FDA

21 CFR 11 compliance

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secured by e-signatures

SEAMetal HD (version 5.1 and up) supports the technical requirements for the FDA's 21 CFR Part 11 regulatory codes.

These codes govern and outline the use of data security and integrity for critical data. The system puts into place not only regulatory requirements governing how e-signatures, audit trail, encryption and authentication - but also rules and regulations for training, procedural and operator/administrator accountability.

21 CFR 11 compliance

FDA 21 CFR Part 11 Compliance

SEAMetal HD (version 5.1 and up) supports the technical requirements for the FDA's 21 CFR Part 11 regulatory codes.

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