E-Signatures Built for Health Regulatory Compliance
GxPSign meets the stringent e-signature requirements of the FDA and EMA — including meaning of signature, re-authentication, and immutable audit trails. Open to any organisation, built for those who cannot compromise.
Simple & Self-Service
No implementation project required. Sign up, create your organization, and start sending signature requests the same day.
Fast & Easy to Validate
Designed for GAMP5 validation from day one. Clear documentation, audit trails, and a predictable feature set make PQ straightforward. IQ/OQ/PQ Validation package included.
Straightforward Pricing
Transparent seat-based pricing for Signature Managers — unlimited Signers with no hidden fees. Know exactly what you pay before you commit.
Built to the Highest Regulatory Standard
GxPSign is designed for the e-signature requirements of the FDA (21 CFR Part 11) and EMA (EU Annex 11) — meaning of signature, re-authentication, and immutable audit trails are standard features, not optional add-ons.
Document Management
Upload PDF or Word documents for e-signing. Organize and manage files with version control and access tracking.
Digital Signature Workflow
Create signature requests, place fields on documents, and track signing progress in real-time.
FDA 21 CFR Part 11
Full compliance with the US FDA's regulation on electronic records and electronic signatures. Every signature is legally equivalent to a handwritten signature under US law.
EU Annex 11 / EMA
Meets EMA GxP requirements for computerised systems, including audit trails, data integrity, and electronic signature controls under EU Annex 11.
Meaning of Signature
Signers declare the intent of each signature (e.g. Reviewed, Approved, Authored) as required by 21 CFR Part 11.50 and EU Annex 11. Captured and embedded in the signed PDF.
Immutable Audit Trails
Every action — document upload, signature request, field placement, signing event — is permanently recorded with user identity, timestamp, and IP address. Tamper-evident and inspector-ready.
Re-Authentication
Identity is re-verified at the moment of signing, not just at login. Required by 21 CFR Part 11.200(b) for each discrete signature event in a signing session.
Cryptographic PDF Signing
Signatures are embedded cryptographically into the PDF using industry-standard PAdES. Documents are tamper-evident and verifiable by any PDF reader, meeting GAMP5 Category 4 requirements.
Email Notifications
Automated email notifications keep all parties informed throughout the signing process.
Trusted Timestamps
RFC 3161 trusted timestamps from TSA providers ensure document integrity and prevent backdating.
How GxPSign Works
A simple, secure process for getting documents signed
Upload Document
Upload your PDF or Word document to GxPSign
Add Signers & Meaning
Assign signers and set the meaning of each signature
Place Fields
Position signature and initials fields on the document
Send Request
Signers receive secure email links to sign
Get Signed PDF
Receive a cryptographically signed PDF with full audit trail
Ready to Get Started?
Create a free account and start sending compliant e-signature requests in minutes. No credit card required.
Create AccountSignatures That Stand Up to Regulatory Scrutiny
Built for the FDA and EMA. Available to everyone. Create your Organization account and test using free demo signature requests and experience what compliant e-signing looks like.