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Computer System 2020 - Best Practices To Help You Pass An FDA Computer System Validation Audit Training



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FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules.
FDA requires that all computer systems that handle data regulated by the Agency to be validated in accordance with their guidance on computerized systems. In 1997, 21 CFR Part 11 was issued to address electronic records and signatures,
Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology
“GxP” – Good Manufacturing, Laboratory and Clinical Practices
Carolyn Troiano is an independent consultant with more than two decades of experience working in pharmaceutical and biotechnology companies

Last modified: 2020-11-30 21:58:03