FDA Digital Certificates

GlobalSign provides compatible digital certificates for all your FDA needs. Whether you are using the standard FDA Electronic Submissions Gateway (ESG), WebTrader Hosted Solution (WTHS), AS2 account or need to secure your email communications to the FDA GlobalSign has you covered.

Digital Certificates for use with the FDA are used to encrypt documents in transmission and the FDA uses the Digital Certificate to verify the integrity of the document received from a specified source. The same digital certificate can be utilized to send secure encrypted email messages to the FDA and other external recipients.

GlobalSign has been providing digital certificates for the FDA for over 5 years since the original inception of the FDA ESG and is one of the worldwide leading Certificate Authorities. Choose GlobalSign for all your digital certificate needs.

Digital Certificates for use with:

  • FDA Electronic Submissions Gateway (ESG)
  • Applicability Statement (AS2) Server
  • Sending secure email to/from the FDA

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 whether you need a token- or server-based solution. Token-based solutions can be purchased online individually or in packs, while server-based solutions require assistance from an account manager. Volume discounts are available for bulk orders for both token-based or server-based solutions.

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

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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 (joe.smith@abc.com) Email address, individual identity & company identity (Joe Smith, ABC Company, joe.smith@abc.com)
Meets ESG Requirements
Meets Secure Email Requirements
Support: Help Desk Ticket Only Email, phone, help desk ticket & live chat
Pricing
Pricing 1 year:
Pricing 3 year:
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Need Help?

Contact GlobalSign for help and information

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