Compliant Sign-Off, Built Into the Workflow.
Printing a document just to sign it and scan it back is a workflow that belongs to a different era. Our e-signature module is embedded directly inside your pharmaceutical processes — from batch record review to CAPA closure — so approvals happen where the work happens, with a full audit trail automatically captured.
A wet signature on a PDF is not an audit trail.
The FDA's 21 CFR Part 11 regulation is clear: electronic signatures must be unique to the individual, verifiable, and linked to the record they sign. A scanned signature image does not meet this standard. Neither does typing your name into a form field without identity verification.
Our e-signature engine requires PIN-based identity verification at the point of signing, records the meaning of the signature (review, approval, or authorship), and stores the timestamp alongside the record it is associated with.
This is not a bolt-on feature. It is embedded into every workflow that requires a controlled approval — batch records, CAPA sign-off, change control, and SOP review.
Each e-signature must be unique to the individual and not reused by or reassigned to anyone else.
Non-biometric e-signatures must use at least two distinct identification components, such as user ID and password or PIN.
Signed records must display the printed name of the signer, date and time of signing, and the meaning of the signature.
Electronic signatures must be linked to their respective electronic records to ensure signatures cannot be excised, copied, or otherwise transferred.
Embedded approval at every critical step.
PIN-Based Identity Verification
At the point of signing, the user enters their unique PIN. This is separate from their login credentials and tied specifically to the act of signing — meeting §11.200 requirements.
Signature Meaning Captured
Each signature captures the role and meaning — Reviewed, Approved, or Authored — displayed directly on the signed record. Reviewers know exactly what each signature represents.
Immutable Timestamp
Every signature is recorded with server-side timestamp that cannot be modified after the fact. The date, time, and user identity are permanently attached to the signed record.
In-Record Audit Trail
Auditors can view the complete signature history of any record — who signed, when, in what role — without needing to check a separate log. The record is self-contained and traceable.
Multi-Step Approval Chains
Define sequential approval workflows where each step requires sign-off before the next reviewer is notified. Configurable to match your existing SOP approval processes exactly.
Rejection with Reason
Reviewers can reject a record and provide a written reason. The rejection is logged in the audit trail, and the record is returned to the author for correction — keeping the process traceable.
E-signature works across all our modules.
Ready to retire the print-sign-scan cycle?
We'll walk you through our e-signature implementation and show how it integrates with your existing approval workflows.
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