Controlled documents, e-signed and version-locked the way an inspector expects.
Document Management governs the full lifecycle of SOPs, batch records and controlled forms — draft, review, approval, effective date, periodic review, retirement — with every step captured in an audit trail and every signature legally attributable under Part 11.
Document control is where Part 11 meets everyday GMP.
Almost every other module depends on this one — a batch record, a CAPA, a training assignment are all, underneath, controlled documents or records governed by the same rules.
Controls for Closed Systems
Requires validation, the ability to generate accurate copies, protection of records, and — critically — secure, computer-generated, time-stamped audit trails for created, modified or deleted electronic records.
Signature Manifestations
Requires an electronic signature to display the signer's name, the date and time of signing, and the meaning associated with it — approved, reviewed, or responsible for.
Records and Reports
Sets retention periods and availability requirements for production, control, and distribution records — the system of record this module is built to be.
Computerised Systems
Parallels Part 11's expectations on audit trails, access control and electronic signature integrity for EU-regulated sites.
Every controlled document, one system of record.
Version confusion is one of the most common findings in an FDA 483. The software is built specifically to make it structurally impossible.
Only one version is ever current
Superseded versions are locked and clearly marked — nobody on the floor can accidentally work from an outdated SOP.
E-signatures built to §11.50
Review, approval and effective-date actions are signed with name, timestamp and stated meaning captured automatically.
Training reopens itself
Revising a document automatically reopens the training assignment for every user whose curriculum includes it.
Full-text search across everything
Find any SOP, form, or batch record by content, not just by document number — useful in daily work and indispensable during an audit.
See document control from draft to effective date.
We'll show the full review-approve-effective workflow, e-signatures, audit trail and automatic training reopen using one of your own SOPs as the example.