Posts tagged with "Electronic Records"

3 posts found

ComplianceFDAElectronic RecordsAudit Trails21 CFR Part 11

The Importance of Time-Stamps in 21 CFR Part 11 Audit Trails

Discover the role of time-stamped audit trails in 21 CFR Part 11, essential for ensuring compliance and data integrity in electronic records.

November 6, 2024

5 min read

ComplianceFDAElectronic RecordsPredicate Rules21 CFR Part 11

21 CFR Part 11 vs. Predicate Rules: Understanding Their Relationship

Explore the relationship between 21 CFR Part 11 and FDA predicate rules, focusing on compliance requirements for electronic records in regulated industries.

November 2, 2024

5 min read

ComplianceFDAElectronic RecordsElectronic SignaturesAnnex 11

21 CFR Part 11 Explained: A Complete Guide to FDA Electronic Records Compliance

Learn everything you need to know about 21 CFR Part 11 compliance, including electronic signatures, electronic records, and implementation requirements for FDA-regulated industries.

October 24, 2024

4 min read

Posts tagged with "Electronic Records"

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The Importance of Time-Stamps in 21 CFR Part 11 Audit Trails

21 CFR Part 11 vs. Predicate Rules: Understanding Their Relationship

21 CFR Part 11 Explained: A Complete Guide to FDA Electronic Records Compliance