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Computer Systems Validation in Clinical Research – A Practical Guide Edition 2

£20.00

The purpose of the 1st Edition of the Guideline was to suggest approaches by which validation might be achieved. The 2nd Edition updates these approaches in light of changes to the technology and regulatory landscape and provides additional guidance on the tools necessary to achieve validation, such as risk management and requirements analysis.  This Guideline is structured as an aid to both the novice and the experienced practitioner. It describes how to incorporate validation within the culture of an organisation via a high-level strategy, SOPs and clearly identified accountability.

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Validation encompasses the entire system development life-cycle from initiation through development, testing and production use, to decommissioning. The purpose of validation is to demonstrate that a system is developed, used, maintained, evolved and eventually decommissioned, in a controlled, documented manner that is consistent with it’s intended business use. A broad, holistic, view of computerised systems is taken to cover software, hardware, processes and people. Validation of clinical research computer systems is required by ICH regulatory guidelines on Good Clinical Practice and Statistical Principles for Clinical Trials as well as national regulations such as Title 21 of the US Code of Federal Regulations. However, the over­riding rationale for validation is that it makes good business sense by ensuring quality, timeliness and efficiency, and by effectively addressing business risks.  The purpose of the 1st Edition of the Guideline was to suggest approaches by which validation might be achieved. The 2nd Edition updates these approaches in light of changes to the technology and regulatory landscape and provides additional guidance on the tools necessary to achieve validation, such as risk management and requirements analysis.  This Guideline is structured as an aid to both the novice and the experienced practitioner. It describes how to incorporate validation within the culture of an organisation via a high-level strategy, SOPs and clearly identified accountability. While corporate management has ultimate responsibility for systems validation, specific responsibility for the implementation rests with user management. The generalities of reaching and maintaining the validated state, and the appropriate tools to use, are covered for any system from any source, from a one-off analysis program to a large multi-functional, multi-site installation, and from inception to decommissioning.  Aspects of different types of clinical research computerised systems which require special attention during validation arc highlighted. Such systems include administration, randomisation, drug supplies, web-based data capture and transfer, databases and associated review tools, statistical analysis, document management, publishing and regulatory submission, and pharmacovigilance.  Throughout the Guideline, emphasis is placed on the importance of good processes and procedures, training, adequate documentation and approval signatures to provide evidence that a system has been, and remains, properly validated. The Guideline is intended to provide guidance to all those with an interest in the validation of computerised systems in clinical research. The intended audience will range from the individual user of a small stand-alone system or one-off program, through groups with multi-level access, to senior managers who need guidance on the requirements for a corporate validation strategy and the validation requirements for their systems.