How Logilab SDMS Helps Laboratories Enable 21 CFR Part 11 Compliance - Part 3
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How Logilab SDMS Helps Laboratories Enable 21 CFR Part 11 Compliance - Part 3
Understanding 21 CFR Part 11 is only the first step. Laboratories must also demonstrate that their computerized systems practically implement technical and procedural controls for electronic records, electronic signatures, security, and traceability. This white paper focuses on how Logilab SDMS addresses specific Part 11 subparts and clauses by embedding compliance driven controls into everyday system operation.
Inside this white paper, you will learn:
- How electronic records are protected, retrieved, and audit trailed within Logilab SDMS
- How electronic signature manifestations and record linking are managed
- How identification codes, passwords, and security policies are implemented to meet Part 11 expectations
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