Computer System Validation job – Katalyst HealthCares & Life Sciences – TX

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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