Clinical trial agreements, regulatory submissions, GxP compliance documents, and batch record sign-offs — signed with 21 CFR Part 11 compliant e-signatures and tamper-proof audit trails.
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Pharmaceutical companies operating under FDA oversight must use 21 CFR Part 11 compliant electronic signatures for records. Zignature's audit trail architecture meets Part 11 requirements for identification code, timestamp, and meaning attribution.
FDA 21 CFR Part 11 compliant signatures for pharmaceutical records and submissions.
Clinical trial agreements, investigator site agreements, IRB submission documents, regulatory filing cover sheets, and FDA correspondence — all managed with compliant e-signatures.
CTA, ISAs, IRB documents, and FDA filing documents with compliant e-signatures.
GMP, GCP, and GLP documents require controlled signature workflows, version control, and long-term archival. Zignature's document management provides the structure required for GxP compliance programs.
GxP document lifecycle management with controlled signing and long-term archival.
From simple agreements to complex multi-party workflows.
No training required. Send your first document today.
IT enables Part 11 compliance mode — unique user auth, audit, and meaning fields.
CTA, ISA, batch record, SOP, and regulatory document templates configured.
Regulatory and clinical documents flow through configured approval chains.
All signed documents retained with Part 11 compliant audit trails.
Start your free trial — no credit card required.
Everything you need to know.
Zignature's audit trail and authentication architecture meets the key 21 CFR Part 11 requirements: unique user authentication, timestamped signature events, meaning attribution per signature, and tamper-evident audit trails. Formal Part 11 validation should be conducted by your quality team.
Yes. Sponsor-investigator clinical trial agreements, site management agreements, and clinical supply agreements are all suitable for Zignature e-signature. The audit trail provides the execution evidence required for regulatory inspection.
Yes. Manufacturing batch record review and approval signatures can be captured via Zignature with meaning attribution (reviewed, approved) and 21 CFR Part 11 compliant audit trails.
Zignature supports configurable retention policies. For pharmaceutical use, set 25-year retention on GxP documents — aligning with FDA data integrity guidance for electronic records.
Yes. Zignature's audit trail and electronic records are designed to withstand regulatory inspection. Export the audit trail report and signed document as your inspection-ready electronic record package.
Yes. Zignature offers HIPAA Business Associate Agreements on enterprise plans, covering pharmaceutical workflows that involve protected health information.