{"id":702,"date":"2020-05-13T18:12:16","date_gmt":"2020-05-13T18:12:16","guid":{"rendered":"https:\/\/www.pharmity.com\/?p=702"},"modified":"2021-01-08T20:36:17","modified_gmt":"2021-01-08T20:36:17","slug":"validation-and-qualification-of-eclinical-systems-1","status":"publish","type":"post","link":"https:\/\/www.pharmity.com\/staging\/?p=702","title":{"rendered":"Validation and Qualification of eClinical Systems (1)"},"content":{"rendered":"\n\n<h4 align=\"justify\"><span style=\"color: #009999;\">Based on recent inspection findings, the GCP Inspectors Working Group \u00a0(IWG) and the Committee for Medicinal Products For Human Use (CHMP) recognize the need to emphasize requirements for sponsors\/vendors providing computerised systems or services as well as for the qualification and validation of computerised systems used to manage clinical trial data.<\/span><\/h4>\n<p><!--more--><\/p>\n<h3 style=\"text-align: justify;\" align=\"justify\"><span style=\"color: #009999;\"><strong>INTRODUCTION<\/strong><\/span><\/h3>\n<p style=\"text-align: justify;\"><span style=\"color: #333333;\">Acceptance of data from clinical trials for decision-making purposes depends on the Regulatory Authorities\u2019 ability to verify the quality and integrity of the data.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"color: #333333;\">As explained in this article, data integrity has become a major priority during regulatory inspections.\u00a0 \u00a0Deficiencies on <strong>the computerised systems used to generate and handle clinical trials data<\/strong> (moving forward referred to as eClinical systems), compromises not only the data integrity but also the data reliability and robustness. GCP applies to all parties involved in the clinical trial conduct including computerised systems vendors.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"color: #333333;\">The software used must be in a validated state. If the use of the software involves configuration\/programming for a clinical trial, this must be validated to ensure it is functioning correctly. For example: eCRF (design of entry screen, edit checks, clinical database), IRT (design of randomization and allocation system for IMP for a clinical trial), ePRO (design of entry screens, edit checks, data transfer), statistical package (programming for analysing data).<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"color: #333333;\">A considerable number of software applications are provided by, or purchased from, vendors and are customized to different degrees. Observations are raised during GCP inspections regarding the level of validation\/qualification needed to be performed by a sponsor when using a system that has already been (or is supposed to have been) validated by the supplier.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"color: #333333;\">The EMA \u201c<em>Notice to sponsors on validation and qualification of computerised systems used in clinical trials<\/em>\u201d published on the 7<sup>th<\/sup> of April 2020 reinforces that:<\/span><\/p>\n<ul style=\"text-align: justify;\">\n<li><span style=\"color: #333333;\">Data integrity, reliability and robustness will depend on the design and the validation status of the computerised systems used.<\/span><\/li>\n<li><span style=\"color: #333333;\">Failure to document and therefore demonstrate the validated state of a computerised system is likely to pose a <strong>risk to data integrity, reliability and robustness<\/strong>, which depending on the criticality of the affected data, may result in <strong>data rejection<\/strong>.<\/span><\/li>\n<\/ul>\n<p style=\"text-align: justify;\"><span style=\"color: #333333;\">The EMA notice to sponsors, covers two main aspects: documentation of qualification activities and contractual arrangements with eClinical systems vendors which we will explain in different articles.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"color: #333333;\">This first article focuses on the documentation requirements with regards to the eClinical systems qualification and validation activities and the sponsor role.<\/span><\/p>\n<p>\u00a0<\/p>\n<h3 style=\"text-align: justify;\"><strong><span style=\"color: #009999;\">SOFTWARE VALIDATION AND THE SPONSOR ROLE<\/span><\/strong><\/h3>\n<p style=\"text-align: justify;\"><span style=\"color: #333333;\"><strong>The responsibility to ensure the validated state is with the sponsor<\/strong> who is also responsible for <strong>providing adequate documented evidence<\/strong> on the validation process.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"color: #333333;\">It is expected that software systems are validated to accepted standards. Principles of computer system validation should also be applied to study specific builds\/programs\/applications, particularly:<\/span><\/p>\n<ul style=\"text-align: justify;\">\n<li><span style=\"color: #333333;\">Specifications<\/span><\/li>\n<li><span style=\"color: #333333;\">Testing against specifications (with traceability)<\/span><\/li>\n<li><span style=\"color: #333333;\">Approval and release<\/span><\/li>\n<li><span style=\"color: #333333;\">Change Control<\/span><\/li>\n<\/ul>\n<p style=\"text-align: justify;\"><span style=\"color: #333333;\">ICH GCP E6(R2), sections 5.2.1 and 5.5.3.a, respectively specify that , \u201c<em>the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor<\/em>\u201d and \u201c<em>the sponsor should ensure and document that the electronic data processing system(s) conforms to the sponsors established requirements for completeness, accuracy, reliability, and consistent intended performance (i.e. validation)<\/em>.\u201d<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"color: #333333;\">ICH GCP E6(R2), section 1.65 defines validation of computerised systems as \u201c<em>a process of establishing and documenting that the specified requirements of a computerised system can be consistently fulfilled from design until decommissioning of the system or transition to a new system<\/em>.\u201d<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"color: #333333;\">The system in question may be a system validated by the supplier, but installed at the sponsor premises, or a system provided as software-as-a-service (SaaS or cloud solution). If the sponsor is changing\/adding functionalities to the system, different requirements would apply.<\/span><\/p>\n<p>\u00a0<\/p>\n<h4 style=\"text-align: justify;\"><span style=\"color: #009999;\"><strong>Software Risk Assessment<\/strong><\/span><\/h4>\n<p style=\"text-align: justify;\"><span style=\"color: #333333;\">The validation approach should be based on a <strong>risk assessment<\/strong> that takes into consideration the <strong>intended use<\/strong> of the system and the potential of the system to affect <strong>subjects safety<\/strong> and <strong>reliability of trial results<\/strong>. The risk assessment should be justified by the sponsor and documented.<\/span><\/p>\n<p>\u00a0<\/p>\n<h4 style=\"text-align: justify;\"><span style=\"color: #009999;\"><strong>Vendor\/developer assessment<\/strong><\/span><\/h4>\n<p style=\"text-align: justify;\"><span style=\"color: #333333;\">The sponsor requires a high level of confidence that computerized systems will meet their technical, commercial, and regulatory requirements.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"color: #333333;\">The computerized system supplier should build quality and integrity into a software product during development, as it cannot been added effectively (e.g. through testing and rework) later by the sponsor. Suppliers should therefore be assessed to determine the adequacy of their development and support processes, through an in-depth assessment or audit.<\/span><\/p>\n<blockquote>\n<p style=\"text-align: justify;\"><span style=\"color: #333333;\"><strong>The sponsor may rely on qualification documentation provided by the vendor if the qualification activities performed by the vendor have been assessed as adequate<\/strong><\/span><\/p>\n<\/blockquote>\n<p style=\"text-align: justify;\"><span style=\"color: #333333;\">The sponsor could use the knowledge, experience, and qualification documentation of the supplier, providing that the following conditions are met:<\/span><\/p>\n<ul style=\"text-align: justify;\">\n<li><span style=\"color: #333333;\">The sponsor has a thorough knowledge about the vendor\u2019s quality system and qualification activities, and a proper understanding of the validation documentation that will be provided.<\/span><\/li>\n<li><span style=\"color: #333333;\">The assessment\/audit has been performed by qualified staff, knowledgeable not only on CSV principles but also on clinical trials regulations, with sufficient time spent on the activities and with cooperation from the vendor.<\/span><\/li>\n<li><span style=\"color: #333333;\">The assessment\/audit has gone sufficiently deep into the activities and that a suitable number of examples for relevant activities have been looked at (and documented).<\/span><\/li>\n<li><span style=\"color: #333333;\">The assessment\/audit report determined the vendor\u2019s qualification documentation to be satisfactory or that deficiencies can be mitigated by the sponsor. For example: A sponsor performing part of the qualification.<\/span><\/li>\n<li><span style=\"color: #333333;\">Both the sponsor and the vendor establish full configuration management for qualification and production environments.<\/span><\/li>\n<li><span style=\"color: #333333;\">The sponsor performed an Installation Qualification (IQ)\/Performance Qualification (PQ) of a system that depends on trained users.<\/span><\/li>\n<li><span style=\"color: #333333;\">When required during a GCP inspection, the qualification documentation and any other relevant documentation on the electronic system used for generating\/handling relevant clinical trial data or to maintain control and oversight of clinical trial processes, is made available to the inspectors in a timely manner irrespective of whether it is provided by the sponsor, CRO or the vendor. It is the sponsor\u2019s responsibility to ensure that these documents are available for inspections.<\/span><\/li>\n<li><span style=\"color: #333333;\">The sponsor or the clinical research organization (CRO) performing these activities for the sponsor, has detailed knowledge about the qualification documentation and can navigate in it and explain the activities as if they had performed the activities themselves.<\/span><\/li>\n<\/ul>\n<p style=\"text-align: justify;\"><span style=\"color: #333333;\">In case the sponsor cannot rely on a vendor to provide documentation, the sponsor must requalify the system on the basis of their own and of the vendor\u2019s system requirement specifications.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"color: #333333;\">If the clinical trial is ongoing, this has to be done without delay. If the trial is completed, this should be undertaken prior to the submission of the MAA.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"color: #333333;\">A documented risk assessment needs to be conducted to assess the impact on the integrity of the data captured and held by the computer system that was not in a confirmed qualified\/validated state following the retrospective qualification\/validation activity.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"color: #333333;\">Depending on the outcome of the requalification, the sponsor may need to change to a new vendor\/system. The required migration of previously captured clinical trial data should also be validated.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"color: #333333;\">Findings that are the responsibility of the sponsor will mostly be raised during an inspection for the lack of documentation and inadequate vendor assessment prior to the clinical trial initiation.<\/span><\/p>\n<p>\u00a0<\/p>\n<h4 style=\"text-align: justify;\"><span style=\"color: #009999;\"><strong>Essential Documentation Retention<\/strong><\/span><\/h4>\n<p style=\"text-align: justify;\"><span style=\"color: #333333;\">Documentation regarding the validation of processes and qualification of systems is considered essential by GCP inspectors and it is normally requested during inspections. This is irrespective of whether the sponsor has contracted out activities related to electronic systems and whether the sponsor choses to consider as an audit the above-mentioned assessment of vendor processes and documentation. <\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"color: #333333;\">GCP inspectors do not consider the documentation\/report of these activities as an audit report that falls under ICH GCP E6(R2), section 5.19.3(d) Auditing Procedures <em>\u201cTo preserve the independence and value of the audit function, the regulatory authority(ies) should not routinely request the audit reports. Regulatory authority(ies) may seek access to an audit report on a case by case basis when evidence of serious GCP non-compliance exists, or in the course of legal proceedings\u201d.<\/em><\/span><\/p>\n<p>\u00a0<\/p>\n<p><img loading=\"lazy\" class=\"alignnone wp-image-710\" src=\"https:\/\/i0.wp.com\/www.pharmity.com\/staging\/wp-content\/uploads\/2020\/05\/Table-1.png?resize=600%2C351&#038;ssl=1\" alt=\"\" width=\"600\" height=\"351\" srcset=\"https:\/\/i0.wp.com\/www.pharmity.com\/staging\/wp-content\/uploads\/2020\/05\/Table-1.png?resize=300%2C176&amp;ssl=1 300w, https:\/\/i0.wp.com\/www.pharmity.com\/staging\/wp-content\/uploads\/2020\/05\/Table-1.png?resize=768%2C450&amp;ssl=1 768w, https:\/\/i0.wp.com\/www.pharmity.com\/staging\/wp-content\/uploads\/2020\/05\/Table-1.png?resize=249%2C146&amp;ssl=1 249w, https:\/\/i0.wp.com\/www.pharmity.com\/staging\/wp-content\/uploads\/2020\/05\/Table-1.png?resize=50%2C29&amp;ssl=1 50w, https:\/\/i0.wp.com\/www.pharmity.com\/staging\/wp-content\/uploads\/2020\/05\/Table-1.png?resize=128%2C75&amp;ssl=1 128w, https:\/\/i0.wp.com\/www.pharmity.com\/staging\/wp-content\/uploads\/2020\/05\/Table-1.png?w=934&amp;ssl=1 934w\" sizes=\"(max-width: 600px) 100vw, 600px\" data-recalc-dims=\"1\" \/><\/p>\n<p style=\"text-align: justify;\"><span style=\"color: #333333;\">Records pertaining to the validation of the software are essential documents and should be retained by the sponsor (or access to them at the computerised system vendor contractually) (see Table 1).<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"color: #333333;\">The records demonstrating that the trial specific configuration is in the validated state are essential documents and should be part of the Trial Master File (TMF) (see Table 1).<\/span><\/p>\n<p>\u00a0<\/p>\n<h3 style=\"text-align: justify;\" align=\"justify\"><span style=\"color: #009999;\"><strong>CONCLUSION<\/strong><\/span><\/h3>\n<p style=\"text-align: justify;\"><span style=\"color: #333333;\">Sponsors shall be able to provide the GCP inspectors with access to the requested documentation regarding the qualification and validation of computerised systems irrespective of who performed these activities. Failure to provide access to the documentation is likely to result in critical findings that will impact the acceptability of the clinical trial data.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"color: #333333;\">It is not acceptable to use computerised systems in clinical trials for which the validation status is not confirmed or for which appropriate documentation on system validation cannot be made available to GCP inspectors. It is clearly emphasized on the EMA notice to sponsors that this requirements is \u00a0irrespective of the number of sponsors making use of or having used the systems, the number of years such systems have been on the market etc., as serious GCP non-compliances and risks to data integrity, reliability and robustness could exist unnoticed if auditors and GCP inspectors are not allowed access.<\/span><\/p>\n<p>\u00a0<\/p>\n<p><strong>Remember that you can now access our\u00a0<span class=\"ac-designer-copy\">ICH GCP E6 (R2) for Investigators and Clinical Research staff online course below:<\/span><\/strong><br class=\"ac-designer-copy\" \/><br class=\"ac-designer-copy\" \/>\ud83d\udc49\u00a0<strong><a class=\"ac-designer-copy\" href=\"https:\/\/www.pharmity.com\/staging\/gcp-course\/\" target=\"_blank\" rel=\"noopener noreferrer\"><span class=\"ac-designer-copy\">JOIN NOW: ICH Good Clinical Practice (GCP) E6 (R2)<\/span><\/a><\/strong><\/p>\n<h3 style=\"text-align: justify;\" align=\"justify\"><strong><br \/><span style=\"color: #009999;\">REFERENCES<\/span><\/strong><\/h3>\n<ul style=\"list-style-type: circle;\">\n<li>\n<h6><span style=\"color: #333333;\"><span style=\"font-size: small;\">International Council for Harmonization (ICH): ICH Harmonized Guideline, Integrated Addendum to ICH E6(R1): <\/span><span style=\"font-size: small;\"><i>Guideline for Good Clinical Practice<\/i><\/span><span style=\"font-size: small;\"> E6(R2). Step 4, version 9 November 2016. <\/span><\/span><\/h6>\n<\/li>\n<li>\n<h6><span style=\"font-size: small; color: #333333;\">EMA. Notice to Sponsors on validation and qualification of computerised systms used in clinical trials. April 2020.<\/span><\/h6>\n<\/li>\n<li>\n<h6><span style=\"font-size: small; color: #333333;\">EMA Website. GCP Q&amp;A section (Q&amp;A #9)<\/span><\/h6>\n<\/li>\n<li>\n<h6><span style=\"color: #333333;\">MHRA. GCP Symposium. Computer System Validation, A.Fisher. February 2019, London (UK)<\/span><\/h6>\n<\/li>\n<li>\n<h6><span style=\"font-size: small; color: #333333;\">ISPE GAMP\u00ae Good Practice Guide: A Risk-Based Approach to Compliant Electronic Records and Signatures, 2005, International Society for Pharmaceutical Engineering (ISPE).<\/span><\/h6>\n<\/li>\n<\/ul>\n<p style=\"text-align: justify;\" align=\"justify\"><span style=\"color: #009999;\"><span style=\"font-size: medium;\">Author: Dr Leire Z\u00fa\u00f1iga, Director and Principal GCP Consultant<\/span><\/span><\/p>\n<p style=\"text-align: justify;\" align=\"justify\"><span style=\"color: #009999;\"><span style=\"font-size: medium;\"><b>PHARMITY<\/b><\/span><\/span><span style=\"color: #009999;\"><span style=\"font-size: medium;\">, 13th of May 2020<\/span><\/span><\/p>\n<p style=\"text-align: justify;\" align=\"justify\"><a href=\"http:\/\/www.pharmity.com\/staging\/\"><span style=\"font-size: medium;\">www.pharmity.com<\/span><\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Based on recent inspection findings, the GCP Inspectors Working Group \u00a0(IWG) and the Committee for Medicinal Products For Human Use (CHMP) recognize the need to emphasize requirements for sponsors\/vendors providing computerised systems or services as well as for the qualification and validation of computerised systems used to manage clinical trial<span class=\"excerpt-hellip\"> [\u2026]<\/span><\/p>\n","protected":false},"author":3,"featured_media":722,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_exactmetrics_skip_tracking":false,"spay_email":""},"categories":[24,17],"tags":[25],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v16.0.2 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Validation and Qualification of eClinical Systems (1) | Pharmity<\/title>\n<meta name=\"description\" content=\"Data Integrity - How To Implement An Effective Audit Trail | What makes a good audit trail that is effective and complies with regulations? 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