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Welcome to GxPSign Help

Aligned with the stricter EU Annex 11 (2025 draft revision)

GxPSign is built to the tightened e-signature requirements in the EU GMP Annex 11 draft revision — including fresh per-signature re-authentication (§ 13.3, no session re-use), passkey / biometric authentication (§ 11.3), MFA on remote critical systems (§ 11.6), and a signing-event audit trail (§ 12.2) with the authenticator, device model (AAGUID), userVerified flag, and clone-detection sign counter recorded as queryable columns.

Existing 21 CFR Part 11 controls are preserved in parallel. See GxP Compliance → Regulatory Mapping for the per-clause breakdown, and Passkeys for the signer experience.

  • User Guide

    Learn how to sign documents, manage signature requests, and use GxPSign effectively.

    Get Started

  • Admin Guide

    Complete guide for organization administrators managing users, documents, and compliance settings.

    Admin Setup

Quick Start

New to GxPSign? Here's how to get started:

  1. Sign in to your organization's GxPSign instance
  2. Complete your profile with your signature
  3. Start signing documents sent to you

What is GxPSign?

GxPSign is a GxP-standard compliant electronic signature platform for organizations that need professional, auditable digital signatures. All organizations benefit from the same full-featured platform — GxP compliance features are available to any organization.

Pricing is seat-based: each SignatureManager seat ($950/seat) allows one user to create and send signature requests. Signed PDFs are clean and unbranded. Demo SignatureManager seats (free) let you try the workflow but add a DEMO watermark to signed PDFs.

Key Features

Feature Description
Compliant Signatures FDA 21 CFR Part 11 and EU GMP Annex 11 (draft revision) — fresh re-auth, passkey / biometric, MFA
Document Management Upload, organize, and track PDF documents
Digital Certificates Cryptographic PDF signing with timestamps
Audit Trails Comprehensive logging for compliance

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