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FAQ · Compliance

How does ValidationMaster® support regulatory compliance?

Answer

ValidationMaster® provides structured validation workflows, end-to-end traceability, complete audit trails, role-based access, and electronic signatures. The platform is designed to support 21 CFR Part 11, EU Annex 11, GAMP® 5 Second Edition, FDA Computer Software Assurance (CSA), and ALCOA+ data integrity principles.

ValidationMaster eQMS™ is designed to support organizations operating under ISO 9001 Quality Management Systems and FDA Quality System Regulation (21 CFR Part 820).

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