Comply with Title 21 CFR Part 11 Digital Signature Requirements
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.
GlobalSign’s PDF signing certificates (which are part of Adobe’s Approved Trust List) create digitally signed documents that are compliant with FDA requirements, including how the signature appears in the document and how the signature and document are linked. For more details, please see our CFR 21 Part 11 Audit Support document, which details how our solution maps to each component of the regulation.
Features & Benefits
Certificate stored on USB token to protect signing credential
Compatible with Adobe Acrobat, LiveCycle, other signing apps
Third party timestamp and long term signature validity included
Add customizable approval signatures, such as an image of your physical signature or an engineering seal
Certify documents to prove authorship, finalize contents, and secure against future tampering.