SOPs in shared drives.
Version control by filename.
Every document versioned, every signature captured, every change tracked.
Every document versioned, every signature captured, every change tracked.
The problem
SOPs live in shared drives with "v2_final_FINAL" naming conventions
Approvals tracked via email threads or printed sign-off sheets
No reliable record of who changed what, when, or why
Auditor asks for document history - team scrambles to reconstruct it
The solution
Automatic version numbering, draft/review/approved lifecycle, obsolete handling
Electronic signatures with meaning, timestamp, and identity verification
Every view, edit, approval, and download recorded with ALCOA+ compliance
Document changes automatically trigger training assignments and acknowledgments
Replaces shared drives and manual tracking with a controlled document repository
Import existing documents, assign document types and owners
Define review and approval chains for each document type
Draft, review, approve, distribute, and retire with full traceability
Periodic review reminders, expiry alerts, and instant evidence retrieval
To retrieve any document history
Signature traceability
Uncontrolled document copies
Audit-ready
Needs controlled documents with complete audit trails for ISO 13485
Need a simple workflow for creating, reviewing, and approving documents
Need to verify document control processes meet regulatory requirements
Complete document control with 21 CFR Part 11 compliance - configured in 21 days.