Highlight Features
Built for regulated signing.
Re-Authentication
Signers authenticate to open and review the document, then re-authenticate each time they apply a signature.
Signing Reason
Every signature records its meaning, such as author, reviewer and approver.
Extensive Audit Trail
All signing events, e.g. uploads, placements, signatures, declines, voids etc., are time-stamped and exportable for inspections.
Sign Specific Blocks
Link a signature to an exact section of content, not only the document as a whole.
No Bulk Signing
Each signature is applied individually at its required location.
Locked Signed Records
Signed documents cannot be edited. Any change requires a new signature cycle.
Compliance
Compliant by Design.
Designed around the regulations life-science manufacturers are inspected against, so your signed records stand up to audit.
FDA 21 CFR Part 11
Signature manifestation with name, date, time and meaning. Signatures linked to their records.
EU GMP Annex 11
Controlled access with double authentication, audit trails for GMP-relevant changes and signatures permanently bound to their records.
ALCOA+ Data Integrity
Attributable, Legible, Contemporaneous, Original and Accurate records that are also Complete, Consistent, Enduring and Available.
Deployment
Use it on its own, or connect it to everything.
OneESIGN is built to work standalone, alongside other OneSC products, or inside the tools your teams already use.
Standalone
Sign without a platform subscription.
Upload controlled documents, send them for signature and keep the audit trail, with no other OneSC product required.
OneSC Ecosystem
Built into OneSC workflows.
Sign order, batch and shipment records where they are created, with signatures and audit trails kept alongside the batch.
Your Existing Tools
Integrates with the systems you run.
Connect OneESIGN to your document management, QMS and ERP systems through the API and webhooks.