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How to Validate a Pharmaceutical ERP System: A Step-by-Step Guide for 21 CFR Part 11 Compliance
Slingshot Pharma’s guide outlines a step-by-step approach to validating pharmaceutical ERP systems for 21 CFR Part 11 compliance. It emphasizes developing a Validation Master Plan, defining user and functional requirements, and conducting rigorous testing. The article highlights the importance of ensuring data integrity, regulatory compliance, process efficiency, and audit readiness to avoid potential FDA sanctions.
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