Built for GxP Compliance

Every feature in GxPSign is designed with 21 CFR Part 11 and EU Annex 11 requirements in mind. No add-ons, no enterprise tiers - just compliant signatures from day one.

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21 CFR Part 11 Ready

Full compliance with FDA electronic records and signatures requirements

Self-Qualify in Weeks

Pre-built IQ/OQ/PQ packages included with every subscription

Predictable Pricing

Unlimited signatures, no per-envelope fees, all features included

Core Compliance

21 CFR Part 11 Compliance

GxPSign is designed from the ground up to meet FDA 21 CFR Part 11 requirements for electronic records and electronic signatures. Every aspect of the platform supports regulatory compliance.

  • Unique User Identification

    Each user has a unique account with email-based authentication

  • Access Controls

    Role-based permissions limit system access to authorized individuals

  • Record Integrity

    Cryptographic signatures ensure documents cannot be altered after signing

  • System Validation

    Included qualification packages support your validation requirements

Compliance Requirements Met

11.10(a) System Validation Included
11.10(d) Audit Trails Included
11.10(e) Record Integrity Included
11.100 Unique IDs Included
11.200 Signature Components Included

Audit Trail Entry

2024-01-15 14:32:18 UTC
Document Signed
User: [email protected]
IP: 192.168.1.xxx
Meaning: Approval
2024-01-15 14:32:15 UTC
Re-authentication Successful
User: [email protected]
Method: Password
2024-01-15 14:30:00 UTC
Document Viewed
User: [email protected]
Traceability

Complete Audit Trails

Every action in GxPSign is logged with a timestamp, user identity, and relevant details. Audit trails are immutable and available for export at any time.

  • Timestamped Actions

    UTC timestamps on every event for consistent global tracking

  • User Attribution

    Every action linked to specific user accounts

  • Immutable Records

    Audit logs cannot be modified or deleted

  • Export Capabilities

    Download audit trails for regulatory submissions

Signature Integrity

Signature Manifestation

Per 21 CFR Part 11.50, every signature includes the printed name, date/time, and meaning of the signature. This information is visually displayed on the signed document and cryptographically bound.

  • Printed Name

    Full name of the signer clearly displayed

  • Date and Time

    Precise timestamp when signature was executed

  • Signature Meaning

    Purpose of signature (approval, review, authorship, etc.)

  • Cryptographic Binding

    All elements permanently linked to the document

Document: SOP-001-Rev3.pdf
Digitally Signed
Signed by: Dr. Jane Wilson
Date/Time: 2024-01-15 14:32:18 UTC
Meaning: Approved
Reason: I have reviewed and approve this document

Confirm Your Identity

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Security

Re-authentication at Signing

Per 21 CFR Part 11.200, GxPSign requires users to re-authenticate before each signing event. This ensures the person signing is truly the account holder.

  • Password Verification

    Users must re-enter their password before signing

  • Session Timeouts

    Configurable session timeouts for additional security

  • Failed Attempt Logging

    All authentication attempts are logged in the audit trail

Ready to See GxPSign in Action?

Schedule a demo to see how GxPSign can simplify your GxP compliance and help you qualify faster.

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