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."

Anthony McKinney, President and CEO of Euthymics Bioscience

Prices & Product Options Digital Signature

The price depends on the number of certificates you need. Certificates are based on tokens and can be purchased online individually or in packages with the help of an account manager. Volume discounts are available for packages of certificates. Or, if you are interested in a server-based solution, please contact a representative for more information.

  Desktop solution (token based)
Product Individual certificates Packages of certificates
Certificate storage USB token USB token
Life cycle management Each certificate is managed individually All certificates are managed from one account
Purchase process Directly online Via managed PKI portal
Identity on certificate Named person (eg John Smith) or said department (eg Accounting) Named person (eg John Smith) or said department (eg Accounting)
Signature limit per year Unlimited Unlimited
Time stamping services Including Including
1 year Bulk discounts available
2 years Bulk discounts available
3 years Bulk discounts available

Looking for FDA Electronic Submissions Gateway (ESG) certificates?

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