What is CFR Part 11 compliance?
WHAT IS 21 CFR PART 11? 21 CFR Part 11 is the FDA’s regulations for electronic documentation and electronic signatures. It outlines the administration of electronic records in a medical device company’s quality management system.
What is the main difference between Annex 11 and 21 CFR Part 11?
While the FDA 21 CFR covers US-based pharmaceutical companies, Annex 11 is a Good Manufacturing Practice (GMP) guideline in the European Union. 21 CFR part 11 is a regulation of the FDA that applies to drug manufacturers, biotech companies and other regulated industries.
What is the importance of the validation of the system in 21 CFR Part 11?
11.10(a) Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.
What is meant by 21 CFR?
21 CFR Rules are a set of rules which govern or regulate the management and usage of electronic records in pharmaceuticals and medical devices. 21 CFR Rules set out guidelines on the usages and management of electronic records as well as electronic signatures.
What is a Part 11 compliant signature?
The FDA regulation Title 21 CFR Part 11 sets the criteria under which the FDA considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.
Is SharePoint 21 CFR Part 11 compliant?
Why You Should Use SharePoint For Compliance Issues Of FDA Regulated Industries. Summary: SharePoint provides the essential tools required by CFR 21, Part 11 such as audits, system validations, audit trails, electronic signatures and documentation.
Is Annex 11 a regulation?
It’s important to note however that Annex 11 is not a regulation, like the FDA 21 CFR Part 11 rule is. Annex 11 is a guideline and is key to compliance with GMP principles in EU directives (regulations) covering human and veterinary medicinal products.
Does EU Annex 11 apply to medical devices?
Strictly speaking, Annex 11 applies only to medicinal products and not to medical devices. However, forward-thinking device companies may want to align their activities with the guidance.