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Erp

Resources on ERP systems — custom enterprise resource planning for manufacturing, procurement, inventory, and operations workflows.

12 posts

Enterprise Software

FDA 21 CFR Part 11 Software Requirements: What Your Development Team Needs to Know

21 CFR Part 11 defines the FDA's requirements for electronic records and electronic signatures in regulated industries. Software that manages manufacturing records, quality data, or batch documentation must meet specific technical requirements for audit trails, access controls, and signature validation — or the records it produces are not legally valid.

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