March 27, 2017 - Computer System Validation - Responsibilities: Requires thorough understanding of System Development Life Cycles for FDA regulated applications Must be experienced in developing Computer System Validation deliverables for FDA-regulated applications: Validation Plans, Requirement Specifications, various levels of software testing scripts ( IQ, OQ, PQ ), Traceability Matrix , and Validation Reports . Requires thorough knowledge of US CFR 21 Part 11 regulations.
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