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What is 21 CFR 11 – What Does It Address?

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What is 21 CFR 11 – What Does It Address?

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Part 11 has five central components. These are: • Validation • Glossary of Terms • Time Stamps • Maintenance of Electronic Records • Electronic Copies of Electronic Records In summary, the Rule requires certain functional requirements associated with processes that: collect, maintain, transmit, authenticate, and secure, regulatory data. These elements form a framework of system and application requirements, that may be challenging for system and software designers.

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