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This procedure defines the requirements for the validation of off-the-shelf and configured computer systems. It takes a life cycle approach that spans from the initial need for a system through requirements development, systems selection, system implementation and risk mitigation, validation testing, system use, and retirement. This life cycle, called RiskVal is described in detail in The Computer System Risk Management and Validation Life Cycle (Paton Press, 2006). It is a practical guide for the validation of high-, moderate- and low-risk systems to meet FDA's requirements and ISO 13485. 32 pages.
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This procedure provides detailed outlines of what needs to be included in the most important computer system validation deliverables, including requirements, validation plans, IQ, OQ and PQ protocols, protocol reports, and the validation final report. This procedure is of great value to those who are not familiar with these types of documents and those who want to verify that what they are including in their documents is what auditors look for. 20 pages
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Vendor qualification is required by the FDA and ISO 13485. The vendor qualification of most companies is centered on first article inspection of parts. This procedure answers the question: How do I qualify software and hardware vendors.
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Poorly developed software could have ten times as many defects as well engineered software. As with other products, quality has to be built in. If the software is of poor quality, validation testing is not going to make it function properly. This checklist is a form for conducting an on-site audit of a software vendor's quality system, and software development and support processes. It can be used to determine if the vendor has built the software you intend to purchase with the software development practices associated with quality software and recommended in the FDA guidance document on computer system validation. 44 pages
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