Six controls
What ships. Configuring and validating them for your intended use stays with you.
Document control
Controlled authoring, review, and approval, with superseded versions retained rather than deleted.
Audit trail
A secure, computer-generated, time-stamped record of who changed an entry and when, without overwriting the prior value.
Electronic signatures
Identity, meaning, and timestamp, permanently bound to the record they authenticate.
Access control
Unique credentials and role-based permissions over who can create, modify, or approve a record.
Training records
Required reading and role-based curricula, each completion tied to the exact document version.
Change control & CAPA
Deviations, CAPAs, and change requests on configurable workflows, traceable to what triggered them.