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Company description

Certivo is an electronic signature platform built specifically for life sciences organizations, including clinical research sites, pharmaceutical companies, medical device manufacturers, and laboratory systems. The platform is designed to meet the requirements of FDA 21 CFR Part 11, EU Clinical Trial Regulation 536/2014, UK MHRA 2026, GDPR, and EU GMP Annex 11, providing legally binding electronic signatures with full regulatory compliance built into the core product.

Certivo supports a three-step document signing workflow: users upload a PDF and add signature fields, initials, dates, and custom form fields; add recipients with sequential or parallel routing and deadline reminders; and then monitor signing progress in real time before downloading completed documents with full audit trails. Guest recipients can sign via a secure email link without creating an account, with all signature events captured for regulatory purposes.

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 document retention to support long-term safety monitoring and regulatory access
• UK MHRA 2026 clinical trial requirements
• GDPR Article 30 records of processing activities
• EU GMP Annex 11 requirements for computerized systems
• ALCOA+ data integrity principles: Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available

Core Platform Features

• Immutable hash-chain audit trails capturing 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
• Sequential or parallel signing workflows with automated reminders and deadline management
• 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, filterable by date range, workflow, or requesting authority
• Archive management with named individual responsibility
• Guest signing via secure email link, with IP address, timestamp, and device information captured for each signature event
• Validation documentation included with the platform

Industries and Use Cases Served

• Clinical Research: informed consent forms, clinical protocols, site agreements, and delegation logs
• 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 laboratory logs

Security and Infrastructure

• AES encryption and TLS 1.3 for data security
• Bank-level encryption standards applied across the platform
• Uptime SLA provided for enterprise reliability
• Document storage designed to meet long-term regulatory accessibility requirements

Certivo publishes a blog covering regulatory topics including FDA 21 CFR Part 11 compliance guides, audit trail requirements, FDA inspection readiness, and buyer's guidance for selecting compliant e-signature software. A 14-day free trial is available with no credit card required, and validation documentation is included.

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Software attributed to Certivo

• Electronic Signature PlatformView

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