FDA CFR 21 Digitale certificaten
Title 21 CFR part 11
Comply with FDA digital signature regulations and create trusted documents
The FDA Regulation Title 21 CFR Part 11 establishes the criteria under which the FDA electronic records, electronic signatures and handwritten signatures performed on electronic records are credible, reliable, and generally equivalent to paper records and hand-paper signatures are considered.
GlobalSign PDF Signing Certificates (which are part of Adobe's Approved Trust List) create digitally signed documents that meet FDA requirements, including how the signature appears in the document and how the signature and document are associated. For more details, please refer to our CFR 21 Part 11 Audit Support document, which describes in detail how our solution relates to each part of the regulation.
Features & Benefits
- Certificate stored on USB token to secure the signature reference
- Compatible with Adobe Acrobat, LiveCycle and other signing apps
- Includes third-party time stamp and long-term signature validity
- Add customizable signatures for approval, such as an image of your physical signature or a technical seal
- Certify documents to prove authorship, finalize content, and protect against future manipulation
"By combining a physical token and password to protect access, GlobalSign's PDF signing solution provides both security and convenience to end users."