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.
Learn how to evaluate the applicability of 21 CFR Part 11 requirements for electronic systems following this 21 CFR Part 11 applicability assessment.
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...
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.
See release notes for SimplerQMS patch 3.0.3.
Check out our essential guide to 21 CFR Part 11 compliant electronic records. Learn what electronic records are, their requirements, and compliant system features.
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...
Learn all about an eQMS: its purpose, how it works, and key features, and discover the best eQMS software solutions for Life Sciences in 2023.
Download our 21 CFR Part 11 compliance checklist to verify if your electronic records and signatures are compliant. Get your free copy today!