Are Adobe PDF signatures Part 11 compliant?
This handbook discusses how, with proper system implementation and appropriate procedural controls, electronic signatures generated through Adobe Sign can be legally binding and compliant with the requirements of 21 CFR Part 11 and EudraLex Annex 11.
What is CFR Part 11 compliance?
Part 11 compliant systems must have security features that limit user access and their privileges. Some examples of these security features include making sure users have unique usernames and passwords, being able to detect and prevent unauthorized system access and even locking compromised accounts. 2.
What computer systems must be compliant with 21 CFR Part 11?
What Computer Systems Must Be Compliant With 21 CFR Part 11? All computer systems which store quality critical data or are used to make decisions about quality must be compliant with 21 CFR Part 11. Furthermore, any system that is used for reporting data to the FDA must also be Part 11 Compliant.
What is a Part 11 compliant signature?
Part 11 describes the circumstances for when the FDA considers electronic signatures to be trustworthy, reliable, and equivalent to handwritten signatures executed on paper.
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.
Who does part 11 apply to?
BACKGROUND. In March of 1997, FDA issued final part 11 regulations that provide criteria for acceptance by FDA, under certain circumstances, of electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records and handwritten signatures executed on paper …
Are DocuSign signatures Part 11 compliant?
DocuSign offers modules to support your compliance with the electronic signature practices set forth in the U.S. Food and Drug Administration’s 21 CFR Part 11. Our core Part 11 module includes Part 11-specific eSignature functionality for authentication, reason for signature, and signature manifestation.