Klyverity - E-Signatures for FDA-Regulated Trials

FDA-compliant e-signatures for clinical trials and life sciences

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Updated Jul 2026 · Added Jul 2026

klyverity.com

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What is Klyverity?

Klyverity is a secure e-signature platform purpose-built for clinical trials, pharmaceuticals, and life sciences organizations. It delivers FDA 21 CFR Part 11, EU CTR 536/2014, and GDPR compliance with 25-year document retention and ALCOA+ audit trails. The platform streamlines regulatory document signing through a three-step workflow: upload documents, add signers with sequential or parallel routing, and track completion with full audit trails. Designed for teams managing clinical protocols, site agreements, and delegation logs that require strict regulatory oversight.

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Key Features of Klyverity

FDA 21 CFR Part 11 compliance with validation documentation
ALCOA+ audit trails with hash-chain verification
25-year document retention for EU CTR 536/2014
Two-factor authentication (TOTP-based)
Sequential and parallel signing workflows
Automated reminders and deadline management
One-click regulatory export packages
Immutable audit trail capturing who, what, when, where, why
GDPR compliant processing
UK MHRA 2026 ready

Who Should Use Klyverity?

Manage electronic signatures for clinical trial documents

Ensure FDA compliance for pharmaceutical records

Maintain ALCOA+ data integrity for regulated trials

Export compliance packages for FDA, MHRA, or EMA inspections

Track delegation logs with complete audit trails

Manage site agreements with automated workflows

Klyverity: Pros & Cons

✓Pros

Purpose-built for clinical trials and life sciences with deep regulatory compliance
One-click compliance packages ready for FDA, MHRA, EMA inspections
Immutable hash-chain audit trails meeting ALCOA+ standards
Flexible workflow routing (sequential or parallel)
Automated reminders and deadline management
25-year document retention guaranteed
Enterprise-grade security with 2FA