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What is FDA 21 CFR Part 11? (32 Questions and Answers)

Jul 12, 2023 | 21 CFR Part 11

Explore the top FAQs about 21 CFR Part 11. We provide answers to questions on 21 CFR Part 11 requirements for electronic records and signatures.

21 CFR Part 11 Applicability Assessment

Jul 11, 2023 | 21 CFR Part 11

Learn how to evaluate the applicability of 21 CFR Part 11 requirements for electronic systems following this 21 CFR Part 11 applicability assessment.

Grouping Objects by Object Type

Jul 6, 2023 | Troubleshoot

If you have hundreds of items on your Recent or Assigned tab and would like to quickly navigate through the items, you can group objects by object type. By default, this should be enabled, but there...

21 CFR Part 11 and Training Records (What You Should Know)

Jun 23, 2023 | 21 CFR Part 11

Learn about 21 CFR Part 11 and its impact on training records. Explore the requirements, best practices, and role of eQMS in training record management.

SimplerQMS 3.0.3 Release Notes (Patch)

Jun 23, 2023 | Release Notes

See release notes for SimplerQMS patch 3.0.3.

21 CFR Part 11 Compliant Electronic Records (Guide)

Jun 20, 2023 | 21 CFR Part 11

Check out our essential guide to 21 CFR Part 11 compliant electronic records. Learn what electronic records are, their requirements, and compliant system features.

External Electronic Signature Blocks PDF Release Inside SimplerQMS

Jun 9, 2023 | Troubleshoot

The system will encounter PDF processing issues when uploading documents that have external electronic / digital signatures on them (e.g. Adobe Sign). This is regardless of the Class it is filed...