Electronic Signatures for Regulated Industries
The secure e-signature platform built for clinical trials, pharmaceuticals, and life sciences. Complete FDA, EU CTR 536/2014, and GDPR compliance with 25-year document retention.
Clinical Protocol v2.1
Informed Consent Form
Site Agreement
Complete audit trail with hash-chain verification
Compliant with global regulatory standards
Get Documents Signed in Three Steps
Streamlined workflow designed for regulatory compliance without the complexity
Upload Document
Upload your PDF document and add signature fields, initials, dates, and custom form fields.
Add Signers
Add recipients with sequential or parallel routing. Set signing order and deadline reminders.
Track & Complete
Monitor signing progress in real-time. Download signed documents with complete audit trails.
Built for Compliance & Security
Every feature designed to meet the strictest regulatory requirements
FDA 21 CFR Part 11
Complete compliance with validation documentation, IQ/OQ protocols, and configurable controls.
ALCOA+ Audit Trails
Immutable hash-chain audit trails capturing who, what, when, where, and why for every action.
25-Year Retention
EU CTR 536/2014 compliant document retention with guaranteed accessibility.
Two-Factor Authentication
Enterprise-grade security with TOTP-based 2FA and backup codes.
Flexible Workflows
Sequential or parallel signing with automated reminders and deadline management.
Regulatory Exports
One-click compliance packages for FDA, MHRA, or EMA inspections.
Ready for FDA, EU & UK Inspections
The first e-signature platform with built-in compliance for EU Clinical Trial Regulation 536/2014, UK MHRA 2026 requirements, and FDA 21 CFR Part 11.
25-Year Retention
EU CTR Article 58 compliant storage
Regulatory Exports
One-click compliance packages
GDPR Records
Article 30 processing activities
Archive Management
Named individual responsibility
Trusted by Regulated Industries
Purpose-built for organizations requiring validated, compliant electronic signature systems
Clinical Research
Informed consent, protocols, site agreements
Pharmaceutical QA
Batch records, SOPs, deviation reports
Medical Devices
Design history files, validation protocols
Laboratory Systems
Test results, method validation, logs
Ready to Go Paperless?
Join clinical sites and pharmaceutical companies using Certivo for FDA-compliant electronic signatures. Start your free trial today.
No credit card required • 14-day free trial • Full validation documentation included
Frequently Asked Questions
What is FDA 21 CFR Part 11 compliance?
FDA 21 CFR Part 11 establishes the criteria for electronic records and electronic signatures to be considered trustworthy, reliable, and equivalent to paper records. Certivo ensures complete compliance with validation documentation, ALCOA+ audit trails, system access controls, unique user identification, and configurable record retention up to 25 years.
What is EU CTR 536/2014 and why does it require 25-year retention?
EU Clinical Trial Regulation 536/2014 is the European regulatory framework for clinical trials. Article 58 requires sponsors to retain the clinical trial master file for at least 25 years after the trial ends. This ensures long-term safety monitoring and allows regulatory authorities to access complete trial documentation.
What is ALCOA+ and why is it important?
ALCOA+ is the data integrity framework required by FDA and EU GMP Annex 11. It stands for Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available. Certivo audit trails meet all ALCOA+ requirements.
How do regulatory exports work?
Certivo one-click regulatory export generates a complete compliance package including full audit trail with hash-chain verification, document access logs, GDPR Article 30 processing records, and retention settings. Exports are available filtered by date range, workflows, or requesting authority (FDA, MHRA, EMA).
Can guest users sign without an account?
Yes! Recipients receive a secure signing link via email and can sign documents without creating an account. All signature events are fully audited with IP address, timestamp, and device information for complete regulatory compliance.
Is my data secure?
Absolutely. Certivo uses bank-level encryption (TLS 1.3 in transit, AES-256 at rest) with multi-tenant data isolation. All passwords are hashed with bcrypt, and we support two-factor authentication. Documents are verified with SHA-256 hash integrity checks.