Electronic Signature Platform

Certivo is an electronic signature platform built specifically for life sciences organizations operating under regulated environments. It targets clinical research sites, pharmaceutical quality assurance teams, medical device manufacturers, and laboratory systems that require validated, compliant electronic signature workflows. The platform is designed to meet FDA 21 CFR Part 11, EU CTR 536/2014, UK MHRA 2026, GDPR, and EU GMP Annex 11 requirements.

Certivo supports legally binding electronic signatures with ALCOA+ audit trails, two-factor authentication, and 25-year document retention. It is positioned as a purpose-built solution for organizations that need to demonstrate compliance readiness for FDA, EMA, and MHRA inspections.

Regulatory Compliance Coverage

• FDA 21 CFR Part 11 compliance for electronic records and electronic signatures, including validation documentation and IQ/OQ protocols
• EU CTR 536/2014 Article 58 compliance, requiring 25-year retention of clinical trial master files after trial completion
• UK MHRA 2026 clinical trial requirements
• GDPR Article 30 records of processing activities
• EU GMP Annex 11 computerized systems requirements
• ALCOA+ data integrity principles: Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available

Core Features and Capabilities

• Immutable hash-chain audit trails that capture who, what, when, where, and why for every action, meeting ALCOA+ requirements
• 25-year document retention with guaranteed accessibility, compliant with EU CTR Article 58
• Two-factor authentication using TOTP-based 2FA with backup codes
• One-click regulatory export packages for FDA, MHRA, or EMA inspections, including full audit trails, document access logs, GDPR Article 30 processing records, and retention settings; exports can be filtered by date range, workflow, or requesting authority
• Sequential or parallel signing workflows with automated reminders and deadline management
• Archive management with named individual responsibility
• GDPR Article 30 records of processing activities maintained within the platform
• SHA-256 hash integrity checks for document verification
• TLS 1.3 encryption in transit and AES-256 encryption at rest, with multi-tenant data isolation and bcrypt password hashing
• Guest signing via secure email link, without requiring recipients to create an account; all signature events are audited with IP address, timestamp, and device information

Document Signing Workflow

1. Upload a PDF document and add signature fields, initials, dates, and custom form fields
2. Add recipients with sequential or parallel routing, set signing order, and configure deadline reminders
3. Monitor signing progress in real-time and download completed documents with full audit trails

Supported Use Cases by Industry Segment

• Clinical Research: informed consent forms, protocols, and site agreements
• Pharmaceutical QA: batch records, standard operating procedures, and deviation reports
• Medical Devices: design history files and validation protocols
• Laboratory Systems: test results, method validation records, and logs

Certivo includes validation documentation as part of its standard offering, with IQ/OQ protocols provided to support regulated system qualification. The platform is available via a 14-day free trial with full validation documentation included and does not require a credit card to start.