FDA Digital Certificates
Title 21 CFR Part 11
Comply with FDA digital signature regulations and create trusted documents
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
"By combining a physical token and a password to protect access, GlobalSign’s PDF Signing solution delivers both security and convenience to end users."
Who Needs FDA ESG Digital Certificates?
FDA ESG Compliant Digital Certificates from GlobalSign
Digital Certificates are required for submitting electronic documentation to the FDA Electronic Submissions Gateway. The digital certificate is used to encrypt documents for transmission as well as verify the identity of the company sending the document to the ESG.
The minimum requirement for a Digital Certificate for use with the FDA Electronic Submissions Gateway is a Personal Identification Certificate which GlobalSign brands as PersonalSign1 Certificate. GlobalSign also offers a high level security (PersonalSign2Pro) that binds to the individual's name, company name and email.
|PersonalSign 1||PersonalSign 2 Pro|
|Digital Certificate Binds to:||Email address only (email@example.com)||Email address, individual identity & company identity (Joe Smith, ABC Company, firstname.lastname@example.org)|
|Meets ESG Requirements|
|Meets Secure Email Requirements|
|Support:||Help Desk Ticket Only||Email, phone, help desk ticket & live chat|
|Pricing 1 year:||•||•|
|Pricing 3 year:||•||•|
|Buy Now||Buy Now|