Life Sciences
21 CFR Part 11

Life Sciences Accelerated.

Drive efficiency without compromising compliance. Zignature delivers 21 CFR Part 11 compliant e-signatures for clinical trials, research agreements, and regulatory submissions.

21 CFR Part 11 Compliance — FDA-ready electronic signatures with full validation
Clinical Trial Consent — eConsent workflows for patient-facing clinical studies
GxP Document Control — validated document workflows for GMP, GLP, and GCP
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Clinical Consent
Phase III Trial
Active
This Month
2,400 Signed
+45% enrollment rate
100%
Compliant

Trial Activity

Live
eConsent: Patient #4521 Just now
Phase III enrollment signed
Amendment: Protocol v2.1 Review
Updated consent language
Withdrawal: Patient #4518 Processing
Voluntary withdrawal form
Research Agreements
Partnerships
Active
This Month
189 Active
+34% faster execution
3.2hr
Avg Turnaround

Agreement Pipeline

Active
CDA: BioGen Partners Just now
Confidential disclosure agreement
MTA: University Lab Review
Material transfer agreement
CRO MSA: TrialCo Pending
Contract research org
Clinical Trials

eConsent for Clinical Trials

Digital informed consent that meets FDA and ICH GCP requirements. Patients review and sign consent forms on any device with 21 CFR Part 11 compliant electronic signatures.

21 CFR Part 11 validated FDA-ready electronic signatures with full audit trails
Patient-friendly mobile consent participants sign from their phone or tablet
Version-controlled amendments track consent amendments with re-consent workflows
Regulatory Submissions
Regulatory Affairs
Active
This Month
56 Filed
+28% faster filing
Zero
Rejections

Regulatory Queue

This Quarter
IND Amendment: Drug X Just now
Safety update submission
510(k): Device Y Review
Pre-market notification
Annual Report: Drug Z This Month
Annual IND report
Quality

GxP Document Control

SOPs, batch records, deviation reports, and CAPAs — all with validated electronic signatures. Meet GMP, GLP, and GCP requirements with 21 CFR Part 11 compliant workflows.

Validated workflows IQ/OQ/PQ validated document signing workflows
Role-based signatures enforce signing order and approval hierarchies
Audit trail reports 21 CFR Part 11 compliant audit trail exports
Quality Documents
QA/QC
Active
This Month
4,200 Managed
+100% digital
ISO
Certified

Quality Pipeline

Today
SOP Approval: Batch Record Just now
Manufacturing SOP v3.0
Deviation Report: Lot 456 Review
Quality deviation investigation
CAPA: Action Item #89 Pending
Corrective action closure
Regulatory

Streamline Regulatory Submissions

IND amendments, 510(k) submissions, and annual reports — all with compliant signatures and document control. Reduce submission cycle time with automated routing and review workflows.

Submission-ready documents digitally signed documents accepted by FDA
Multi-reviewer workflows route through medical, regulatory, and QA review
Document lifecycle tracking track document status from draft through approval
Built for Life Sciences
PREVIEW

The Platform That
Researchers Trust

From biotech startups to global pharma, Zignature powers life sciences document workflows with regulatory-grade compliance.

100%
Compliant
5x
Faster
Zero
FDA Findings

eConsent for Clinical Trials

Digital informed consent that meets FDA and ICH GCP requirements. Patients review and sign consent forms on any device with 21 CFR Part 11 compliant e...

GxP Document Control

SOPs, batch records, deviation reports, and CAPAs — all with validated electronic signatures. Meet GMP, GLP, and GCP requirements with 21 CFR Part 11 ...

Streamline Regulatory Submissions

IND amendments, 510(k) submissions, and annual reports — all with compliant signatures and document control. Reduce submission cycle time with automat...

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21 CFR Part 11, GxP & ICH compliant
Life Sciences Hub
2,400
Consents Signed
100%
FDA Compliant
21 CFR Part 11 validated
eConsent for clinical trials
GxP document control
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Your Research Workflows?

Clinical consent, research agreements, regulatory submissions — all 21 CFR Part 11 compliant. Get started free today.

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