</td><td class='normal_cell'>Information Technology</td></tr><tr><td class='basic_cell gray bold'>ODM</td><td class='normal_cell'>Operational Data Model</td></tr><tr><td class='basic_cell gray bold'>OQ</td><td class='normal_cell'>Operational Qualification</td></tr><tr><td class='basic_cell gray bold'>PQ</td><td class='normal_cell'>Performance Qualification</td></tr><tr><td class='basic_cell gray bold'>QA</td><td class='normal_cell'>Quality Assurance</td></tr><tr><td class='basic_cell gray bold'>SOP</td><td class='normal_cell'>Standard Operating Procedure</td></tr><tr><td class='basic_cell gray bold'>URS</td><td class='normal_cell'>User Requirements Specifications</td></tr><tr><td class='basic_cell gray bold'>VP</td><td class='normal_cell'>Validation Plan</td></tr></table><br/></div><br/></li><div class='pageInside'><li class='title-2 li_spec'>2.2.   Definitions<br/></div><div class='texte'><table class="centering normal_table all_page"><tr><td class="first-cell first_lign cell_10">Term</td><td class="first-cell cell_70 gray center">Definition</td></tr><tr><td class='basic_cell gray bold'>CAPA</td><td class='normal_cell'>Set of actions to take in documentation, procedures, or systems to rectify and eliminate non-conformities.</td></tr><tr><td class='basic_cell gray bold'>ECRF</td><td class='normal_cell'>Electronic forms dedicated to clinical data collection.</td></tr><tr><td class='basic_cell gray bold'>EDC</td><td class='normal_cell'>Computerized system designed for the collection of clinical data in electronic format.</td></tr><tr><td class='basic_cell gray bold'>ODM</td><td class='normal_cell'>The CDISC Operational Data Model (ODM) is designed to facilitate the regulatory-compliant acquisition, archive and interchange of metadata and data for clinical research studies. ODM is a vendor-neutral, platform-independent format for interchange and archive of clinical study data.</td></tr><tr><td class='basic_cell gray bold'>SOP</td><td class='normal_cell'>Set of detailed, written instructions on how to perform a routine business activity with efficiency, quality output and uniformity of performance, explain the process being described, and help comply with industry regulations.</td></tr></table><br/></div><br/></li><br/></li><div class='pageInside'><li class='title-1 li_spec'>3.   System Definition<hr><br/></div><div class='pageInside'><li class='title-2 li_spec'>3.1.   System Description<br/></div><div class='texte'><p class="MsoNormal"><span lang="EN-US">The eCRF
solution by Cerebellis is composed of Digitalis and ODM Designer:<o:p></o:p></span></p><p class="MsoListParagraphCxSpFirst" style="margin-left:18.0pt;mso-add-space:
auto;text-indent:-18.0pt;mso-list:l1 level1 lfo2;tab-stops:list 18.0pt"><!--[if !supportLists]--><span lang="EN-US">1.<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">Digitalis
is the interface to manage the subjects and enter the data,<o:p></o:p></span></p><p class="MsoListParagraphCxSpMiddle" style="margin-left:18.0pt;mso-add-space:
auto;text-indent:-18.0pt;mso-list:l1 level1 lfo2;tab-stops:list 18.0pt"><!--[if !supportLists]--><span lang="EN-US">2.<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">ODM
Designer is like a back office where it is possible to design a study and its
protocol (study events, forms, items …)<o:p></o:p></span></p><p class="MsoListParagraphCxSpLast" style="margin-left:18.0pt;mso-add-space:auto"><span lang="EN-US">&nbsp;</span></p><p class="MsoNormal"><span lang="EN-US">The
Digitalis system is composed of the following components and sub-components:<o:p></o:p></span></p><ul><li style="text-indent: -18pt;"><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US"><span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp; &nbsp; &nbsp; &nbsp;&nbsp;</span></span><!--[endif]--><span lang="EN-US">Account
validation<o:p></o:p></span></li><li style="text-indent: -18pt;"><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US"><span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp; &nbsp; &nbsp; &nbsp; &nbsp;</span></span><!--[endif]--><span lang="EN-US">Authentication<o:p></o:p></span></li><li style="text-indent: -18pt;"><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US"><span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp; &nbsp; &nbsp; &nbsp; &nbsp;</span></span><!--[endif]--><span lang="EN-US">Dashboard<o:p></o:p></span></li><li style="text-indent: -18pt;"><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US"><span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp; &nbsp; &nbsp; &nbsp; &nbsp;</span></span><!--[endif]--><span lang="EN-US">Documents<o:p></o:p></span></li><li style="text-indent: -18pt;"><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US"><span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp; &nbsp; &nbsp; &nbsp;&nbsp;</span></span><!--[endif]--><span lang="EN-US">Manage:<o:p></o:p></span></li></ul><p style="margin-left: 72pt; text-indent: -18pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:&quot;Courier New&quot;;mso-fareast-font-family:&quot;Courier New&quot;;
mso-ansi-language:EN-US">o<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">Accounts<o:p></o:p></span></p><p style="margin-left: 72pt; text-indent: -18pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:&quot;Courier New&quot;;mso-fareast-font-family:&quot;Courier New&quot;;
mso-ansi-language:EN-US">o<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">Administration<o:p></o:p></span></p><p style="margin-left: 72pt; text-indent: -18pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:&quot;Courier New&quot;;mso-fareast-font-family:&quot;Courier New&quot;;
mso-ansi-language:EN-US">o<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">Clinical
data<o:p></o:p></span></p><p style="margin-left: 72pt; text-indent: -18pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:&quot;Courier New&quot;;mso-fareast-font-family:&quot;Courier New&quot;;
mso-ansi-language:EN-US">o<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">Databases<o:p></o:p></span></p><p style="margin-left: 72pt; text-indent: -18pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:&quot;Courier New&quot;;mso-fareast-font-family:&quot;Courier New&quot;;
mso-ansi-language:EN-US">o<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">Study
design<o:p></o:p></span></p><ul><li style="text-indent: -18pt;"><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US"><span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp; &nbsp; &nbsp; &nbsp;&nbsp;</span></span><!--[endif]--><span lang="EN-US">Orders<o:p></o:p></span></li><li style="text-indent: -18pt;"><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US"><span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp; &nbsp; &nbsp; &nbsp; &nbsp;</span></span><!--[endif]--><span lang="EN-US">Subject
forms (eCRF) <o:p></o:p></span></li><li style="text-indent: -18pt;"><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US"><span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp; &nbsp; &nbsp; &nbsp; &nbsp;</span></span><!--[endif]--><span lang="EN-US">Subjects
list<o:p></o:p></span></li><li style="text-indent: -18pt;"><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US"><span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp; &nbsp; &nbsp; &nbsp; &nbsp;</span></span><!--[endif]--><span lang="EN-US">Queries</span></li><li style="text-indent: -18pt;"><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US"><span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp; &nbsp; &nbsp; &nbsp;&nbsp;</span></span><!--[endif]--><span lang="EN-US">User
profile<o:p></o:p></span></li></ul><br/></div><br/></li><div class='pageInside'><li class='title-2 li_spec'>3.2.   Hardware architecture and location<br/></div><div class='texte'><p class="MsoNormal"><span lang="EN-US">This
project is based on a system installed on a web server. This web server is a
dedicated virtual machine provided by a hosting company (OVH) and physically
situated in Gravelines, France.<o:p></o:p></span></p><br/></div><br/></li><div class='pageInside'><li class='title-2 li_spec'>3.3.   System responsibilities<br/></div><div class='texte'><p class="MsoNormal"><span lang="EN-US">The
installation and maintenance of the physical and system environment are under
the responsibility of<span style="color:blue"> Cerebellis IT Department.</span><o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-US">The system
ownership is under the responsibility of <span style="color:blue">Cerebellis
General Department.<o:p></o:p></span></span></p><p class="MsoNormal"><span lang="EN-US">The system
validation status is under the responsibility of the business owners.</span></p><div><div><div id="_com_2" class="msocomtxt" language="JavaScript">

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</div><br/></div><br/></li><div class='pageInside'><li class='title-2 li_spec'>3.4.   System Responsibilities table<br/></div><div class='texte'><table align='center' class='normal_table'><tr class='first_lign'><td class='normal_cell'>Role</td><td class='normal_cell'>Identified Unit (Department/Area)</td></tr><tr><td class='normal_cell'>Business Owner</td><td class='normal_cell'>Cerebellis General Department</td></tr><tr><td class='normal_cell'>Technical Unit</td><td class='normal_cell'>Cerebellis IT Department</td></tr><tr><td class='normal_cell'>Quality Unit</td><td class='normal_cell'>Cerebellis Quality Department</td></tr></table><br/></div><br/></li><div class='pageInside'><li class='title-2 li_spec'>3.5.   System environments<br/></div><div class='texte'><p class="MsoNormal"><span lang="EN-US">Three
separate environments (hardware and software components) are available:<o:p></o:p></span></p><p>

</p><ol style="margin-top:0cm" start="1" type="1">
 <li class="MsoNormal" style="margin-top:4.0pt;margin-bottom:0cm;margin-bottom:
     .0001pt;text-align:left;mso-list:l0 level1 lfo1;tab-stops:list 36.0pt"><b><span lang="EN-US">Development:</span></b><span lang="EN-US"> This environment is dedicated to the technical staff for program
     development. It is hosted on developer’s local virtual machines.<o:p></o:p></span></li>
 <li class="MsoNormal" style="margin-top:4.0pt;margin-bottom:0cm;margin-bottom:
     .0001pt;text-align:left;mso-list:l0 level1 lfo1;tab-stops:list 36.0pt"><b><span lang="EN-US">Test/Validation:</span></b><span lang="EN-US"> This environment is dedicated to the technical staff for testing
     before implementation in production environment. This environment, where
     the validation testing is performed (IQ, OQ), is controlled: it is
     independent, equivalent or representative of the production environment. It
     also is the environment used for PQ test only once IQ and OQ phases have
     been closed. It is hosted on a dedicated virtual machine provided by OVH.<o:p></o:p></span></li>
 <li class="MsoNormal" style="margin-top:4.0pt;margin-bottom:0cm;margin-bottom:
     .0001pt;text-align:left;mso-list:l0 level1 lfo1;tab-stops:list 36.0pt"><b><span lang="EN-US">Production:</span></b><span lang="EN-US"> This environment is dedicated to the end users for their use. This
     environment is controlled: only authorized personnel are granted access to
     it. It is equivalent to the final Test/Validation and is only installed
     for clients’ use. It is installed following the same process than the
     qualified Test/Validation environment.<o:p></o:p></span></li>
</ol><br/></div><br/></li><div class='pageInside'><li class='title-2 li_spec'>3.6.   Configuration Management<br/></div><div class='pageInside'><li class='title-3 li_spec'>3.6.1.   Tools<br/></div><div class='texte'><p class="MsoNormal"><span lang="EN-US">Following
tools are used:<o:p></o:p></span></p><ul><li style="text-indent: -18pt;"><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US"><span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp; &nbsp; &nbsp; &nbsp; &nbsp;</span></span><!--[endif]--><span lang="EN-US">Mantis:
issues (proposals for change: corrections, evolutions or adaptations) are
tracked and managed with Mantis Bug Tracker, an open source and web-based issue
tracking manager hosted by Cerebellis.</span></li><li style="text-indent: -18pt;"><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US"><span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp; &nbsp; &nbsp; &nbsp;&nbsp;</span></span><!--[endif]--><span lang="EN-US">Git:
Digitalis source code is backup and stored in a code repository manage by Git,
an open source version control system hosted by Cerebellis. The list of
modifications to be released are also tracked with Git.<o:p></o:p></span></li></ul><br/></div><br/></li><div class='pageInside'><li class='title-3 li_spec'>3.6.2.   Version Numbering<br/></div><div class='texte'><p class="MsoNormal"><span lang="EN-US">Version
number is stored in the source code of Digitalis in the format YY.MM[.mm] where
YY stands for the year, MM for the month, and mm is optional for modifications
released during the month if any.<o:p></o:p></span></p><br/></div><br/></li><div class='pageInside'><li class='title-3 li_spec'>3.6.3.   Process<br/></div><div class='texte'><p class="MsoNormal"><span lang="EN-US">Mantis
issues are selected upon development of a new version of Digitalis and
correspond to change requests. Impact on processes and records, configuration
items and documentation are assessed collectively by Business Owner, Technical
Unit and Quality Unit before acceptation of issues for the new development.
Assessment details are based on business, technical and quality considerations
that are reported in Mantis for each assessed issue. Details may concern
product management (i.e. marketing point of view), source code management (e.g.
code reviews, refactoring, components integration, etc.), and quality
management (e.g. conformity to existing or new regulations).<o:p></o:p></span></p><p>

</p><p class="MsoNormal"><span lang="EN-US">Documentation,
tests and eventual other impacted items (training, procedures, etc.) are
updated in accordance with implemented issues.<o:p></o:p></span></p><br/></div><br/></li><br/></li><br/></li><div class='pageInside'><li class='title-1 li_spec'>4.   Risk Management Approach<hr><br/></div><div class='texte'><p class="MsoNormal"><a name="_Hlk10032548"><span lang="EN-US">The risk assessment is focused on GxP and business risks. The assessment
is based on regulatory requirements, user requirements and derived functionalities.<o:p></o:p></span></a></p><p>



</p><p class="MsoNormal"><span lang="EN-US">Based on
GAMP5 classification DIGITALIS is a Category 4 system.<o:p></o:p></span></p><br/></div><div class='pageInside'><li class='title-2 li_spec'>4.1.   Risk Assessment<br/></div><div class='texte'><p class="MsoNormal"><span lang="EN-US">The risk
will be assessed by determining an overall risk for each requirement and
specification based on a combination of risk Severity and risk Probability and
risk Detectability as follows:</span></p><p class="MsoNormal"><img src="http://127.0.0.1/csv-software/www/index.php?action=back.file.get&amp;file=images/risque_800x-.png" style="width: 800px;"></p><p class="MsoNormal" align="left"><b><span lang="EN-US">Severity</span></b><span lang="EN-US">: Impact on Patient Safety, Product
Quality, and Data Integrity (or other harm)<o:p></o:p></span></p><p class="MsoNormal" align="left"><b><span lang="EN-US">Probability</span></b><span lang="EN-US">: Likelihood of the fault occurring<o:p></o:p></span></p><p class="MsoNormal" align="left" style="text-indent: 35.4pt;"><b><span lang="EN-US">Risk Class</span></b><span lang="EN-US"> =
Severity x Probability<o:p></o:p></span></p><p class="MsoNormal" align="left"><b><span lang="EN-US">Detectability</span></b><span lang="EN-US">: Likelihood that the fault will be
noted before harm occurs<o:p></o:p></span></p><p class="MsoNormal">







</p><p class="MsoNormal" align="left"><b><span lang="EN-US">Risk</span></b><span lang="EN-US"> = Risk Class x Detectability<o:p></o:p></span></p><br/></div><br/></li><div class='pageInside'><li class='title-2 li_spec'>4.2.   Functional Risk Assessment<br/></div><div class='texte'><p class="MsoNormal"><span lang="EN-US">The risk of
requirements and functional specifications will be performed in the
corresponding deliverables (URS and FS). Each requirement and functional specification
will be assessed as described in the previous section.<o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-US">During the
Qualification phases tests will be designed based on the Risk assessed to show
all functionalities work as designed or that an efficient functional or
technical measure is in place to mitigate any risk of failure:<o:p></o:p></span></p><ul><li style="text-indent: -18pt;"><span lang="EN-US"><span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp; &nbsp; &nbsp; &nbsp; &nbsp;&nbsp;</span></span><!--[endif]--><span lang="EN-US">High
risk (scores 1 and 2) URS and FS will be tested directly with positive and negative test cases</span><span class="MsoCommentReference"><span style="font-size:8.0pt;mso-ascii-font-family:
Calibri;mso-fareast-font-family:Calibri;mso-hansi-font-family:Calibri;
mso-bidi-font-family:Calibri">&nbsp;</span></span><span lang="EN-US">with evidences. <o:p></o:p></span></li><li style="text-indent: -18pt;"><span lang="EN-US"><span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp; &nbsp; &nbsp; &nbsp; &nbsp;&nbsp;</span></span><!--[endif]--><span lang="EN-US">Medium
risk (scores 3 and 4) URS and FS will be tested directly at least with positive test cases</span><span class="MsoCommentReference"><span style="font-size:8.0pt;mso-ascii-font-family:
Calibri;mso-fareast-font-family:Calibri;mso-hansi-font-family:Calibri;
mso-bidi-font-family:Calibri">&nbsp;</span></span><span lang="EN-US">with evidences if they provide
additional value to the test (context, cover multiple steps / tests, etc.).<o:p></o:p></span></li><li style="text-indent: -18pt;"><span lang="EN-US"><span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp; &nbsp; &nbsp; &nbsp; &nbsp;&nbsp;</span></span><!--[endif]--><span lang="EN-US">Low
Risk (scores 6 and 9) URS and FS may be tested indirectly via testing of other
functionalities or during PQ.<o:p></o:p></span></li></ul><p>









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</div><br/></div><br/></li><br/></li><div class='pageInside'><li class='title-1 li_spec'>5.   Validation Strategy<hr><br/></div><div class='texte'><p class="MsoNormal"><span lang="EN-US">The
validation strategy consists in the validation phases:<o:p></o:p></span></p><p class="MsoListParagraphCxSpFirst" style="margin-top:4.0pt;margin-right:0cm;
margin-bottom:0cm;margin-left:36.0pt;margin-bottom:.0001pt;mso-add-space:auto;
text-indent:-18.0pt;mso-list:l0 level1 lfo1"><!--[if !supportLists]--><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US">·<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><b><span lang="EN-US">Analysis and Design:<o:p></o:p></span></b></p><p class="MsoListParagraphCxSpMiddle" style="margin-top:4.0pt;margin-right:0cm;
margin-bottom:0cm;margin-left:72.0pt;margin-bottom:.0001pt;mso-add-space:auto;
text-indent:-18.0pt;mso-list:l0 level2 lfo1"><!--[if !supportLists]--><span lang="EN-US" style="font-family:&quot;Courier New&quot;;mso-fareast-font-family:&quot;Courier New&quot;;
mso-ansi-language:EN-US">o<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><b><span lang="EN-US">User Requirements Specifications
(URS): </span></b><span lang="EN-US">it describes
the business needs for what users require from the system.<o:p></o:p></span></p><p class="MsoListParagraphCxSpMiddle" style="margin-top:0cm;margin-right:0cm;
margin-bottom:0cm;margin-left:72.0pt;margin-bottom:.0001pt;mso-add-space:auto;
text-indent:-18.0pt;mso-list:l0 level2 lfo1"><!--[if !supportLists]--><span lang="EN-US" style="font-family:&quot;Courier New&quot;;mso-fareast-font-family:&quot;Courier New&quot;;
mso-ansi-language:EN-US">o<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><b><span lang="EN-US">Functional Specification (FS):</span></b><span lang="EN-US"> it specifies the functions that a
system or component must perform and that answers needs from the URS.<b><o:p></o:p></b></span></p><p class="MsoListParagraphCxSpMiddle" style="margin-top:0cm;margin-right:0cm;
margin-bottom:0cm;margin-left:72.0pt;margin-bottom:.0001pt;mso-add-space:auto;
text-indent:-18.0pt;mso-list:l0 level2 lfo1"><!--[if !supportLists]--><span lang="EN-US" style="font-family:&quot;Courier New&quot;;mso-fareast-font-family:&quot;Courier New&quot;;
mso-ansi-language:EN-US">o<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><b><span lang="EN-US">Validation Plan (VP): </span></b><span lang="EN-US">it defines the scope and goals of a
validation project.<b><o:p></o:p></b></span></p><p class="MsoListParagraphCxSpMiddle" style="margin-top:0cm;margin-right:0cm;
margin-bottom:0cm;margin-left:36.0pt;margin-bottom:.0001pt;mso-add-space:auto;
text-indent:-18.0pt;mso-list:l0 level1 lfo1"><!--[if !supportLists]--><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US">·<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><b><span lang="EN-US">Installation Qualification (IQ):</span></b><span lang="EN-US"> it describes the process that is to
be followed when installing the system in an environment. This environment may
be a testing, validation, or production environment. IQ represents the
controls, instructions and verification steps of the successful installation
into the new environment.<o:p></o:p></span></p><p class="MsoListParagraphCxSpMiddle" style="margin-top:0cm;margin-right:0cm;
margin-bottom:0cm;margin-left:36.0pt;margin-bottom:.0001pt;mso-add-space:auto;
text-indent:-18.0pt;mso-list:l0 level1 lfo1"><!--[if !supportLists]--><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US">·<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><b><span lang="EN-US">Operational Qualification (OQ):</span></b><span lang="EN-US"> it includes functionality test
steps, test results, test reports and any testing problem reports.<o:p></o:p></span></p><p class="MsoListParagraphCxSpLast" style="margin-top:0cm;margin-right:0cm;
margin-bottom:12.0pt;margin-left:36.0pt;mso-add-space:auto;text-indent:-18.0pt;
mso-list:l0 level1 lfo1"><!--[if !supportLists]--><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US">·<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><b><span lang="EN-US">Performance Qualification (PQ):</span></b><span lang="EN-US"> It is a high-level testing based on
a routine use workflow. It allows to verify that the procedures and
computerized system work together and that routine users (with routine access
levels) can actually operate the system in a compliant manner. <o:p></o:p></span></p><p>















</p><p class="MsoNormal" style="margin-top:4.0pt;margin-right:0cm;margin-bottom:12.0pt;
margin-left:0cm"><span lang="EN-US">Qualification
is a systematic way of defining and verifying that the system is developed and
installed in accordance with its specifications and is fit for purpose.<o:p></o:p></span></p><br/></div><div class='pageInside'><li class='title-2 li_spec'>5.1.   Traceability<br/></div><div class='texte'><ul><li style="text-indent: -18pt;"><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US"><span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp; &nbsp; &nbsp; &nbsp; &nbsp;</span></span><!--[endif]--><span lang="EN-US">User
requirements and specifications are uniquely identified for traceability.<o:p></o:p></span></li><li style="text-indent: -18pt;"><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US"><span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp; &nbsp; &nbsp; &nbsp; &nbsp;</span></span><!--[endif]--><span lang="EN-US">The
link between the requirements and the specifications developed to meet them is
included in the design and qualification documentation.</span></li><li style="text-indent: -18pt;"><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US"><span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp; &nbsp; &nbsp; &nbsp; &nbsp;</span></span><!--[endif]--><span lang="EN-US">Each
test performed will be linked to the system specifications(s) by indicating the
specification(s) references(s) in regard of the test description or
alternatively the test(s) reference(s) in regard of the system specification(s).<o:p></o:p></span></li></ul><br/></div><br/></li><div class='pageInside'><li class='title-2 li_spec'>5.2.   Analysis and Design<br/></div><div class='texte'><p class="MsoNormal"><span lang="EN-US">Since the
system has already been designed, the Analysis and Design Phase will only
include the corresponding documentation with this VP, as well as URS and FS.<o:p></o:p></span></p><br/></div><br/></li><div class='pageInside'><li class='title-2 li_spec'>5.3.   Installation Qualification<br/></div><div class='pageInside'><li class='title-3 li_spec'>5.3.1.   Steps<br/></div><div class='texte'><p class="MsoNormal"><span lang="EN-US">Installation
qualification aims to ensure that computerized system is properly installed in
the right environment.<o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-US">The scope
of this IQ includes: <o:p></o:p></span></p><p class="MsoListParagraphCxSpFirst" align="left" style="margin: 0cm 0cm 0.0001pt 54pt; text-indent: -18pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US">·<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">As
the system is on the cloud, verifying:<o:p></o:p></span></p><p class="MsoListParagraphCxSpMiddle" align="left" style="margin: 0cm 0cm 0.0001pt 90pt; text-indent: -18pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:&quot;Courier New&quot;;mso-fareast-font-family:&quot;Courier New&quot;;
mso-ansi-language:EN-US">o<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">Cloud
servers settings and characteristics,<o:p></o:p></span></p><p class="MsoListParagraphCxSpMiddle" align="left" style="margin: 0cm 0cm 0.0001pt 90pt; text-indent: -18pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:&quot;Courier New&quot;;mso-fareast-font-family:&quot;Courier New&quot;;
mso-ansi-language:EN-US">o<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">Contract
with the cloud service provider,<o:p></o:p></span></p><p class="MsoListParagraphCxSpMiddle" align="left" style="margin: 0cm 0cm 0.0001pt 54pt; text-indent: -18pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US">·<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">Verifying
that software environment settings and characteristics match environment
requirements:<o:p></o:p></span></p><p class="MsoListParagraphCxSpMiddle" align="left" style="margin: 0cm 0cm 0.0001pt 90pt; text-indent: -18pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:&quot;Courier New&quot;;mso-fareast-font-family:&quot;Courier New&quot;;
mso-ansi-language:EN-US">o<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">Operating
system version,<o:p></o:p></span></p><p class="MsoListParagraphCxSpMiddle" align="left" style="margin: 0cm 0cm 0.0001pt 90pt; text-indent: -18pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:&quot;Courier New&quot;;mso-fareast-font-family:&quot;Courier New&quot;;
mso-ansi-language:EN-US">o<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">Server
web stack versions (web server and databases),<o:p></o:p></span></p><p class="MsoListParagraphCxSpMiddle" align="left" style="margin: 0cm 0cm 0.0001pt 54pt; text-indent: -18pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US">·<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">Verifying
that software documentation is available and in the right version:<o:p></o:p></span></p><p class="MsoListParagraphCxSpMiddle" align="left" style="margin: 0cm 0cm 0.0001pt 90pt; text-indent: -18pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:&quot;Courier New&quot;;mso-fareast-font-family:&quot;Courier New&quot;;
mso-ansi-language:EN-US">o<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">Installation,
administration and user manual,<o:p></o:p></span></p><p class="MsoListParagraphCxSpMiddle" align="left" style="margin: 0cm 0cm 0.0001pt 54pt; text-indent: -18pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US">·<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">Installing
software, if applicable,<o:p></o:p></span></p><p class="MsoListParagraphCxSpMiddle" align="left" style="margin: 0cm 0cm 0.0001pt 54pt; text-indent: -18pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US">·<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">Verifying
that software is properly installed:<o:p></o:p></span></p><p class="MsoListParagraphCxSpMiddle" align="left" style="margin: 0cm 0cm 0.0001pt 90pt; text-indent: -18pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:&quot;Courier New&quot;;mso-fareast-font-family:&quot;Courier New&quot;;
mso-ansi-language:EN-US">o<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">Software
version,<o:p></o:p></span></p><p class="MsoListParagraphCxSpMiddle" align="left" style="margin: 0cm 0cm 0.0001pt 90pt; text-indent: -18pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:&quot;Courier New&quot;;mso-fareast-font-family:&quot;Courier New&quot;;
mso-ansi-language:EN-US">o<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">Installation
results records (log files, screen shots…),<o:p></o:p></span></p><p class="MsoListParagraphCxSpMiddle" align="left" style="margin: 0cm 0cm 0.0001pt 54pt; text-indent: -18pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US">·<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">Configuring
software,<o:p></o:p></span></p><p class="MsoListParagraphCxSpMiddle" align="left" style="margin: 0cm 0cm 0.0001pt 54pt; text-indent: -18pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US">·<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">Verifying
that software is properly configured:<o:p></o:p></span></p><p class="MsoListParagraphCxSpMiddle" align="left" style="margin: 0cm 0cm 0.0001pt 90pt; text-indent: -18pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:&quot;Courier New&quot;;mso-fareast-font-family:&quot;Courier New&quot;;
mso-ansi-language:EN-US">o<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">Configuration
settings,<o:p></o:p></span></p><p>

































</p><p class="MsoListParagraphCxSpLast" align="left" style="margin: 0cm 0cm 0.0001pt 90pt; text-indent: -18pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:&quot;Courier New&quot;;mso-fareast-font-family:&quot;Courier New&quot;;
mso-ansi-language:EN-US">o<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">Configuration
steps logs.<o:p></o:p></span></p><br/></div><br/></li><div class='pageInside'><li class='title-3 li_spec'>5.3.2.   Documentation and Records<br/></div><div class='texte'><p class="MsoNormal"><span lang="EN-US">The
installation qualification documentation contains:<o:p></o:p></span></p><p class="MsoListParagraphCxSpFirst" align="left" style="margin: 0cm 0cm 0.0001pt 36pt; text-indent: -18pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US">·<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">An
installation qualification protocol containing all the verification/inspections
required,<o:p></o:p></span></p><p class="MsoListParagraphCxSpMiddle" align="left" style="margin: 0cm 0cm 0.0001pt 36pt; text-indent: -18pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US">·<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">One
or more installation qualification reports containing results of installation
qualification,<o:p></o:p></span></p><p class="MsoListParagraphCxSpMiddle" align="left" style="margin: 0cm 0cm 0.0001pt 36pt; text-indent: -18pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US">·<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">Any
additional record serving as evidence of installation qualification,<o:p></o:p></span></p><p>







</p><p class="MsoListParagraphCxSpLast" align="left" style="margin: 0cm 0cm 0.0001pt 36pt; text-indent: -18pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US">·<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">Bug
reports found during installation qualification.<o:p></o:p></span></p><br/></div><br/></li><br/></li><div class='pageInside'><li class='title-2 li_spec'>5.4.   Operational Qualification<br/></div><div class='pageInside'><li class='title-3 li_spec'>5.4.1.   Steps<br/></div><div class='texte'><p class="MsoNormal"><span lang="EN-US">Operational
qualification aims to ensure that every function of the computerized system is
working as expected.<o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-US">The scope
of OQ testing includes, as applicable:<o:p></o:p></span></p><p class="MsoListParagraphCxSpFirst" align="left" style="margin: 0cm 0cm 0.0001pt 54pt; text-indent: -18pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US">·<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">Functional
and performance requirements,<o:p></o:p></span></p><p class="MsoListParagraphCxSpMiddle" align="left" style="margin: 0cm 0cm 0.0001pt 90pt; text-indent: -18pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:&quot;Courier New&quot;;mso-fareast-font-family:&quot;Courier New&quot;;
mso-ansi-language:EN-US">o<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">Verifying
software functions,<o:p></o:p></span></p><p class="MsoListParagraphCxSpMiddle" align="left" style="margin: 0cm 0cm 0.0001pt 90pt; text-indent: -18pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:&quot;Courier New&quot;;mso-fareast-font-family:&quot;Courier New&quot;;
mso-ansi-language:EN-US">o<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">Security,
safety and privacy,<o:p></o:p></span></p><p class="MsoListParagraphCxSpMiddle" align="left" style="margin: 0cm 0cm 0.0001pt 54pt; text-indent: -18pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US">·<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">Non-functional
requirements, like<o:p></o:p></span></p><p class="MsoListParagraphCxSpMiddle" align="left" style="margin: 0cm 0cm 0.0001pt 90pt; text-indent: -18pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:&quot;Courier New&quot;;mso-fareast-font-family:&quot;Courier New&quot;;
mso-ansi-language:EN-US">o<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">Administration
functions,<o:p></o:p></span></p><p class="MsoListParagraphCxSpMiddle" align="left" style="margin: 0cm 0cm 0.0001pt 90pt; text-indent: -18pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:&quot;Courier New&quot;;mso-fareast-font-family:&quot;Courier New&quot;;
mso-ansi-language:EN-US">o<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">Maintenance
functions,<o:p></o:p></span></p><p>















</p><p class="MsoListParagraphCxSpLast" align="left" style="margin: 0cm 0cm 0.0001pt 90pt; text-indent: -18pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:&quot;Courier New&quot;;mso-fareast-font-family:&quot;Courier New&quot;;
mso-ansi-language:EN-US">o<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">21
Part 11 compliance.<o:p></o:p></span></p><br/></div><br/></li><div class='pageInside'><li class='title-3 li_spec'>5.4.2.   Documentation and Records<br/></div><div class='texte'><p class="MsoNormal"><span lang="EN-US">The
performance qualification documentation contains:<o:p></o:p></span></p><p class="MsoListParagraphCxSpFirst" align="left" style="margin: 0cm 0cm 0.0001pt 36pt; text-indent: -18pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US">·<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">Optionally,
a performance qualification protocol containing verifications of user
requirements,<o:p></o:p></span></p><p class="MsoListParagraphCxSpMiddle" align="left" style="margin: 0cm 0cm 0.0001pt 36pt; text-indent: -18pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US">·<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">One
or more performance qualification reports containing feedback of users,
discovered bugs, …<o:p></o:p></span></p><p class="MsoListParagraphCxSpMiddle" align="left" style="margin: 0cm 0cm 0.0001pt 36pt; text-indent: -18pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US">·<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">Optionally,
any record serving as evidence of performance qualification,<o:p></o:p></span></p><p>







</p><p class="MsoListParagraphCxSpLast" align="left" style="margin: 0cm 0cm 0.0001pt 36pt; text-indent: -18pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US">·<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">Bug
reports found during performance qualification.<o:p></o:p></span></p><br/></div><br/></li><br/></li><div class='pageInside'><li class='title-2 li_spec'>5.5.   Deviations Management<br/></div><div class='pageInside'><li class='title-3 li_spec'>5.5.1.   Deviations from requirements and specifications (Incidents)<br/></div><div class='texte'><p class="MsoNormal"><span lang="EN-US">Deviations
and software bugs are recorded in Mantis Bug Tracker.<o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-US">The
severity of deviations is assessed with the following criteria:<o:p></o:p></span></p><p class="MsoListParagraphCxSpFirst" style="text-indent:-18.0pt;mso-list:l5 level1 lfo4"><!--[if !supportLists]--><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US">·<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">Major:
major non-compliance or functionality not working without a workaround,<o:p></o:p></span></p><p class="MsoListParagraphCxSpMiddle" style="text-indent:-18.0pt;mso-list:l1 level1 lfo2"><!--[if !supportLists]--><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US">·<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">Medium:
non-compliance or functionality not working but with a workaround,<o:p></o:p></span></p><p class="MsoListParagraphCxSpLast" align="left" style="margin: 0cm 0cm 0.0001pt 36pt; text-indent: -18pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US">·<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">Minor:
No non-compliance but software behavior is outside of specifications.<o:p></o:p></span></p><p class="MsoNormal" align="left" style="margin: 0cm 0cm 0.0001pt;"><span lang="EN-US">&nbsp;</span></p><p class="MsoNormal" align="left" style="margin: 0cm 0cm 0.0001pt;"><span lang="EN-US">The priority
of deviations is assessed with the following criteria:<o:p></o:p></span></p><p class="MsoListParagraphCxSpFirst" align="left" style="margin: 0cm 0cm 0.0001pt 36pt; text-indent: -18pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US">·<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">High:
resolution cannot be postponed to a new version or is critical for compliance<o:p></o:p></span></p><p class="MsoListParagraphCxSpMiddle" align="left" style="margin: 0cm 0cm 0.0001pt 36pt; text-indent: -18pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US">·<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">Normal:
resolution should be done without prior consideration<o:p></o:p></span></p><p class="MsoListParagraphCxSpLast" align="left" style="margin: 0cm 0cm 0.0001pt 36pt; text-indent: -18pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US">·<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">Low:
resolution is neither considered as mandatory or urgent <o:p></o:p></span></p><p class="MsoNormal" align="left" style="margin: 0cm 0cm 0.0001pt;"><span lang="EN-US">&nbsp;</span></p><p class="MsoNormal" align="left" style="margin: 0cm 0cm 0.0001pt;"><span lang="EN-US">The
responsibilities related to deviations management are:<o:p></o:p></span></p><p class="MsoListParagraphCxSpFirst" align="left" style="margin: 0cm 0cm 0.0001pt 36pt; text-indent: -18pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US">·<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">Technical
Unit, Business Owner and Quality can report deviations (whoever found it).<o:p></o:p></span></p><p class="MsoListParagraphCxSpMiddle" align="left" style="margin: 0cm 0cm 0.0001pt 36pt; text-indent: -18pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US">·<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">Technical
Unit describes the technical analyses of the root cause of the deviation,
proposes a corrective action and assesses technical impact for resolution.<o:p></o:p></span></p><p class="MsoListParagraphCxSpLast" align="left" style="margin: 0cm 0cm 0.0001pt 36pt; text-indent: -18pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US">·<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">Business
Owner defines the severity and Quality defines the priority.<o:p></o:p></span></p><p class="MsoNormal" align="left" style="margin: 0cm 0cm 0.0001pt;"><span lang="EN-US">&nbsp;</span></p><p class="MsoNormal"><span lang="EN-US">Corrective
action should include, where applicable, revision of requirements and
specifications, version changes to software, and re-testing.<o:p></o:p></span></p><p>

































</p><p class="MsoNormal"><span lang="EN-US">All
incidents must be analyzed and reviewed by QA.<o:p></o:p></span></p><br/></div><br/></li><div class='pageInside'><li class='title-3 li_spec'>5.5.2.   Deviations from the validation plan<br/></div><div class='texte'><p class="MsoNormal"><span lang="EN-US">Deviations
during qualification testing like anomalies, incident and non-conformity
reports or log, must be reviewed by the Business Responsible who will decide
what should be done (amendment to this plan, further steps, amendments to
protocols, etc.).<o:p></o:p></span></p><p>

</p><p class="MsoNormal"><span lang="EN-US">Deviations
from validation plan will be listed, and justified/explained in the validation
report.<o:p></o:p></span></p><br/></div><br/></li><br/></li><br/></li><div class='pageInside'><li class='title-1 li_spec'>6.   Validation Reports<hr><br/></div><div class='pageInside'><li class='title-2 li_spec'>6.1.   Qualification reports<br/></div><div class='texte'><p class="MsoNormal"><span lang="EN-US">Reports are
required to summarize each of the qualification phases of the validation
project.&nbsp; <o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-US">All
qualification reports must address the following:<o:p></o:p></span></p><p class="MsoListParagraphCxSpFirst" align="left" style="margin: 0cm 0cm 0.0001pt 36pt; text-indent: -18pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US">·<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">An
overall summary of the results,<o:p></o:p></span></p><p class="MsoListParagraphCxSpMiddle" align="left" style="margin: 0cm 0cm 0.0001pt 36pt; text-indent: -18pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US">·<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">Inclusion
or reference of the location of the qualification documentation (approved and executed
tests protocols),<o:p></o:p></span></p><p class="MsoListParagraphCxSpMiddle" align="left" style="margin: 0cm 0cm 0.0001pt 36pt; text-indent: -18pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US">·<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">Discussion
of all deviations, corrective actions, and resulting changes (especially bug
fixes between IQ and OQ or OQ and PQ)<o:p></o:p></span></p><p>









</p><p class="MsoListParagraphCxSpLast" align="left" style="margin: 0cm 0cm 0.0001pt 36pt; text-indent: -18pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US">·<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">A
conclusion that includes conditions for use of the system.<o:p></o:p></span></p><br/></div><br/></li><div class='pageInside'><li class='title-2 li_spec'>6.2.   Phases sequence<br/></div><div class='texte'><p class="MsoNormal"><span lang="EN-US">Successful
completion of IQ as shown in the IQ report (with conditions if any) will allow
to perform OQ.<o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-US">OQ
completion will be summarized in the OQ report which will allow to move on to
PQ (with conditions if any).<o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-US">IQ, OQ and
PQ phases can be summarized in an intermediary Validation Report to allow
release of the system with open non-blocking anomalies if any.<o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-US">Then the PQ
phase will be carried out before the final Validation Report can be issued
(again if an intermediary Validation Report was issued).<o:p></o:p></span></p><p>







</p><p class="MsoNormal"><span lang="EN-US">A list of
all anomalies which were detected during each qualification phase will be
included in each qualification and validation report. Corrective measures and
closure of all anomalies is required before issuing the Final Validation
Report.<o:p></o:p></span></p><br/></div><br/></li><div class='pageInside'><li class='title-2 li_spec'>6.3.   Conditional Acceptance<br/></div><div class='texte'><p class="MsoNormal"><span lang="EN-US">If any
anomaly remains open the system may be approved for use under certain
conditions. These anomalies and acceptance conditions must be explained in the
Validation Report that will remain as an Intermediary Validation Report until
they are all cleared.<o:p></o:p></span></p><br/></div><br/></li><div class='pageInside'><li class='title-2 li_spec'>6.4.   Final Acceptance<br/></div><div class='texte'><p class="MsoNormal"><span lang="EN-US">Once all
anomalies have been closed or after a significant period of operational use,
the validation status of the system is re-evaluated in terms of the acceptance
criteria to provide the Validated status to the system. This is summarized in
the Final Validation Report.<o:p></o:p></span></p><br/></div><br/></li><div class='pageInside'><li class='title-2 li_spec'>6.5.   Validation Report<br/></div><div class='texte'><p class="MsoNormal"><span lang="EN-US">A
Validation Report is required to verify the completion of all activities
required by the validation protocol.<o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-US">The
validation report must address the following:<o:p></o:p></span></p><p class="MsoNormal" align="left" style="margin: 0cm 0cm 0.0001pt 45.4pt; text-indent: -22.7pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US">·<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">An
overall summary of the validation project,<o:p></o:p></span></p><p class="MsoNormal" align="left" style="margin: 0cm 0cm 0.0001pt 45.4pt; text-indent: -22.7pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US">·<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">A
list of all deliverables generated as per the Validation Plan and their
location,<o:p></o:p></span></p><p class="MsoNormal" align="left" style="margin: 0cm 0cm 0.0001pt 45.4pt; text-indent: -22.7pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US">·<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">Any
deviation from the Validation Plan with justification,<o:p></o:p></span></p><p>









</p><p class="MsoNormal" align="left" style="margin: 0cm 0cm 0.0001pt 45.4pt; text-indent: -22.7pt;"><!--[if !supportLists]--><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US">·<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><span lang="EN-US">A
clear conclusion based on the acceptance criteria here below indicating whether
or not the system is suitable for use in routine operations.<o:p></o:p></span></p><br/></div><br/></li><div class='pageInside'><li class='title-2 li_spec'>6.6.   Validation Report Table<br/></div><div class='texte'><table align='center' class='normal_table'><tr class='first_lign'><td class='normal_cell'>Acceptance Criteria ID</td><td class='normal_cell'>Acceptance Criteria Description</td></tr><tr><td class='normal_cell'>AC-1</td><td class='normal_cell'>The system functionalities comply with user requirements and the regulations (approved documentation and qualifications performed).</td></tr><tr><td class='normal_cell'>AC-2</td><td class='normal_cell'>There are no malfunctions with the system functionalities (no open non-conformity)</td></tr><tr><td class='normal_cell'>AC-3</td><td class='normal_cell'>The system is available and operates adequately in use (successful PQ).</td></tr><tr><td class='normal_cell'>AC-4</td><td class='normal_cell'>The validation steps and deliverables comply with the Validation Plan (with deviations from VP well justified if any).</td></tr></table><br/></div><div class='texte'><caption>Acceptance criteria table</caption><br/></div><br/></li><div class='pageInside'><li class='title-2 li_spec'>6.7.   Validation Report Follow<br/></div><div class='texte'><p class="MsoNormal"><span lang="EN-US">Each
criterion is checked according to the following scale:<o:p></o:p></span></p><p class="MsoListParagraphCxSpFirst" style="margin-bottom:0cm;margin-bottom:.0001pt;
mso-add-space:auto;text-indent:-18.0pt;mso-list:l0 level1 lfo1"><!--[if !supportLists]--><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US">·<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><i><span lang="EN-US">Compliant</span></i><span lang="EN-US"> (C): no anomalies found.<o:p></o:p></span></p><p class="MsoListParagraphCxSpMiddle" style="margin-top:0cm;margin-right:0cm;
margin-bottom:0cm;margin-left:36.0pt;margin-bottom:.0001pt;mso-add-space:auto;
text-indent:-18.0pt;mso-list:l0 level1 lfo1"><!--[if !supportLists]--><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US">·<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><i><span lang="EN-US">Non-Compliant</span></i><span lang="EN-US"> (NC): anomalies have been reported
and the process of system implementation must then be deferred until they have
been cleared up.<o:p></o:p></span></p><p class="MsoListParagraphCxSpLast" style="margin-top:0cm;margin-right:0cm;
margin-bottom:0cm;margin-left:36.0pt;margin-bottom:.0001pt;mso-add-space:auto;
text-indent:-18.0pt;mso-list:l0 level1 lfo1"><!--[if !supportLists]--><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US">·<span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
</span></span><!--[endif]--><i><span lang="EN-US">Non-Compliant but Accepted with
conditions</span></i><span lang="EN-US"> (CAC):
anomalies have been reported but are not blocking, corrective measures and/or
work-arounds have been defined (see section 6.4 Conditional Acceptance).<o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-US">The
validation status of the system corresponds to the lowest level of compliance
of the 4 criteria listed above.<o:p></o:p></span></p><p class="MsoNormal"><span lang="EN-US">This
evaluation, as well as the list of anomalies detected at the time of
qualification or in production, and not cleared up after validation, is
presented in the Validation Report.<o:p></o:p></span></p><p>











</p><p class="MsoNormal"><span lang="EN-US">On the
basis of these results, the<span style="color:red"> </span>Business owner/
Process Owner and the System Owner finally gives permission for the system to be
used and record their decision by approving the Validation Report.<o:p></o:p></span></p><br/></div><br/></li><br/></li><div class='pageInside'><li class='title-1 li_spec'>7.   Delivrable Matrix<hr><br/></div><div class='pageInside'><li class='title-2 li_spec'>7.1.   Roles and Responsibilities<br/></div><div class='texte'><table align='center' class='normal_table'><tr class='first_lign'><td class='normal_cell'>Role</td><td class='normal_cell'>Responsibilities</td><td class='normal_cell'>Name, function / company</td><td class='normal_cell'>Project</td><td class='normal_cell'>Operation</td></tr><tr><td class='normal_cell'>Process Owner</td><td class='normal_cell'>•	Writes and/or reviews URS •	Writes and/or reviews FS in relation to the URS •	Writes and/or supports writing of qualifications protocols •	Supports qualification tests execution •	Running tests for system changes •	Key User Training</td><td class='normal_cell'>Cerebellis, Thomas Perraudin</td><td class='normal_cell'>x</td><td class='normal_cell'>x</td></tr><tr><td class='normal_cell'>Business Responsible</td><td class='normal_cell'>•	Carries out project management •	Perform CSV documentation maintenance or allocates resources to do so •	User Training</td><td class='normal_cell'>Cerebellis, Thomas Perraudin</td><td class='normal_cell'>x</td><td class='normal_cell'></td></tr><tr><td class='normal_cell'>Key User</td><td class='normal_cell'>•	Trained to use the system •	Execute qualification tests protocols</td><td class='normal_cell'></td><td class='normal_cell'>x</td><td class='normal_cell'></td></tr><tr><td class='normal_cell'>Technical Unit</td><td class='normal_cell'>•	Technical support (installation and functionalities) if necessary •	Writes or supports writing of FS •	Writes and/or reviews qualification protocols •	Support during qualifications / reviews anomalies •	Establishment of infrastructure during the project and operational phases •	Assistance with setting up the system during the project •	Realization of system changes in accordance with the Functional Specifications •	User Training  •	User support during the production phase</td><td class='normal_cell'>Cerebellis, Laurent Noyon</td><td class='normal_cell'>x</td><td class='normal_cell'>x</td></tr><tr><td class='normal_cell'>CSV</td><td class='normal_cell'>•	Writing Validation Plan and Report •	Support and review for most qualification documents including o	URS and FS (regarding risk analysis and regulatory compliance) o	IQ, OQ, PQ protocols (preparation and execution review)</td><td class='normal_cell'>Writee, Marie Euzen</td><td class='normal_cell'>x</td><td class='normal_cell'></td></tr><tr><td class='normal_cell'>QA</td><td class='normal_cell'>•	Responsible for Quality Assurance and regulatory support during the project phase •	Review and approval of Procedure if any •	Review and Approval of Validation Documents •	Review validation anomalies if needed •	Review and approval of changes during initial validation</td><td class='normal_cell'>Writee, Marie Euzen</td><td class='normal_cell'>x</td><td class='normal_cell'></td></tr><tr><td class='normal_cell'>QA</td><td class='normal_cell'>•	Responsible for Quality Assurance and regulatory support during the operational phase •	Review and approval of Procedure if any •	Validation anomalies review if needed</td><td class='normal_cell'>Cerebellis, Thomas Perraudin</td><td class='normal_cell'></td><td class='normal_cell'>x</td></tr></table><br/></div><br/></li><div class='pageInside'><li class='title-2 li_spec'>7.2.   Delivrables<br/></div><div class='texte'><p class="MsoNormal"><span lang="EN-US">The list of
deliverables for the validation of Digitalis is summarized in the matrix below,
with the following roles and responsibilities:<o:p></o:p></span></p><ul><li style="text-indent: -18pt;"><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US"><span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp; &nbsp; &nbsp; &nbsp; &nbsp;</span></span><!--[endif]--><b><span lang="EN-US">Responsible (R)</span></b><span lang="EN-US">: Individual who contributes to the
task completion within his area of expertise. There may be multiple Responsible
for each task. The responsible is a mandatory approver of the deliverable.<o:p></o:p></span></li><li style="text-indent: -18pt;"><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US"><span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp; &nbsp; &nbsp; &nbsp;&nbsp;</span></span><!--[endif]--><b><span lang="EN-US">Accountable (A):</span></b><span lang="EN-US"> Individual who is accountable of
task completion. He may be responsible in his area of expertise. There is one
and only one Accountable for each task. The accountable is a mandatory approver
of the deliverable.<o:p></o:p></span></li><li style="text-indent: -18pt;"><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US"><span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp; &nbsp; &nbsp; &nbsp; &nbsp;</span></span><!--[endif]--><b><span lang="EN-US">Informed (I)</span></b><span lang="EN-US">: Individual who is recommended to
be consulted by the Accountable or any Responsible prior to the task completion
and/or informed by the Accountable once the task has been completed.</span></li><li style="text-indent: -18pt;"><span lang="EN-US" style="font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:
Symbol;mso-ansi-language:EN-US"><span style="font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: &quot;Times New Roman&quot;;">&nbsp; &nbsp; &nbsp; &nbsp; &nbsp;</span></span><!--[endif]--><b><span lang="EN-US">Consulted (C)</span></b><span lang="EN-US">: Individual who is consulted for
the task completion.<o:p></o:p></span></li></ul><br/></div><br/></li><div class='pageInside'><li class='title-2 li_spec'>7.3.   Delivrables Table<br/></div><div class='texte'><table align='center' class='normal_table'><tr class='first_lign'><td class='normal_cell'>Delivrable</td><td class='normal_cell'>Process Owner</td><td class='normal_cell'>Business Responsible</td><td class='normal_cell'>Key User</td><td class='normal_cell'>Technical Unit</td><td class='normal_cell'>CSV</td><td class='normal_cell'>QA</td></tr><tr><td class='normal_cell'>Analysis /Design Phase</td><td class='normal_cell'>Analysis /Design Phase</td><td class='normal_cell'>Analysis /Design Phase</td><td class='normal_cell'>Analysis /Design Phase</td><td class='normal_cell'>Analysis /Design Phase</td><td class='normal_cell'>Analysis /Design Phase</td><td class='normal_cell'>Analysis /Design Phase</td></tr><tr><td class='normal_cell'>User Requirement Specification (URS)</td><td class='normal_cell'>A</td><td class='normal_cell'>C</td><td class='normal_cell'>-</td><td class='normal_cell'>R</td><td class='normal_cell'>R</td><td class='normal_cell'>R</td></tr><tr><td class='normal_cell'>Validation Plan (VP)</td><td class='normal_cell'>R</td><td class='normal_cell'>C</td><td class='normal_cell'>-</td><td class='normal_cell'>R</td><td class='normal_cell'>R</td><td class='normal_cell'>A</td></tr><tr><td class='normal_cell'>Functional Specification (FS)</td><td class='normal_cell'>A</td><td class='normal_cell'>C</td><td class='normal_cell'>-</td><td class='normal_cell'>R</td><td class='normal_cell'>R</td><td class='normal_cell'>R</td></tr><tr><td class='normal_cell'>Testing</td><td class='normal_cell'>Testing</td><td class='normal_cell'>Testing</td><td class='normal_cell'>Testing</td><td class='normal_cell'>Testing</td><td class='normal_cell'>Testing</td><td class='normal_cell'>Testing</td></tr><tr><td class='normal_cell'>IQ Protocol & Report </td><td class='normal_cell'>R</td><td class='normal_cell'>I</td><td class='normal_cell'>I</td><td class='normal_cell'>A</td><td class='normal_cell'>R</td><td class='normal_cell'>R</td></tr><tr><td class='normal_cell'>IQ Execution</td><td class='normal_cell'>I</td><td class='normal_cell'>I</td><td class='normal_cell'>A</td><td class='normal_cell'>R</td><td class='normal_cell'>R</td><td class='normal_cell'>R</td></tr><tr><td class='normal_cell'>OQ Protocol & Report</td><td class='normal_cell'>A</td><td class='normal_cell'>I</td><td class='normal_cell'>I</td><td class='normal_cell'>R</td><td class='normal_cell'>R</td><td class='normal_cell'>R</td></tr><tr><td class='normal_cell'>OQ Execution</td><td class='normal_cell'>I</td><td class='normal_cell'>I</td><td class='normal_cell'>A</td><td class='normal_cell'>R</td><td class='normal_cell'>R</td><td class='normal_cell'>R</td></tr><tr><td class='normal_cell'>Implementation</td><td class='normal_cell'>Implementation</td><td class='normal_cell'>Implementation</td><td class='normal_cell'>Implementation</td><td class='normal_cell'>Implementation</td><td class='normal_cell'>Implementation</td><td class='normal_cell'>Implementation</td></tr><tr><td class='normal_cell'>PQ Protocol & Report</td><td class='normal_cell'>A</td><td class='normal_cell'>I</td><td class='normal_cell'>I</td><td class='normal_cell'>R</td><td class='normal_cell'>R</td><td class='normal_cell'>R</td></tr><tr><td class='normal_cell'>PQ Execution</td><td class='normal_cell'>R</td><td class='normal_cell'>C</td><td class='normal_cell'>A</td><td class='normal_cell'>I</td><td class='normal_cell'>R</td><td class='normal_cell'>R</td></tr><tr><td class='normal_cell'>Validation Report</td><td class='normal_cell'>R</td><td class='normal_cell'>C</td><td class='normal_cell'>-</td><td class='normal_cell'>R</td><td class='normal_cell'>R</td><td class='normal_cell'>A</td></tr></table><br/></div><br/></li><br/></li><div class='pageInside'><li class='title-1 li_spec'>8.   References<hr><br/></div><div class='texte'><p class="MsoNormal"><span lang="EN-US">Digitalis-User
Requirements Specification-<span style="background:yellow;mso-highlight:yellow">version
1</span>.0<o:p></o:p></span></p><br/></div><br/></li></div>
      
    </div>
    
  </body>
</html>, 1, , Digitalis_VP- Version 1 - 2019-08-30 09:46:38- Signed -, Cerebellis - Digitalis, Validation Plan)