FDA-compliant electronic signatures and records for pharmaceutical, biotech, clinical research, and medical device organizations. Complete audit trail, unique user authentication, and tamper-evident records.
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FDA's 21 CFR Part 11 establishes specific technical requirements for electronic signatures in regulated industries: unique user ID and password, system access controls, secure audit trails, and tamper-evident documentation. Zignature satisfies each requirement through authentication controls, comprehensive logging, and cryptographic document sealing.
FDA's 21 CFR Part 11 establishes specific technical requirements for electronic signatures in regulated industries: uniq...
21 CFR Part 11 requires that electronic records be accurate, complete, consistent, legible, and retrievable throughout the records' retention period. Every Zignature-signed document is stored with its full audit trail in a format that is readable, printable, and producible on demand — satisfying FDA inspection and regulatory review requirements.
21 CFR Part 11 requires that electronic records be accurate, complete, consistent, legible, and retrievable throughout t...
Zignature operates as a closed electronic system — access controlled through unique user authentication and role-based permissions. System validation documentation, user training records, and access logs are available to support your 21 CFR Part 11 validation requirements for regulatory submissions.
Zignature operates as a closed electronic system — access controlled through unique user authentication and role-based p...
From simple agreements to complex multi-party workflows.
IRB-approved informed consent forms for human subjects research — 21 CFR Part 11 compliant signatures for FDA-regulated studies.
Pharmaceutical batch record sign-offs with unique user authentication — Part 11 compliant for current Good Manufacturing Practice compliance.
SOPs, deviation reports, CAPA documentation, and change control records — signed with 21 CFR Part 11 compliant electronic signatures.
Design History File documentation sign-offs for 21 CFR 820 compliance — electronic signatures with complete audit trail.
Electronic laboratory notebook (ELN) record authentication for regulated research — Part 11 compliant signature and date entries.
Vendor quality agreements and supplier audit acknowledgments — Part 11 compliant execution for pharmaceutical supply chain compliance.
No training required. Send your first document today.
Pick from pre-built compliant templates or upload your own document — our system applies the right compliance rules automatically.
Enable HIPAA BAA, GDPR DPA, identity verification, or QES as required for your regulatory environment.
Recipients get a secure link and are guided through the signing process with all required disclosures and consent flows.
Every transaction is sealed with a tamper-proof certificate of completion — ready for audits, regulators, and legal proceedings.
Join pharma, biotech, and medical device companies using Zignature. Free to start.
Everything you need to know.
21 CFR Part 11 is the FDA regulation (Title 21 Code of Federal Regulations Part 11) that establishes the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records and handwritten signatures. It applies to records required by FDA regulations and submitted to FDA.
21 CFR Part 11 applies to FDA-regulated industries including: pharmaceutical and biopharmaceutical companies, medical device manufacturers, clinical research organizations (CROs), contract manufacturing organizations (CMOs), food and dietary supplement manufacturers, cosmetic companies, and any organization submitting electronic records to FDA.
Key requirements include: (1) unique user authentication — each signer must be uniquely identified, (2) each electronic signature must be linked to its respective electronic record, (3) electronic signatures executed after August 20, 1997 must be accompanied by a statement that the signature is the legally binding equivalent of a handwritten signature, and (4) a complete audit trail must record all signature events.
Yes. Zignature satisfies the Part 11 requirements for informed consent signatures in FDA-regulated clinical trials: unique participant identification, secure audit trail, tamper-evident records, and long-term retrievability. For studies also requiring IRB review, your IRB must approve the electronic consent process prior to implementation.
Yes. Zignature provides SOC 2 Type II certification, which serves as third-party validation documentation supporting your system validation requirements. Enterprise plans include access to validation documentation packages including system description, test evidence, and data integrity specifications to support your regulatory submissions.
A closed system (§11.10) is an environment where access is controlled by persons responsible for the electronic records. A closed system requires specific controls including access limits, audit trails, and system validation. Zignature operates as a closed system — access is controlled through unique user authentication and organizational role assignments.
Retention periods depend on the specific FDA regulation the records satisfy. Clinical trial records may require retention for 2 years after marketing application, GMP records for 1-3 years after product release, and device records for 2 years after commercial distribution. Zignature stores all records indefinitely with configurable retention policies on enterprise plans.
Yes. Zignature's audit trail documents all document creation, modification, access, and signing events with user identity, date, time, and a description of the action. The audit trail is computer-generated, cannot be disabled by users, and is independent of the operator — satisfying 21 CFR Part 11 §11.10(e) audit trail requirements.
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