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-- Généré le :  ven. 30 août 2019 à 14:56
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-- Version de PHP :  7.2.18




--
-- Base de données :  `csv_software`
--

-- --------------------------------------------------------

--
-- Structure de la table `csv_software_acl`
--

CREATE TABLE IF NOT EXISTS `csv_software_acl` (
  `id` int(11) NOT NULL AUTO_INCREMENT,
  `id_user` int(11) NOT NULL,
  `id_project` int(11) NOT NULL,
  `role` varchar(100) NOT NULL,
  PRIMARY KEY (`id`)
) ENGINE=MyISAM AUTO_INCREMENT=52 DEFAULT CHARSET=utf8;

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-- Déchargement des données de la table `csv_software_acl`
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INSERT INTO `csv_software_acl` (`id`, `id_user`, `id_project`, `role`) VALUES
(51, 5, 40, 'redactor');

-- --------------------------------------------------------

--
-- Structure de la table `csv_software_category`
--

CREATE TABLE IF NOT EXISTS `csv_software_category` (
  `id` int(11) NOT NULL AUTO_INCREMENT,
  `category` varchar(255) NOT NULL,
  `acronym` varchar(20) NOT NULL,
  `id_project` int(11) NOT NULL,
  `id_chapter` int(255) NOT NULL,
  PRIMARY KEY (`id`)
) ENGINE=MyISAM AUTO_INCREMENT=217 DEFAULT CHARSET=utf8;

-- --------------------------------------------------------

--
-- Structure de la table `csv_software_chapter`
--

CREATE TABLE IF NOT EXISTS `csv_software_chapter` (
  `id` int(11) NOT NULL AUTO_INCREMENT,
  `name` varchar(255) NOT NULL,
  `annexe` int(1) DEFAULT NULL,
  `id_document` int(11) NOT NULL,
  PRIMARY KEY (`id`)
) ENGINE=MyISAM AUTO_INCREMENT=3319 DEFAULT CHARSET=utf8;

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-- Déchargement des données de la table `csv_software_chapter`
--

INSERT INTO `csv_software_chapter` (`id`, `name`, `annexe`, `id_document`) VALUES
(3239, 'Introduction', NULL, 444),
(3240, 'Purpose', NULL, 444),
(3241, 'Scope', NULL, 444),
(3242, 'Regulatory Scope', NULL, 444),
(3243, 'System scope & limitations', NULL, 444),
(3244, 'System Overview', NULL, 444),
(3245, 'Acronyms & Definitions', NULL, 444),
(3246, 'Acronyms', NULL, 444),
(3247, 'Definitions', NULL, 444),
(3248, 'System Definition', NULL, 444),
(3249, 'System Description', NULL, 444),
(3250, 'Hardware architecture and location', NULL, 444),
(3251, 'System responsibilities', NULL, 444),
(3252, 'System Responsibilities table', NULL, 444),
(3253, 'System environments', NULL, 444),
(3254, 'Configuration Management', NULL, 444),
(3255, 'Tools', NULL, 444),
(3256, 'Version Numbering', NULL, 444),
(3257, 'Process', NULL, 444),
(3258, 'Risk Management Approach', NULL, 444),
(3259, 'Risk Assessment', NULL, 444),
(3260, 'Functional Risk Assessment', NULL, 444),
(3261, 'Validation Strategy', NULL, 444),
(3262, 'Traceability', NULL, 444),
(3263, 'Analysis and Design', NULL, 444),
(3264, 'Installation Qualification', NULL, 444),
(3265, 'Steps', NULL, 444),
(3266, 'Documentation and Records', NULL, 444),
(3267, 'Operational Qualification', NULL, 444),
(3268, 'Steps', NULL, 444),
(3269, 'Documentation and Records', NULL, 444),
(3270, 'Deviations Management', NULL, 444),
(3271, 'Deviations from requirements and specifications (Incidents)', NULL, 444),
(3272, 'Deviations from the validation plan', NULL, 444),
(3273, 'Validation Reports', NULL, 444),
(3274, 'Qualification reports', NULL, 444),
(3275, 'Phases sequence', NULL, 444),
(3276, 'Conditional Acceptance', NULL, 444),
(3277, 'Final Acceptance', NULL, 444),
(3278, 'Validation Report', NULL, 444),
(3279, 'Validation Report Table', NULL, 444),
(3280, 'Validation Report Follow', NULL, 444),
(3281, 'Delivrable Matrix', NULL, 444),
(3282, 'Roles and Responsibilities', NULL, 444),
(3283, 'Delivrables', NULL, 444),
(3284, 'Delivrables Table', NULL, 444),
(3285, 'References', NULL, 444);

-- --------------------------------------------------------

--
-- Structure de la table `csv_software_content`
--

CREATE TABLE IF NOT EXISTS `csv_software_content` (
  `id` int(11) NOT NULL AUTO_INCREMENT,
  `id_chapter` int(11) NOT NULL,
  `title` varchar(255) DEFAULT NULL,
  `content` text,
  `type` varchar(50) NOT NULL,
  `row` int(1) DEFAULT NULL,
  PRIMARY KEY (`id`)
) ENGINE=MyISAM AUTO_INCREMENT=3229 DEFAULT CHARSET=utf8;

--
-- Déchargement des données de la table `csv_software_content`
--

INSERT INTO `csv_software_content` (`id`, `id_chapter`, `title`, `content`, `type`, `row`) VALUES
(3185, 3240, NULL, '<p class=\"MsoNormal\"><span lang=\"EN-US\">The purpose\r\nof this Validation Plan (VP) is to define the strategy, activities,\r\ndeliverables and responsibilities to be performed for the validation of the\r\nDIGITALIS system.<o:p></o:p></span></p><p class=\"MsoNormal\"><span lang=\"EN-US\">Its goal is\r\nto set the principles to:<o:p></o:p></span></p><ul style=\"margin-top:0cm\" type=\"disc\">\r\n <li class=\"MsoNormal\"><span lang=\"EN-US\">Bring evidences that involved processes\r\n     are compliant with quality and regulatory requirements,<o:p></o:p></span></li>\r\n <li class=\"MsoNormal\"><span lang=\"EN-US\">Ensure the safety and integrity of\r\n     critical data.<o:p></o:p></span></li>\r\n</ul><p class=\"MsoNormal\"><span lang=\"EN-US\">The\r\nobjective of validation is to demonstrate with a high level of confidence that\r\nthe system DIGITALIS will operate correctly when used, in terms of the scope of\r\nuse described in user requirements specifications and detailed functional\r\nspecifications of the system. <o:p></o:p></span></p><p>\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n</p><p class=\"MsoNormal\"><span lang=\"EN-US\">The results\r\nof the validation will be described in a Validation Report.<o:p></o:p></span></p>', 'text_wysiwyg', NULL),
(3186, 3242, NULL, NULL, 'regulatory', NULL),
(3187, 3243, NULL, '<p class=\"MsoNormal\"><span lang=\"EN-US\">This\r\nvalidation procedure embraces all computerized and automatized systems used by\r\nprocess in the scope of Digitalis, including user interfaces and automated\r\nprocesses for data collection, data management, user accounts management and\r\nsystem administration.<o:p></o:p></span></p><p class=\"MsoNormal\"><span lang=\"EN-US\">The Digitalis\r\napplication of the system is composed of a core application, an intermediate\r\nprogramming layer for specific adaptations, and a configuration depending on\r\nthe end user requirements. The intermediate programming layer and configuration\r\nare not included in the scope of validation.<o:p></o:p></span></p><p class=\"MsoNormal\"><span lang=\"EN-US\">This is\r\ndescribed in the user requirements specifications and in the detailed\r\nfunctional specifications documents.<o:p></o:p></span></p><p class=\"MsoNormal\"><span lang=\"EN-US\">It doesn’t\r\ninclude:<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:\r\nSymbol;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;\r\n</span></span><!--[endif]--><span lang=\"EN-US\">Text\r\nor 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:\r\nSymbol;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;\r\n</span></span><!--[endif]--><span lang=\"EN-US\">Software\r\nused in processes outside scope: accounting, legal, interfaced software…<o:p></o:p></span></p><p>\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n</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:\r\nSymbol;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;\r\n</span></span><!--[endif]--><span lang=\"EN-US\" style=\"background:yellow;\r\nmso-highlight:yellow;mso-ansi-language:EN-US\">The IT infrastructure managed\r\nthrough the xxx procedure (your procedure).</span><span lang=\"EN-US\"> <o:p></o:p></span></p>', 'text_wysiwyg', NULL),
(3188, 3244, NULL, '<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\r\nDesigner:<o:p></o:p></span></a></p><p class=\"MsoListParagraphCxSpFirst\" style=\"margin-left:18.0pt;mso-add-space:\r\nauto;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;\r\n</span></span><!--[endif]--><span lang=\"EN-US\">Digitalis\r\nis the interface to manage the subjects and enter the data,<o:p></o:p></span></p><p>\r\n\r\n\r\n\r\n</p><p class=\"MsoListParagraphCxSpLast\" style=\"margin-left:18.0pt;mso-add-space:auto;\r\ntext-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;\r\n</span></span><!--[endif]--><span lang=\"EN-US\">ODM\r\nDesigner is like a back office where it is possible to design a study and its\r\nprotocol (study events, forms, items …)</span><span lang=\"EN-US\"><o:p></o:p></span></p>', 'text_wysiwyg', NULL),
(3189, 3245, NULL, '<p class=\"MsoNormal\"><span lang=\"EN-US\">Digitalis\r\nis an EDC system, a computerized system designed for the collection of clinical\r\ndata in electronic format<o:p></o:p></span></p><p>\r\n\r\n</p><p class=\"MsoNormal\"><span lang=\"EN-US\">This\r\ndocument describes the different validation steps related to Digitalis® as an\r\nEDC system that complies with 21 CFR 11, ICH GCP guidelines and is consistent\r\nwith FDA guidance on electronic systems used in clinical trials and abide CDISC\r\nstandards.<o:p></o:p></span></p>', 'text_wysiwyg', NULL),
(3190, 3246, NULL, NULL, 'glossary', NULL),
(3191, 3247, NULL, NULL, 'definition', NULL),
(3192, 3249, NULL, '<p class=\"MsoNormal\"><span lang=\"EN-US\">The eCRF\r\nsolution 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:\r\nauto;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;\r\n</span></span><!--[endif]--><span lang=\"EN-US\">Digitalis\r\nis 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:\r\nauto;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;\r\n</span></span><!--[endif]--><span lang=\"EN-US\">ODM\r\nDesigner is like a back office where it is possible to design a study and its\r\nprotocol (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\r\nDigitalis 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:\r\nSymbol;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\r\nvalidation<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:\r\nSymbol;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:\r\nSymbol;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:\r\nSymbol;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:\r\nSymbol;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;;\r\nmso-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;\r\n</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;;\r\nmso-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;\r\n</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;;\r\nmso-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;\r\n</span></span><!--[endif]--><span lang=\"EN-US\">Clinical\r\ndata<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;;\r\nmso-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;\r\n</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;;\r\nmso-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;\r\n</span></span><!--[endif]--><span lang=\"EN-US\">Study\r\ndesign<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:\r\nSymbol;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:\r\nSymbol;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\r\nforms (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:\r\nSymbol;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\r\nlist<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:\r\nSymbol;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:\r\nSymbol;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\r\nprofile<o:p></o:p></span></li></ul>', 'text_wysiwyg', NULL),
(3193, 3250, NULL, '<p class=\"MsoNormal\"><span lang=\"EN-US\">This\r\nproject is based on a system installed on a web server. This web server is a\r\ndedicated virtual machine provided by a hosting company (OVH) and physically\r\nsituated in Gravelines, France.<o:p></o:p></span></p>', 'text_wysiwyg', NULL),
(3194, 3251, NULL, '<p class=\"MsoNormal\"><span lang=\"EN-US\">The\r\ninstallation and maintenance of the physical and system environment are under\r\nthe 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\r\nownership is under the responsibility of <span style=\"color:blue\">Cerebellis\r\nGeneral Department.<o:p></o:p></span></span></p><p class=\"MsoNormal\"><span lang=\"EN-US\">The system\r\nvalidation status is under the responsibility of the business owners.</span></p><div><div><div id=\"_com_2\" class=\"msocomtxt\" language=\"JavaScript\">\r\n\r\n<!--[if !supportAnnotations]--></div>\r\n\r\n<!--[endif]--></div>\r\n\r\n</div>', 'text_wysiwyg', NULL),
(3195, 3252, NULL, '[[\"Role\",\"Identified Unit (Department/Area)\"],[\"Business Owner\",\"Cerebellis General Department\"],[\"Technical Unit\",\"Cerebellis IT Department\"],[\"Quality Unit\",\"Cerebellis Quality Department\"]]', 'free_tabl', 1),
(3196, 3253, NULL, '<p class=\"MsoNormal\"><span lang=\"EN-US\">Three\r\nseparate environments (hardware and software components) are available:<o:p></o:p></span></p><p>\r\n\r\n</p><ol style=\"margin-top:0cm\" start=\"1\" type=\"1\">\r\n <li class=\"MsoNormal\" style=\"margin-top:4.0pt;margin-bottom:0cm;margin-bottom:\r\n     .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\r\n     development. It is hosted on developer’s local virtual machines.<o:p></o:p></span></li>\r\n <li class=\"MsoNormal\" style=\"margin-top:4.0pt;margin-bottom:0cm;margin-bottom:\r\n     .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\r\n     before implementation in production environment. This environment, where\r\n     the validation testing is performed (IQ, OQ), is controlled: it is\r\n     independent, equivalent or representative of the production environment. It\r\n     also is the environment used for PQ test only once IQ and OQ phases have\r\n     been closed. It is hosted on a dedicated virtual machine provided by OVH.<o:p></o:p></span></li>\r\n <li class=\"MsoNormal\" style=\"margin-top:4.0pt;margin-bottom:0cm;margin-bottom:\r\n     .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\r\n     environment is controlled: only authorized personnel are granted access to\r\n     it. It is equivalent to the final Test/Validation and is only installed\r\n     for clients’ use. It is installed following the same process than the\r\n     qualified Test/Validation environment.<o:p></o:p></span></li>\r\n</ol>', 'text_wysiwyg', NULL),
(3197, 3255, NULL, '<p class=\"MsoNormal\"><span lang=\"EN-US\">Following\r\ntools 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:\r\nSymbol;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:\r\nissues (proposals for change: corrections, evolutions or adaptations) are\r\ntracked and managed with Mantis Bug Tracker, an open source and web-based issue\r\ntracking 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:\r\nSymbol;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:\r\nDigitalis source code is backup and stored in a code repository manage by Git,\r\nan open source version control system hosted by Cerebellis. The list of\r\nmodifications to be released are also tracked with Git.<o:p></o:p></span></li></ul>', 'text_wysiwyg', NULL),
(3198, 3256, NULL, '<p class=\"MsoNormal\"><span lang=\"EN-US\">Version\r\nnumber is stored in the source code of Digitalis in the format YY.MM[.mm] where\r\nYY stands for the year, MM for the month, and mm is optional for modifications\r\nreleased during the month if any.<o:p></o:p></span></p>', 'text_wysiwyg', NULL),
(3199, 3257, NULL, '<p class=\"MsoNormal\"><span lang=\"EN-US\">Mantis\r\nissues are selected upon development of a new version of Digitalis and\r\ncorrespond to change requests. Impact on processes and records, configuration\r\nitems and documentation are assessed collectively by Business Owner, Technical\r\nUnit and Quality Unit before acceptation of issues for the new development.\r\nAssessment details are based on business, technical and quality considerations\r\nthat are reported in Mantis for each assessed issue. Details may concern\r\nproduct management (i.e. marketing point of view), source code management (e.g.\r\ncode reviews, refactoring, components integration, etc.), and quality\r\nmanagement (e.g. conformity to existing or new regulations).<o:p></o:p></span></p><p>\r\n\r\n</p><p class=\"MsoNormal\"><span lang=\"EN-US\">Documentation,\r\ntests and eventual other impacted items (training, procedures, etc.) are\r\nupdated in accordance with implemented issues.<o:p></o:p></span></p>', 'text_wysiwyg', NULL),
(3200, 3258, NULL, '<p class=\"MsoNormal\"><a name=\"_Hlk10032548\"><span lang=\"EN-US\">The risk assessment is focused on GxP and business risks. The assessment\r\nis based on regulatory requirements, user requirements and derived functionalities.<o:p></o:p></span></a></p><p>\r\n\r\n\r\n\r\n</p><p class=\"MsoNormal\"><span lang=\"EN-US\">Based on\r\nGAMP5 classification DIGITALIS is a Category 4 system.<o:p></o:p></span></p>', 'text_wysiwyg', NULL),
(3201, 3259, NULL, '<p class=\"MsoNormal\"><span lang=\"EN-US\">The risk\r\nwill be assessed by determining an overall risk for each requirement and\r\nspecification based on a combination of risk Severity and risk Probability and\r\nrisk 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\r\nQuality, 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\"> =\r\nSeverity 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\r\nnoted before harm occurs<o:p></o:p></span></p><p class=\"MsoNormal\">\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n</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>', 'text_wysiwyg', NULL),
(3202, 3260, NULL, '<p class=\"MsoNormal\"><span lang=\"EN-US\">The risk of\r\nrequirements and functional specifications will be performed in the\r\ncorresponding deliverables (URS and FS). Each requirement and functional specification\r\nwill be assessed as described in the previous section.<o:p></o:p></span></p><p class=\"MsoNormal\"><span lang=\"EN-US\">During the\r\nQualification phases tests will be designed based on the Risk assessed to show\r\nall functionalities work as designed or that an efficient functional or\r\ntechnical 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\r\nrisk (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:\r\nCalibri;mso-fareast-font-family:Calibri;mso-hansi-font-family:Calibri;\r\nmso-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\r\nrisk (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:\r\nCalibri;mso-fareast-font-family:Calibri;mso-hansi-font-family:Calibri;\r\nmso-bidi-font-family:Calibri\">&nbsp;</span></span><span lang=\"EN-US\">with evidences if they provide\r\nadditional 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\r\nRisk (scores 6 and 9) URS and FS may be tested indirectly via testing of other\r\nfunctionalities or during PQ.<o:p></o:p></span></li></ul><p>\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n</p><div><!--[if !supportAnnotations]-->\r\n\r\n<div><div id=\"_com_1\" class=\"msocomtxt\" language=\"JavaScript\"><p class=\"MsoCommentText\"><br></p></div></div><div><div id=\"_com_4\" class=\"msocomtxt\" language=\"JavaScript\">\r\n\r\n<!--[if !supportAnnotations]--></div>\r\n\r\n<!--[endif]--></div>\r\n\r\n</div>', 'text_wysiwyg', NULL),
(3203, 3261, NULL, '<p class=\"MsoNormal\"><span lang=\"EN-US\">The\r\nvalidation strategy consists in the validation phases:<o:p></o:p></span></p><p class=\"MsoListParagraphCxSpFirst\" style=\"margin-top:4.0pt;margin-right:0cm;\r\nmargin-bottom:0cm;margin-left:36.0pt;margin-bottom:.0001pt;mso-add-space:auto;\r\ntext-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:\r\nSymbol;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;\r\n</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;\r\nmargin-bottom:0cm;margin-left:72.0pt;margin-bottom:.0001pt;mso-add-space:auto;\r\ntext-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;;\r\nmso-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;\r\n</span></span><!--[endif]--><b><span lang=\"EN-US\">User Requirements Specifications\r\n(URS): </span></b><span lang=\"EN-US\">it describes\r\nthe 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;\r\nmargin-bottom:0cm;margin-left:72.0pt;margin-bottom:.0001pt;mso-add-space:auto;\r\ntext-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;;\r\nmso-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;\r\n</span></span><!--[endif]--><b><span lang=\"EN-US\">Functional Specification (FS):</span></b><span lang=\"EN-US\"> it specifies the functions that a\r\nsystem 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;\r\nmargin-bottom:0cm;margin-left:72.0pt;margin-bottom:.0001pt;mso-add-space:auto;\r\ntext-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;;\r\nmso-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;\r\n</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\r\nvalidation project.<b><o:p></o:p></b></span></p><p class=\"MsoListParagraphCxSpMiddle\" style=\"margin-top:0cm;margin-right:0cm;\r\nmargin-bottom:0cm;margin-left:36.0pt;margin-bottom:.0001pt;mso-add-space:auto;\r\ntext-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:\r\nSymbol;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;\r\n</span></span><!--[endif]--><b><span lang=\"EN-US\">Installation Qualification (IQ):</span></b><span lang=\"EN-US\"> it describes the process that is to\r\nbe followed when installing the system in an environment. This environment may\r\nbe a testing, validation, or production environment. IQ represents the\r\ncontrols, instructions and verification steps of the successful installation\r\ninto the new environment.<o:p></o:p></span></p><p class=\"MsoListParagraphCxSpMiddle\" style=\"margin-top:0cm;margin-right:0cm;\r\nmargin-bottom:0cm;margin-left:36.0pt;margin-bottom:.0001pt;mso-add-space:auto;\r\ntext-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:\r\nSymbol;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;\r\n</span></span><!--[endif]--><b><span lang=\"EN-US\">Operational Qualification (OQ):</span></b><span lang=\"EN-US\"> it includes functionality test\r\nsteps, 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;\r\nmargin-bottom:12.0pt;margin-left:36.0pt;mso-add-space:auto;text-indent:-18.0pt;\r\nmso-list:l0 level1 lfo1\"><!--[if !supportLists]--><span lang=\"EN-US\" style=\"font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:\r\nSymbol;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;\r\n</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\r\na routine use workflow. It allows to verify that the procedures and\r\ncomputerized system work together and that routine users (with routine access\r\nlevels) can actually operate the system in a compliant manner. <o:p></o:p></span></p><p>\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n</p><p class=\"MsoNormal\" style=\"margin-top:4.0pt;margin-right:0cm;margin-bottom:12.0pt;\r\nmargin-left:0cm\"><span lang=\"EN-US\">Qualification\r\nis a systematic way of defining and verifying that the system is developed and\r\ninstalled in accordance with its specifications and is fit for purpose.<o:p></o:p></span></p>', 'text_wysiwyg', NULL),
(3204, 3262, NULL, '<ul><li style=\"text-indent: -18pt;\"><span lang=\"EN-US\" style=\"font-family:Symbol;mso-fareast-font-family:Symbol;mso-bidi-font-family:\r\nSymbol;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\r\nrequirements 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:\r\nSymbol;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\r\nlink between the requirements and the specifications developed to meet them is\r\nincluded 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:\r\nSymbol;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\r\ntest performed will be linked to the system specifications(s) by indicating the\r\nspecification(s) references(s) in regard of the test description or\r\nalternatively the test(s) reference(s) in regard of the system specification(s).<o:p></o:p></span></li></ul>', 'text_wysiwyg', NULL),
(3205, 3263, NULL, '<p class=\"MsoNormal\"><span lang=\"EN-US\">Since the\r\nsystem has already been designed, the Analysis and Design Phase will only\r\ninclude the corresponding documentation with this VP, as well as URS and FS.<o:p></o:p></span></p>', 'text_wysiwyg', NULL),
(3206, 3265, NULL, '<p class=\"MsoNormal\"><span lang=\"EN-US\">Installation\r\nqualification aims to ensure that computerized system is properly installed in\r\nthe right environment.<o:p></o:p></span></p><p class=\"MsoNormal\"><span lang=\"EN-US\">The scope\r\nof 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:\r\nSymbol;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;\r\n</span></span><!--[endif]--><span lang=\"EN-US\">As\r\nthe 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;;\r\nmso-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;\r\n</span></span><!--[endif]--><span lang=\"EN-US\">Cloud\r\nservers 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;;\r\nmso-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;\r\n</span></span><!--[endif]--><span lang=\"EN-US\">Contract\r\nwith 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:\r\nSymbol;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;\r\n</span></span><!--[endif]--><span lang=\"EN-US\">Verifying\r\nthat software environment settings and characteristics match environment\r\nrequirements:<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;;\r\nmso-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;\r\n</span></span><!--[endif]--><span lang=\"EN-US\">Operating\r\nsystem 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;;\r\nmso-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;\r\n</span></span><!--[endif]--><span lang=\"EN-US\">Server\r\nweb 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:\r\nSymbol;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;\r\n</span></span><!--[endif]--><span lang=\"EN-US\">Verifying\r\nthat 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;;\r\nmso-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;\r\n</span></span><!--[endif]--><span lang=\"EN-US\">Installation,\r\nadministration 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:\r\nSymbol;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;\r\n</span></span><!--[endif]--><span lang=\"EN-US\">Installing\r\nsoftware, 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:\r\nSymbol;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;\r\n</span></span><!--[endif]--><span lang=\"EN-US\">Verifying\r\nthat 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;;\r\nmso-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;\r\n</span></span><!--[endif]--><span lang=\"EN-US\">Software\r\nversion,<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;;\r\nmso-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;\r\n</span></span><!--[endif]--><span lang=\"EN-US\">Installation\r\nresults 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:\r\nSymbol;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;\r\n</span></span><!--[endif]--><span lang=\"EN-US\">Configuring\r\nsoftware,<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:\r\nSymbol;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;\r\n</span></span><!--[endif]--><span lang=\"EN-US\">Verifying\r\nthat 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;;\r\nmso-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;\r\n</span></span><!--[endif]--><span lang=\"EN-US\">Configuration\r\nsettings,<o:p></o:p></span></p><p>\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n</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;;\r\nmso-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;\r\n</span></span><!--[endif]--><span lang=\"EN-US\">Configuration\r\nsteps logs.<o:p></o:p></span></p>', 'text_wysiwyg', NULL),
(3207, 3266, NULL, '<p class=\"MsoNormal\"><span lang=\"EN-US\">The\r\ninstallation 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:\r\nSymbol;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;\r\n</span></span><!--[endif]--><span lang=\"EN-US\">An\r\ninstallation qualification protocol containing all the verification/inspections\r\nrequired,<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:\r\nSymbol;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;\r\n</span></span><!--[endif]--><span lang=\"EN-US\">One\r\nor more installation qualification reports containing results of installation\r\nqualification,<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:\r\nSymbol;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;\r\n</span></span><!--[endif]--><span lang=\"EN-US\">Any\r\nadditional record serving as evidence of installation qualification,<o:p></o:p></span></p><p>\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n</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:\r\nSymbol;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;\r\n</span></span><!--[endif]--><span lang=\"EN-US\">Bug\r\nreports found during installation qualification.<o:p></o:p></span></p>', 'text_wysiwyg', NULL);
INSERT INTO `csv_software_content` (`id`, `id_chapter`, `title`, `content`, `type`, `row`) VALUES
(3208, 3268, NULL, '<p class=\"MsoNormal\"><span lang=\"EN-US\">Operational\r\nqualification aims to ensure that every function of the computerized system is\r\nworking as expected.<o:p></o:p></span></p><p class=\"MsoNormal\"><span lang=\"EN-US\">The scope\r\nof 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:\r\nSymbol;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;\r\n</span></span><!--[endif]--><span lang=\"EN-US\">Functional\r\nand 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;;\r\nmso-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;\r\n</span></span><!--[endif]--><span lang=\"EN-US\">Verifying\r\nsoftware 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;;\r\nmso-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;\r\n</span></span><!--[endif]--><span lang=\"EN-US\">Security,\r\nsafety 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:\r\nSymbol;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;\r\n</span></span><!--[endif]--><span lang=\"EN-US\">Non-functional\r\nrequirements, 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;;\r\nmso-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;\r\n</span></span><!--[endif]--><span lang=\"EN-US\">Administration\r\nfunctions,<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;;\r\nmso-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;\r\n</span></span><!--[endif]--><span lang=\"EN-US\">Maintenance\r\nfunctions,<o:p></o:p></span></p><p>\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n</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;;\r\nmso-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;\r\n</span></span><!--[endif]--><span lang=\"EN-US\">21\r\nPart 11 compliance.<o:p></o:p></span></p>', 'text_wysiwyg', NULL),
(3209, 3269, NULL, '<p class=\"MsoNormal\"><span lang=\"EN-US\">The\r\nperformance 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:\r\nSymbol;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;\r\n</span></span><!--[endif]--><span lang=\"EN-US\">Optionally,\r\na performance qualification protocol containing verifications of user\r\nrequirements,<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:\r\nSymbol;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;\r\n</span></span><!--[endif]--><span lang=\"EN-US\">One\r\nor more performance qualification reports containing feedback of users,\r\ndiscovered 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:\r\nSymbol;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;\r\n</span></span><!--[endif]--><span lang=\"EN-US\">Optionally,\r\nany record serving as evidence of performance qualification,<o:p></o:p></span></p><p>\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n</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:\r\nSymbol;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;\r\n</span></span><!--[endif]--><span lang=\"EN-US\">Bug\r\nreports found during performance qualification.<o:p></o:p></span></p>', 'text_wysiwyg', NULL),
(3210, 3271, NULL, '<p class=\"MsoNormal\"><span lang=\"EN-US\">Deviations\r\nand software bugs are recorded in Mantis Bug Tracker.<o:p></o:p></span></p><p class=\"MsoNormal\"><span lang=\"EN-US\">The\r\nseverity 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:\r\nSymbol;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;\r\n</span></span><!--[endif]--><span lang=\"EN-US\">Major:\r\nmajor 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:\r\nSymbol;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;\r\n</span></span><!--[endif]--><span lang=\"EN-US\">Medium:\r\nnon-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:\r\nSymbol;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;\r\n</span></span><!--[endif]--><span lang=\"EN-US\">Minor:\r\nNo 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\r\nof 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:\r\nSymbol;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;\r\n</span></span><!--[endif]--><span lang=\"EN-US\">High:\r\nresolution 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:\r\nSymbol;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;\r\n</span></span><!--[endif]--><span lang=\"EN-US\">Normal:\r\nresolution 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:\r\nSymbol;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;\r\n</span></span><!--[endif]--><span lang=\"EN-US\">Low:\r\nresolution 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\r\nresponsibilities 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:\r\nSymbol;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;\r\n</span></span><!--[endif]--><span lang=\"EN-US\">Technical\r\nUnit, 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:\r\nSymbol;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;\r\n</span></span><!--[endif]--><span lang=\"EN-US\">Technical\r\nUnit describes the technical analyses of the root cause of the deviation,\r\nproposes 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:\r\nSymbol;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;\r\n</span></span><!--[endif]--><span lang=\"EN-US\">Business\r\nOwner 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\r\naction should include, where applicable, revision of requirements and\r\nspecifications, version changes to software, and re-testing.<o:p></o:p></span></p><p>\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n</p><p class=\"MsoNormal\"><span lang=\"EN-US\">All\r\nincidents must be analyzed and reviewed by QA.<o:p></o:p></span></p>', 'text_wysiwyg', NULL),
(3211, 3272, NULL, '<p class=\"MsoNormal\"><span lang=\"EN-US\">Deviations\r\nduring qualification testing like anomalies, incident and non-conformity\r\nreports or log, must be reviewed by the Business Responsible who will decide\r\nwhat should be done (amendment to this plan, further steps, amendments to\r\nprotocols, etc.).<o:p></o:p></span></p><p>\r\n\r\n</p><p class=\"MsoNormal\"><span lang=\"EN-US\">Deviations\r\nfrom validation plan will be listed, and justified/explained in the validation\r\nreport.<o:p></o:p></span></p>', 'text_wysiwyg', NULL),
(3212, 3274, NULL, '<p class=\"MsoNormal\"><span lang=\"EN-US\">Reports are\r\nrequired to summarize each of the qualification phases of the validation\r\nproject.&nbsp; <o:p></o:p></span></p><p class=\"MsoNormal\"><span lang=\"EN-US\">All\r\nqualification 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:\r\nSymbol;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;\r\n</span></span><!--[endif]--><span lang=\"EN-US\">An\r\noverall 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:\r\nSymbol;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;\r\n</span></span><!--[endif]--><span lang=\"EN-US\">Inclusion\r\nor reference of the location of the qualification documentation (approved and executed\r\ntests 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:\r\nSymbol;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;\r\n</span></span><!--[endif]--><span lang=\"EN-US\">Discussion\r\nof all deviations, corrective actions, and resulting changes (especially bug\r\nfixes between IQ and OQ or OQ and PQ)<o:p></o:p></span></p><p>\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n</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:\r\nSymbol;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;\r\n</span></span><!--[endif]--><span lang=\"EN-US\">A\r\nconclusion that includes conditions for use of the system.<o:p></o:p></span></p>', 'text_wysiwyg', NULL),
(3213, 3275, NULL, '<p class=\"MsoNormal\"><span lang=\"EN-US\">Successful\r\ncompletion of IQ as shown in the IQ report (with conditions if any) will allow\r\nto perform OQ.<o:p></o:p></span></p><p class=\"MsoNormal\"><span lang=\"EN-US\">OQ\r\ncompletion will be summarized in the OQ report which will allow to move on to\r\nPQ (with conditions if any).<o:p></o:p></span></p><p class=\"MsoNormal\"><span lang=\"EN-US\">IQ, OQ and\r\nPQ phases can be summarized in an intermediary Validation Report to allow\r\nrelease 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\r\nphase will be carried out before the final Validation Report can be issued\r\n(again if an intermediary Validation Report was issued).<o:p></o:p></span></p><p>\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n</p><p class=\"MsoNormal\"><span lang=\"EN-US\">A list of\r\nall anomalies which were detected during each qualification phase will be\r\nincluded in each qualification and validation report. Corrective measures and\r\nclosure of all anomalies is required before issuing the Final Validation\r\nReport.<o:p></o:p></span></p>', 'text_wysiwyg', NULL),
(3214, 3276, NULL, '<p class=\"MsoNormal\"><span lang=\"EN-US\">If any\r\nanomaly remains open the system may be approved for use under certain\r\nconditions. These anomalies and acceptance conditions must be explained in the\r\nValidation Report that will remain as an Intermediary Validation Report until\r\nthey are all cleared.<o:p></o:p></span></p>', 'text_wysiwyg', NULL),
(3215, 3277, NULL, '<p class=\"MsoNormal\"><span lang=\"EN-US\">Once all\r\nanomalies have been closed or after a significant period of operational use,\r\nthe validation status of the system is re-evaluated in terms of the acceptance\r\ncriteria to provide the Validated status to the system. This is summarized in\r\nthe Final Validation Report.<o:p></o:p></span></p>', 'text_wysiwyg', NULL),
(3216, 3278, NULL, '<p class=\"MsoNormal\"><span lang=\"EN-US\">A\r\nValidation Report is required to verify the completion of all activities\r\nrequired by the validation protocol.<o:p></o:p></span></p><p class=\"MsoNormal\"><span lang=\"EN-US\">The\r\nvalidation 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:\r\nSymbol;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;\r\n</span></span><!--[endif]--><span lang=\"EN-US\">An\r\noverall 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:\r\nSymbol;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;\r\n</span></span><!--[endif]--><span lang=\"EN-US\">A\r\nlist of all deliverables generated as per the Validation Plan and their\r\nlocation,<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:\r\nSymbol;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;\r\n</span></span><!--[endif]--><span lang=\"EN-US\">Any\r\ndeviation from the Validation Plan with justification,<o:p></o:p></span></p><p>\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n</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:\r\nSymbol;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;\r\n</span></span><!--[endif]--><span lang=\"EN-US\">A\r\nclear conclusion based on the acceptance criteria here below indicating whether\r\nor not the system is suitable for use in routine operations.<o:p></o:p></span></p>', 'text_wysiwyg', NULL),
(3217, 3279, 'Acceptance criteria table', '[[\"Acceptance Criteria ID\",\"Acceptance Criteria Description\"],[\"AC-1\",\"The system functionalities comply with user requirements and the regulations (approved documentation and qualifications performed).\"],[\"AC-2\",\"There are no malfunctions with the system functionalities (no open non-conformity)\"],[\"AC-3\",\"The system is available and operates adequately in use (successful PQ).\"],[\"AC-4\",\"The validation steps and deliverables comply with the Validation Plan (with deviations from VP well justified if any).\"]]', 'free_tabl', 1),
(3218, 3280, NULL, '<p class=\"MsoNormal\"><span lang=\"EN-US\">Each\r\ncriterion is checked according to the following scale:<o:p></o:p></span></p><p class=\"MsoListParagraphCxSpFirst\" style=\"margin-bottom:0cm;margin-bottom:.0001pt;\r\nmso-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:\r\nSymbol;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;\r\n</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;\r\nmargin-bottom:0cm;margin-left:36.0pt;margin-bottom:.0001pt;mso-add-space:auto;\r\ntext-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:\r\nSymbol;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;\r\n</span></span><!--[endif]--><i><span lang=\"EN-US\">Non-Compliant</span></i><span lang=\"EN-US\"> (NC): anomalies have been reported\r\nand the process of system implementation must then be deferred until they have\r\nbeen cleared up.<o:p></o:p></span></p><p class=\"MsoListParagraphCxSpLast\" style=\"margin-top:0cm;margin-right:0cm;\r\nmargin-bottom:0cm;margin-left:36.0pt;margin-bottom:.0001pt;mso-add-space:auto;\r\ntext-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:\r\nSymbol;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;\r\n</span></span><!--[endif]--><i><span lang=\"EN-US\">Non-Compliant but Accepted with\r\nconditions</span></i><span lang=\"EN-US\"> (CAC):\r\nanomalies have been reported but are not blocking, corrective measures and/or\r\nwork-arounds have been defined (see section 6.4 Conditional Acceptance).<o:p></o:p></span></p><p class=\"MsoNormal\"><span lang=\"EN-US\">The\r\nvalidation status of the system corresponds to the lowest level of compliance\r\nof the 4 criteria listed above.<o:p></o:p></span></p><p class=\"MsoNormal\"><span lang=\"EN-US\">This\r\nevaluation, as well as the list of anomalies detected at the time of\r\nqualification or in production, and not cleared up after validation, is\r\npresented in the Validation Report.<o:p></o:p></span></p><p>\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n</p><p class=\"MsoNormal\"><span lang=\"EN-US\">On the\r\nbasis of these results, the<span style=\"color:red\"> </span>Business owner/\r\nProcess Owner and the System Owner finally gives permission for the system to be\r\nused and record their decision by approving the Validation Report.<o:p></o:p></span></p>', 'text_wysiwyg', NULL),
(3219, 3282, NULL, '[[\"Role\",\"Responsibilities\",\"Name, function / company\",\"Project\",\"Operation\"],[\"Process Owner\",\"•\\tWrites and/or reviews URS •\\tWrites and/or reviews FS in relation to the URS •\\tWrites and/or supports writing of qualifications protocols •\\tSupports qualification tests execution •\\tRunning tests for system changes •\\tKey User Training\",\"Cerebellis, Thomas Perraudin\",\"x\",\"x\"],[\"Business Responsible\",\"•\\tCarries out project management •\\tPerform CSV documentation maintenance or allocates resources to do so •\\tUser Training\",\"Cerebellis, Thomas Perraudin\",\"x\",\"\"],[\"Key User\",\"•\\tTrained to use the system •\\tExecute qualification tests protocols\",\"\",\"x\",\"\"],[\"Technical Unit\",\"•\\tTechnical support (installation and functionalities) if necessary •\\tWrites or supports writing of FS •\\tWrites and/or reviews qualification protocols •\\tSupport during qualifications / reviews anomalies •\\tEstablishment of infrastructure during the project and operational phases •\\tAssistance with setting up the system during the project •\\tRealization of system changes in accordance with the Functional Specifications •\\tUser Training  •\\tUser support during the production phase\",\"Cerebellis, Laurent Noyon\",\"x\",\"x\"],[\"CSV\",\"•\\tWriting Validation Plan and Report •\\tSupport and review for most qualification documents including o\\tURS and FS (regarding risk analysis and regulatory compliance) o\\tIQ, OQ, PQ protocols (preparation and execution review)\",\"Writee, Marie Euzen\",\"x\",\"\"],[\"QA\",\"•\\tResponsible for Quality Assurance and regulatory support during the project phase •\\tReview and approval of Procedure if any •\\tReview and Approval of Validation Documents •\\tReview validation anomalies if needed •\\tReview and approval of changes during initial validation\",\"Writee, Marie Euzen\",\"x\",\"\"],[\"QA\",\"•\\tResponsible for Quality Assurance and regulatory support during the operational phase •\\tReview and approval of Procedure if any •\\tValidation anomalies review if needed\",\"Cerebellis, Thomas Perraudin\",\"\",\"x\"]]', 'free_tabl', 1),
(3220, 3283, NULL, '<p class=\"MsoNormal\"><span lang=\"EN-US\">The list of\r\ndeliverables for the validation of Digitalis is summarized in the matrix below,\r\nwith 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:\r\nSymbol;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\r\ntask completion within his area of expertise. There may be multiple Responsible\r\nfor 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:\r\nSymbol;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\r\ntask completion. He may be responsible in his area of expertise. There is one\r\nand only one Accountable for each task. The accountable is a mandatory approver\r\nof 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:\r\nSymbol;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\r\nbe consulted by the Accountable or any Responsible prior to the task completion\r\nand/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:\r\nSymbol;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\r\nthe task completion.<o:p></o:p></span></li></ul>', 'text_wysiwyg', NULL),
(3221, 3284, NULL, '[[\"Delivrable\",\"Process Owner\",\"Business Responsible\",\"Key User\",\"Technical Unit\",\"CSV\",\"QA\"],[\"Analysis /Design Phase\",\"Analysis /Design Phase\",\"Analysis /Design Phase\",\"Analysis /Design Phase\",\"Analysis /Design Phase\",\"Analysis /Design Phase\",\"Analysis /Design Phase\"],[\"User Requirement Specification (URS)\",\"A\",\"C\",\"-\",\"R\",\"R\",\"R\"],[\"Validation Plan (VP)\",\"R\",\"C\",\"-\",\"R\",\"R\",\"A\"],[\"Functional Specification (FS)\",\"A\",\"C\",\"-\",\"R\",\"R\",\"R\"],[\"Testing\",\"Testing\",\"Testing\",\"Testing\",\"Testing\",\"Testing\",\"Testing\"],[\"IQ Protocol & Report \",\"R\",\"I\",\"I\",\"A\",\"R\",\"R\"],[\"IQ Execution\",\"I\",\"I\",\"A\",\"R\",\"R\",\"R\"],[\"OQ Protocol & Report\",\"A\",\"I\",\"I\",\"R\",\"R\",\"R\"],[\"OQ Execution\",\"I\",\"I\",\"A\",\"R\",\"R\",\"R\"],[\"Implementation\",\"Implementation\",\"Implementation\",\"Implementation\",\"Implementation\",\"Implementation\",\"Implementation\"],[\"PQ Protocol & Report\",\"A\",\"I\",\"I\",\"R\",\"R\",\"R\"],[\"PQ Execution\",\"R\",\"C\",\"A\",\"I\",\"R\",\"R\"],[\"Validation Report\",\"R\",\"C\",\"-\",\"R\",\"R\",\"A\"]]', 'free_tabl', 1),
(3222, 3285, NULL, '<p class=\"MsoNormal\"><span lang=\"EN-US\">Digitalis-User\r\nRequirements Specification-<span style=\"background:yellow;mso-highlight:yellow\">version\r\n1</span>.0<o:p></o:p></span></p>', 'text_wysiwyg', NULL);

-- --------------------------------------------------------

--
-- Structure de la table `csv_software_definition`
--

CREATE TABLE IF NOT EXISTS `csv_software_definition` (
  `id` int(11) NOT NULL AUTO_INCREMENT,
  `term` varchar(255) NOT NULL,
  `definition` text NOT NULL,
  `id_project` int(255) NOT NULL,
  PRIMARY KEY (`id`)
) ENGINE=MyISAM AUTO_INCREMENT=41 DEFAULT CHARSET=utf8;

--
-- Déchargement des données de la table `csv_software_definition`
--

INSERT INTO `csv_software_definition` (`id`, `term`, `definition`, `id_project`) VALUES
(36, 'CAPA', 'Set of actions to take in documentation, procedures, or systems to rectify and eliminate non-conformities.', 40),
(37, 'ECRF', 'Electronic forms dedicated to clinical data collection.', 40),
(38, 'EDC', 'Computerized system designed for the collection of clinical data in electronic format.', 40),
(39, 'ODM', '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.', 40),
(40, 'SOP', '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.', 40);

-- --------------------------------------------------------

--
-- Structure de la table `csv_software_document`
--

CREATE TABLE IF NOT EXISTS `csv_software_document` (
  `id` int(11) NOT NULL AUTO_INCREMENT,
  `id_project` int(11) NOT NULL,
  `name` varchar(255) NOT NULL,
  `key_doc` varchar(255) NOT NULL,
  `plan` text DEFAULT NULL,
  `test_report` int(1) NOT NULL,
  `comment` text,
  `validated` tinyint(1) NOT NULL,
  `version` int(11) NOT NULL,
  `reason` text NOT NULL,
  `date_validation` datetime DEFAULT NULL,
  `id_glossary` varchar(255) DEFAULT NULL,
  `id_regulatory` varchar(255) DEFAULT NULL,
  `id_definition` varchar(255) DEFAULT NULL,
  PRIMARY KEY (`id`)
) ENGINE=MyISAM AUTO_INCREMENT=454 DEFAULT CHARSET=utf8;

--
-- Déchargement des données de la table `csv_software_document`
--

INSERT INTO `csv_software_document` (`id`, `id_project`, `name`, `key_doc`, `plan`, `test_report`, `comment`, `validated`, `version`, `reason`, `date_validation`, `id_glossary`, `id_regulatory`, `id_definition`) VALUES
(444, 40, 'Validation Plan', 'VP40', '[{\"id\": 3239, \"children\": [{\"id\": 3240}, {\"id\": 3241, \"children\": [{\"id\": 3242}, {\"id\": 3243}]}, {\"id\": 3244}]}, {\"id\": 3245, \"children\": [{\"id\": 3246}, {\"id\": 3247}]}, {\"id\": 3248, \"children\": [{\"id\": 3249}, {\"id\": 3250}, {\"id\": 3251}, {\"id\": 3252}, {\"id\": 3253}, {\"id\": 3254, \"children\": [{\"id\": 3255}, {\"id\": 3256}, {\"id\": 3257}]}]}, {\"id\": 3258, \"children\": [{\"id\": 3259}, {\"id\": 3260}]}, {\"id\": 3261, \"children\": [{\"id\": 3262}, {\"id\": 3263}, {\"id\": 3264, \"children\": [{\"id\": 3265}, {\"id\": 3266}]}, {\"id\": 3267, \"children\": [{\"id\": 3268}, {\"id\": 3269}]}, {\"id\": 3270, \"children\": [{\"id\": 3271}, {\"id\": 3272}]}]}, {\"id\": 3273, \"children\": [{\"id\": 3274}, {\"id\": 3275}, {\"id\": 3276}, {\"id\": 3277}, {\"id\": 3278}, {\"id\": 3279}, {\"id\": 3280}]}, {\"id\": 3281, \"children\": [{\"id\": 3282}, {\"id\": 3283}, {\"id\": 3284}]}, {\"id\": 3285}]', 0, NULL, 1, 1, 'first release', '2019-08-30 09:46:38', '217,218,219,220,221,222,223,224,225,226,227,228,229,230,231,232,233,234', '73,74,75,76,77', ',36,37,38,39,40');

-- --------------------------------------------------------

--
-- Structure de la table `csv_software_functionnality`
--

CREATE TABLE IF NOT EXISTS `csv_software_functionnality` (
  `id` int(11) NOT NULL AUTO_INCREMENT,
  `code` varchar(255) NOT NULL,
  `description` text NOT NULL,
  `risk_class` varchar(20) NOT NULL,
  `id_project` int(11) NOT NULL,
  `urs` varchar(255) DEFAULT NULL,
  `id_chapter` int(11) NOT NULL,
  `detectability` varchar(20) NOT NULL,
  `FS_risk` varchar(20) NOT NULL,
  PRIMARY KEY (`id`)
) ENGINE=MyISAM AUTO_INCREMENT=363 DEFAULT CHARSET=utf8;

-- --------------------------------------------------------

--
-- Structure de la table `csv_software_glossary`
--

CREATE TABLE IF NOT EXISTS `csv_software_glossary` (
  `id` int(11) NOT NULL AUTO_INCREMENT,
  `word` varchar(20) NOT NULL,
  `definition` varchar(255) NOT NULL,
  `id_project` int(11) NOT NULL,
  PRIMARY KEY (`id`)
) ENGINE=MyISAM AUTO_INCREMENT=235 DEFAULT CHARSET=utf8;

--
-- Déchargement des données de la table `csv_software_glossary`
--

INSERT INTO `csv_software_glossary` (`id`, `word`, `definition`, `id_project`) VALUES
(217, 'CAPA', 'Corrective Action and Preventive Action', 40),
(218, 'CFR', 'Code of Federal Regulation', 40),
(219, 'CSV', 'Computer System Validation', 40),
(220, 'ECRF', 'electronic Case Report Form', 40),
(221, 'EDC', 'Electronic Data Capture', 40),
(222, 'ICH', 'International Conference on Harmonisation', 40),
(223, 'FDA', 'Food and Drugs Administration', 40),
(224, 'FS', 'Functional Specifications', 40),
(225, 'GAMP', 'Good Automated Manufacturing Practices', 40),
(226, 'IQ', 'Installation Qualification', 40),
(227, 'IT', 'Information Technology', 40),
(228, 'ODM', 'Operational Data Model', 40),
(229, 'OQ', 'Operational Qualification', 40),
(230, 'PQ', 'Performance Qualification', 40),
(231, 'QA', 'Quality Assurance', 40),
(232, 'SOP', 'Standard Operating Procedure', 40),
(233, 'URS', 'User Requirements Specifications', 40),
(234, 'VP', 'Validation Plan', 40);

-- --------------------------------------------------------

--
-- Structure de la table `csv_software_image`
--

CREATE TABLE IF NOT EXISTS `csv_software_image` (
  `id` int(11) NOT NULL AUTO_INCREMENT,
  `filename` varchar(150) NOT NULL,
  PRIMARY KEY (`id`)
) ENGINE=MyISAM AUTO_INCREMENT=53 DEFAULT CHARSET=utf8;

--
-- Déchargement des données de la table `csv_software_image`
--

INSERT INTO `csv_software_image` (`id`, `filename`) VALUES
(52, 'risque.png');

-- --------------------------------------------------------

--
-- Structure de la table `csv_software_incident`
--

CREATE TABLE IF NOT EXISTS `csv_software_incident` (
  `id` int(11) NOT NULL AUTO_INCREMENT,
  `version` int(255) NOT NULL,
  `code` varchar(255) NOT NULL,
  `record_date` date NOT NULL,
  `originator` int(255) DEFAULT NULL,
  `initiated_by` varchar(255) NOT NULL,
  `quality_alert` varchar(255) DEFAULT NULL,
  `conformity_alert` varchar(255) DEFAULT NULL,
  `justification` text,
  `incident_details` text NOT NULL,
  `system_affected` varchar(255) NOT NULL,
  `system_version` varchar(255) NOT NULL,
  `priority` varchar(255) NOT NULL,
  `test_date` date DEFAULT NULL,
  `resolved_recorded` int(255) DEFAULT NULL,
  `resolution_details` text,
  `proposed_by` varchar(255) DEFAULT NULL,
  `approved_by` varchar(255) DEFAULT NULL,
  `closed_by` int(255) DEFAULT NULL,
  `closure` varchar(255) NOT NULL,
  `date_closure` date DEFAULT NULL,
  `id_project` int(255) NOT NULL,
  PRIMARY KEY (`id`)
) ENGINE=MyISAM AUTO_INCREMENT=92 DEFAULT CHARSET=utf8;

-- --------------------------------------------------------

--
-- Structure de la table `csv_software_parameters`
--

CREATE TABLE IF NOT EXISTS `csv_software_parameters` (
  `id` int(11) NOT NULL AUTO_INCREMENT,
  `name` varchar(255) NOT NULL,
  `value` varchar(255) NOT NULL,
  `id_test` int(255) NOT NULL,
  PRIMARY KEY (`id`)
) ENGINE=MyISAM AUTO_INCREMENT=97 DEFAULT CHARSET=utf8;

-- --------------------------------------------------------

--
-- Structure de la table `csv_software_project`
--

CREATE TABLE IF NOT EXISTS `csv_software_project` (
  `id` int(11) NOT NULL AUTO_INCREMENT,
  `name` varchar(50) NOT NULL,
  `acronym` varchar(20) NOT NULL,
  `risk` varchar(20) NOT NULL,
  `name_rtm` varchar(255) DEFAULT NULL,
  `tests` int(1) DEFAULT NULL,
  `signature` int(1) NOT NULL,
  `beginning_test` date DEFAULT NULL,
  `ending_test` date DEFAULT NULL,
  PRIMARY KEY (`id`)
) ENGINE=MyISAM AUTO_INCREMENT=44 DEFAULT CHARSET=utf8;

--
-- Déchargement des données de la table `csv_software_project`
--

INSERT INTO `csv_software_project` (`id`, `name`, `acronym`, `risk`, `name_rtm`, `tests`, `signature`, `beginning_test`, `ending_test`) VALUES
(40, 'Digitalis', 'DI', 'risk1-9', NULL, 0, 0, NULL, NULL);

-- --------------------------------------------------------

--
-- Structure de la table `csv_software_regulatory`
--

CREATE TABLE IF NOT EXISTS `csv_software_regulatory` (
  `id` int(11) NOT NULL AUTO_INCREMENT,
  `regulation` varchar(255) NOT NULL,
  `description` text NOT NULL,
  `id_project` int(11) NOT NULL,
  PRIMARY KEY (`id`)
) ENGINE=MyISAM AUTO_INCREMENT=78 DEFAULT CHARSET=utf8;

--
-- Déchargement des données de la table `csv_software_regulatory`
--

INSERT INTO `csv_software_regulatory` (`id`, `regulation`, `description`, `id_project`) VALUES
(73, 'CE Regulation and European directive', 'EudraLex Volume 4 – Annex 11 « Computerised Systems » and Annex 15 « Qualification and Validation »', 40),
(74, 'ICH Topic E6', 'International Conference on Harmonization - Guideline for Good Clinical Practices', 40),
(75, 'FDA 21 CFR (Code of Federal Regulations) Part 11', 'Electronic Records, Electronic Signatures – Final Rule', 40),
(76, 'GAMP5', 'A Risk-based Approach to Compliant GxP Computerised Systems', 40),
(77, 'PIC/S Guidance (PI011)', 'Good Practices for Computerised Systems in Regulated « GXP » Environments', 40);

-- --------------------------------------------------------

--
-- Structure de la table `csv_software_signature`
--

CREATE TABLE IF NOT EXISTS `csv_software_signature` (
  `id` int(11) NOT NULL AUTO_INCREMENT,
  `identity` varchar(255) NOT NULL,
  `date_of` date DEFAULT NULL,
  `role` varchar(255) NOT NULL,
  `department` varchar(255) NOT NULL,
  `meaning_of` text,
  `id_document` int(255) DEFAULT NULL,
  `id_test` int(255) DEFAULT NULL,
  `rtm` int(255) DEFAULT NULL,
  PRIMARY KEY (`id`)
) ENGINE=MyISAM AUTO_INCREMENT=1127 DEFAULT CHARSET=utf8;

--
-- Déchargement des données de la table `csv_software_signature`
--

INSERT INTO `csv_software_signature` (`id`, `identity`, `date_of`, `role`, `department`, `meaning_of`, `id_document`, `id_test`, `rtm`) VALUES
(1101, 'Euzen Marie', NULL, 'redactor', 'Computer System Validation Specialist', 'I confirm that the execution of the plan will produce a system compliant with applicable procedures and regulations.', 444, NULL, NULL),
(1102, 'Pucheu Marion ', NULL, 'review', 'Process Owner', 'I confirm that the validation plan includes all activities and deliverables suitable for managing quality on this project. \r\nI will execute this plan according to my responsibility, delivering a system fit for supporting business processes.\r\n', 444, NULL, NULL),
(1103, 'Noyon Laurent', NULL, 'review', 'Technical Unit', 'I confirm that the validation plan includes all activities and deliverables suitable for managing quality on this project.  \r\nI will execute this plan according to my responsibility, delivering a system fit for technical processes.\r\n', 444, NULL, NULL),
(1104, 'Perraudin Thomas', NULL, 'approvor', 'Business Responsible', 'I confirm that the validation plan includes all activities and deliverables suitable for managing quality on this project. \r\nI confirm that the execution of the plan will produce a system compliant with applicable procedures and regulations.  \r\n', 444, NULL, NULL),
(1105, 'Euzen Marie', NULL, 'redactor', 'Computer System Validation Specialist', 'I confirm that the execution of the plan will produce a system compliant with applicable procedures and regulations.', 445, NULL, NULL),
(1106, 'Noyon Laurent', NULL, 'review', 'Technical Unit', 'I confirm that the validation plan includes all activities and deliverables suitable for managing quality on this project.  \r\nI will execute this plan according to my responsibility, delivering a system fit for technical processes.\r\n', 445, NULL, NULL),
(1107, 'Perraudin Thomas', NULL, 'approvor', 'Business Responsible', 'I confirm that the validation plan includes all activities and deliverables suitable for managing quality on this project. \r\nI confirm that the execution of the plan will produce a system compliant with applicable procedures and regulations.  \r\n', 445, NULL, NULL),
(1108, 'Pucheu Marion ', NULL, 'review', 'Process Owner', 'I confirm that the validation plan includes all activities and deliverables suitable for managing quality on this project. \r\nI will execute this plan according to my responsibility, delivering a system fit for supporting business processes.\r\n', 445, NULL, NULL),
(1109, 'Euzen Marie', NULL, 'redactor', 'Computer System Validation Specialist', 'I confirm that the execution of the plan will produce a system compliant with applicable procedures and regulations.', 446, NULL, NULL),
(1110, 'Noyon Laurent', NULL, 'review', 'Technical Unit', 'I confirm that the validation plan includes all activities and deliverables suitable for managing quality on this project.  \r\nI will execute this plan according to my responsibility, delivering a system fit for technical processes.\r\n', 446, NULL, NULL),
(1111, 'Perraudin Thomas', NULL, 'approvor', 'Business Responsible', 'I confirm that the validation plan includes all activities and deliverables suitable for managing quality on this project. \r\nI confirm that the execution of the plan will produce a system compliant with applicable procedures and regulations.  \r\n', 446, NULL, NULL),
(1112, 'Pucheu Marion ', NULL, 'review', 'Process Owner', 'I confirm that the validation plan includes all activities and deliverables suitable for managing quality on this project. \r\nI will execute this plan according to my responsibility, delivering a system fit for supporting business processes.\r\n', 446, NULL, NULL),
(1113, 'Euzen Marie', NULL, 'redactor', 'Computer System Validation Specialist', 'I confirm that the execution of the plan will produce a system compliant with applicable procedures and regulations.', 447, NULL, NULL),
(1114, 'Noyon Laurent', NULL, 'review', 'Technical Unit', 'I confirm that the validation plan includes all activities and deliverables suitable for managing quality on this project.  \r\nI will execute this plan according to my responsibility, delivering a system fit for technical processes.\r\n', 447, NULL, NULL),
(1115, 'Perraudin Thomas', NULL, 'approvor', 'Business Responsible', 'I confirm that the validation plan includes all activities and deliverables suitable for managing quality on this project. \r\nI confirm that the execution of the plan will produce a system compliant with applicable procedures and regulations.  \r\n', 447, NULL, NULL),
(1116, 'Pucheu Marion ', NULL, 'review', 'Process Owner', 'I confirm that the validation plan includes all activities and deliverables suitable for managing quality on this project. \r\nI will execute this plan according to my responsibility, delivering a system fit for supporting business processes.\r\n', 447, NULL, NULL),
(1119, 'Euzen Marie', NULL, 'redactor', 'Computer System Validation Specialist', 'I confirm that the execution of the plan will produce a system compliant with applicable procedures and regulations.', 448, NULL, NULL),
(1120, 'Noyon Laurent', NULL, 'review', 'Technical Unit', 'I confirm that the validation plan includes all activities and deliverables suitable for managing quality on this project.  \r\nI will execute this plan according to my responsibility, delivering a system fit for technical processes.\r\n', 448, NULL, NULL),
(1121, 'Perraudin Thomas', NULL, 'approvor', 'Business Responsible', 'I confirm that the validation plan includes all activities and deliverables suitable for managing quality on this project. \r\nI confirm that the execution of the plan will produce a system compliant with applicable procedures and regulations.  \r\n', 448, NULL, NULL),
(1122, 'Pucheu Marion ', NULL, 'review', 'Process Owner', 'I confirm that the validation plan includes all activities and deliverables suitable for managing quality on this project. \r\nI will execute this plan according to my responsibility, delivering a system fit for supporting business processes.\r\n', 448, NULL, NULL),
(1123, 'Euzen Marie', NULL, 'redactor', 'Computer System Validation Specialist', 'I confirm that the execution of the plan will produce a system compliant with applicable procedures and regulations.', 449, NULL, NULL),
(1124, 'Noyon Laurent', NULL, 'review', 'Technical Unit', 'I confirm that the validation plan includes all activities and deliverables suitable for managing quality on this project.  \r\nI will execute this plan according to my responsibility, delivering a system fit for technical processes.\r\n', 449, NULL, NULL),
(1125, 'Perraudin Thomas', NULL, 'approvor', 'Business Responsible', 'I confirm that the validation plan includes all activities and deliverables suitable for managing quality on this project. \r\nI confirm that the execution of the plan will produce a system compliant with applicable procedures and regulations.  \r\n', 449, NULL, NULL),
(1126, 'Pucheu Marion ', NULL, 'review', 'Process Owner', 'I confirm that the validation plan includes all activities and deliverables suitable for managing quality on this project. \r\nI will execute this plan according to my responsibility, delivering a system fit for supporting business processes.\r\n', 449, NULL, NULL);

-- --------------------------------------------------------

--
-- Structure de la table `csv_software_test`
--

CREATE TABLE IF NOT EXISTS `csv_software_test` (
  `id` int(11) NOT NULL AUTO_INCREMENT,
  `code` varchar(255) NOT NULL,
  `id_project` int(11) NOT NULL,
  `functionnality` varchar(255) DEFAULT NULL,
  `type` varchar(255) NOT NULL,
  `objective` text NOT NULL,
  `prerequisite` varchar(255) DEFAULT NULL,
  `system_version` varchar(255) NOT NULL,
  `id_testor` int(255) DEFAULT NULL,
  `id_approvor` int(255) DEFAULT NULL,
  `id_follow` varchar(255) DEFAULT NULL,
  `VP_Version` int(255) NOT NULL,
  `test_version` int(255) NOT NULL,
  `signature` date DEFAULT NULL,
  `reason` text,
  PRIMARY KEY (`id`)
) ENGINE=MyISAM AUTO_INCREMENT=682 DEFAULT CHARSET=utf8;

-- --------------------------------------------------------

--
-- Structure de la table `csv_software_test_roll`
--

CREATE TABLE IF NOT EXISTS `csv_software_test_roll` (
  `id` int(11) NOT NULL AUTO_INCREMENT,
  `step` int(255) NOT NULL,
  `instructions` text NOT NULL,
  `evidence` tinyint(1) DEFAULT NULL,
  `file_evidence` varchar(255) DEFAULT NULL,
  `result` text NOT NULL,
  `state` varchar(255) DEFAULT NULL,
  `comment` text,
  `id_incident` varchar(255) DEFAULT NULL,
  `date_validation` date DEFAULT NULL,
  PRIMARY KEY (`id`)
) ENGINE=MyISAM AUTO_INCREMENT=330 DEFAULT CHARSET=utf8;

-- --------------------------------------------------------

--
-- Structure de la table `csv_software_urs`
--

CREATE TABLE IF NOT EXISTS `csv_software_urs` (
  `id` int(11) NOT NULL AUTO_INCREMENT,
  `code` varchar(255) NOT NULL,
  `risk_rank` varchar(5) NOT NULL,
  `detectability` varchar(5) NOT NULL,
  `risk_class` varchar(5) NOT NULL,
  `description` text NOT NULL,
  `id_category` int(11) NOT NULL,
  PRIMARY KEY (`id`)
) ENGINE=MyISAM AUTO_INCREMENT=485 DEFAULT CHARSET=utf8;
COMMIT;

