Version and lifecycle control
Maintain draft, active, approved, expired, and superseded states with effective dates, expiration dates, and preserved version history.
Controlled documents
Document control software for compounding pharmacies
CompliRx gives pharmacy documents an operational lifecycle instead of treating them as files in a folder. Effective dates, expiration dates, approval status, versions, acknowledgments, linked records, and replacement history remain visible from the document itself.
Expired certificates without a clear renewal action
Current and superseded versions mixed in shared folders
SOP acknowledgments tracked separately from the controlled edition
Inspection evidence that cannot be traced back to its source record
Controlled documents: supported workflows
Renew or replace in context
Upload a renewed version with a new expiration date or link an existing current document as the replacement from the overdue record.
SOP approval and acknowledgment
Coordinate controlled SOP versions, approval signatures, release, staff acknowledgment, and training links.
Connected evidence
Attach documents to equipment, qualifications, sampling, deviations, CAPAs, and other facility records so reviewers can move from indicator to proof.
What facilities gain
- A clear current edition for each controlled document
- Actionable expiration and renewal workflows
- Preserved supersession and acknowledgment history
- Faster retrieval of source evidence during reviews
Trace an SOP change from approval to staff acknowledgment
When a cleaning SOP changes, reviewers need the effective edition, the superseded edition and the staff response to the change—not just the latest uploaded PDF.
- Create the revised version with its change summary and route it through the configured review and approval workflow.
- Retain effective dates and version history, and associate staff acknowledgment or training with the applicable edition.
- Retrieve that edition alongside the cleaning, equipment or quality record it supports; renew expiring certificates from their existing document context.
USP <1163> describes written procedures, documentation and assigned responsibilities as components of compounding quality assurance. FDA’s Part 11 guidance addresses electronic records in scope; having electronic signatures alone does not establish a validated compliant implementation.
Primary references: USP <1163>: Quality Assurance in Pharmaceutical Compounding · FDA: Part 11 scope and application guidance
Controlled documents: common questions
How is document control different from a shared folder?
A folder stores files. Document control also tracks the edition, approval, effective date, replacement history and acknowledgment. CompliRx makes those lifecycle details available from the document record.
Should we delete the old SOP after a revision?
Preserve superseded versions according to your retention procedure so past records can be interpreted against the procedure in effect at the time. The current edition should remain clearly identifiable.
Related compliance workflows
Run CompliRx for $399/month.
The 90-day pilot includes guided onboarding and configuration around how your facility actually operates.