Use Case
E-Signatures for Life Sciences & Pharma
Meet regulatory expectations with immutable WORM storage, hash-chained audit trails, and identity verification designed for FDA 21 CFR Part 11-conscious workflows.
Challenges life sciences organizations face
⚠ FDA regulatory requirements
21 CFR Part 11 demands electronic signatures with audit trails, signer authentication, and tamper-evident records. Standard e-signature tools often lack the evidentiary depth regulators expect.
⚠ Clinical trial consent complexity
Informed consent for clinical trials requires proof that participants understood the protocol, risks, and alternatives — across multiple languages and jurisdictions.
⚠ Document integrity for inspections
FDA inspections and sponsor audits require demonstrable document integrity. If records can be silently altered after signing, the entire submission is at risk.
How Abundera Sign supports life sciences workflows
✓ Immutable WORM storage
Every signed document is sealed in write-once immutable storage with configurable retention. Once sealed, evidence packages cannot be modified — supporting 21 CFR Part 11 integrity requirements.
✓ SHA-256 hash-chained audit trails
Every event — created, viewed, signed, sealed — is recorded in a hash-chained audit trail. Each entry includes IP address, user agent, and timestamp. Tampering with any entry invalidates the chain.
✓ Identity verification layering
Access codes, SMS OTP, government ID verification, and knowledge-based authentication. Layer the appropriate controls for each document type — from routine NDAs to clinical trial consent.
✓ Signing ceremony evidence
Behavioral evidence of informed consent — page views, reading time, scroll depth, and field interactions. Signer evidence scoring quantifies the strength of each signing ceremony for regulatory review.
✓ Dual RFC 3161 timestamps
Every sealed document receives dual RFC 3161 trusted timestamps from independent certificate authorities. Cryptographic proof of when the document existed — not just a server clock entry.
✓ Multi-language support
Signing pages, emails, and certificates in 20 languages. AI document summaries help participants understand complex protocols before signing — critical for international clinical trials.
Ready-to-use life sciences templates
Build regulatory-ready evidence packages
Try the full signing experience — no account needed. See WORM-sealed documents, hash-chained audit trails, and cryptographic proof.