Secure eSignatures that meet 21 CFR Part 11 requirements
Pass FDA audits with confidence and keep quality agreements, clinical trials, and change controls moving without delays. Included in your enterprise plan
at no extra cost.
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Make FDA compliance automatic across your organisation
Avoid warning letters, fines, product delays, and costly recalls. Every signature captures signer identity, timestamps, and signing reason, so documents meet 21 CFR Part 11 standards by default.
Keep secure records from start to finish
Take control of regulated workflows from SOP approvals to batch records. Restrict access by role, set multi-factor authentication, and lock documents once signed so you can trust every record is protected, complete, and authentic.
Stay audit-ready as you scale
Growth brings more documents, sites, and scrutiny. Get version-controlled records, full document histories, and certificates of completion that are ready for FDA inspection at every stage of your expansion.
Testimonials
National Clinical Homecare Association
“Out of twenty companies who responded, we chose eSign because they were the most responsive, understood the challenges involved and helped us to build a robust, persuasive business case behind the project. Given the scale of prescriptions going through, it was also important that a cost-effective solution could be delivered.”
Why life science orgs choose eSign for 21 CFR Part 11
Advanced eSignatures by default
Unlike other solutions, we only offer advanced eSignatures or higher, meeting GDPR and eIDAS requirements without extra cost or setup.
Government-approved supplier
We’re the only eSignature provider on the UK Government’s Public Service Network, meeting strict security standards for public sector organisations.
Secure authentication built in
Every document includes proof of signer identity, signing reason, and an audit trail, so signatures are defensible under FDA review.
Transparent pricing
No overages or hidden fees. We offer clear, scalable pricing that works for organisations of any size.
Secure API & Developer Hub
Our API and Developer Hub offer useful guides to help you build a bespoke integration tailored to your requirements.
UK data residency
All data is stored in secure, ISO 27001-certified facilities, ensuring GDPR compliance, data sovereignty, and peace of mind for sensitive information.
Turn existing workflows into FDA-compliant processes
Integrate eSign with your existing systems to keep regulated workflows connected without changing how you work.
See how eSign supports
21 CFR Part 11 compliance
Frequently Asked Questions
How does eSign ensure compliance with 21 CFR Pt.11?
eSign has a 21 CFR Pt. 11 validation module that supports compliance through our leading electronic signature platform.
Our validated Part 11 module includes specific eSignature features for authentication, reason for signature, and signature manifestation.
These tools ensure regulatory compliance while making the signing process faster, more cost-effective, and convenient for all parties involved.
For more information, get in touch with our Digital Transformation team.
Who is required to be compliant with 21 CFR Pt.11?
Any organisation that is regulated by the FDA or carries out activities that are related to FDA-regulated products is required to comply with 21 CFR part 11. These often include, but are not limited to, the below industries:
- Food and beverage manufacturers
- Cosmetic manufacturers
- Clinical laboratories
- Medical device manufacturers
- Pharmaceutical companies
- Contract research and manufacturing organisations
- Biotechnology companies
What are the 21 CFR Pt.11 requirements?
In order for the FDA to accept eSignatures in place of handwritten signatures, they must meet a specific set of criteria:
- The printed name of the signer
- A unique user ID
- The date and time of the signature
- Digital adopted signature
- The meaning of the signature (“signing reason”)
Other requirements also include:
- Each eSignature must be unique to only one individual and not reused by anyone else
- The identity of the signer must be verified before the electronic signature is applied
- There must be additional evidence from the eSignature provider that certifies that the signature is legally binding
- If the signature is not based on biometrics, it must use two distinct components for identification, such as an ID code and a password
- The eSignature platform used must have safeguards in place to prevent unauthorised access to documents and stop unpermitted use of identification codes and passwords
What happens if you don’t comply with CFR Pt.11?
If you’re required to comply with the regulation and you are not, you can face serious consequences such as
- Warning letters
- Initiation of disqualification proceedings
- Notices of inquiry
- Criminal fines
- FDA-regulated products seized
- Recalls
- Criminal prosecution
- Retention orders
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