FDA CFR 21 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."

Anthony McKinney, President and CEO, Euthymics Bioscience

Digital Signing Pricing & Product Options

Pricing depends on the volume of certificates that you need. Certificates are token-based and can be purchased online individually or in packs with assistance from an Account Manager. Volume discounts are available for certificate packs. Or if you are interested in a server-based solution, please contact a Sales Representative for more information.

  Desktop Solution (token-based)
Product Individual Certificates Certificate Packs
Certificate Storage USB Token USB Token
Lifecycle Management Each certificate managed individually All certificates managed from one account
Purchase Process Direct online Via Managed PKI portal
Identity on Certificate Named Individual (e.g., John Smith)
or
Named Department (e.g., Accounting)
Named Individual (e.g., John Smith)
or
Named Department (e.g., Accounting)
Signature Limit Per Year Unlimited Unlimited
Timestamping Services Included Included
Pricing
1 year Bulk discounts available
2 years Bulk discounts available
3 years Bulk discounts available
 

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