Module-aware CAPA creation
Open or edit a CAPA loop from environmental monitoring, personnel, equipment, cleaning, and other operational modules while retaining source context.
Quality operations
CAPA software for compounding pharmacies
A CAPA is useful only when the signal, investigation, action, and effectiveness evidence remain connected. CompliRx lets pharmacy teams open a CAPA from the affected module, preserve its source context, assign follow-through, and review whether the action produced the intended result.
Excursions and failed results disconnected from their investigation
Corrective actions recorded without an owner or due date
CAPA logs that do not link back to environmental or personnel evidence
Closed actions without a documented effectiveness review
Quality operations: supported workflows
Investigation and ownership
Document the event, root cause, risk, action plan, responsible owner, due dates, and supporting records.
Automated signals
Use configured triggers to surface qualifying excursions, failures, and recurring conditions for review without auto-closing professional judgment.
Effectiveness follow-through
Schedule and document effectiveness checks, review subsequent evidence, and retain the decision trail.
What facilities gain
- Traceability from source event through final review
- Clear ownership and due-date visibility
- Evidence linked to the action it supports
- A defensible effectiveness record instead of a closure checkbox
Follow an excursion through investigation and effectiveness review
A recurring room excursion may need immediate containment, an investigation and a later check that the chosen action worked. Closing the alert is only one event in that sequence.
- Link the source event, record the immediate response and assign an investigation owner.
- Document the assessed cause, action plan, responsible person and due date with supporting evidence.
- Define the effectiveness measure and review interval, then record the follow-up evidence and decision.
For operations subject to drug CGMP, 21 CFR 211.192 requires investigation of unexplained discrepancies and specification failures, with written conclusions and follow-up. Pharmacy quality programs should use the requirements applicable to their operation; 503A and 503B are not interchangeable regulatory categories.
Primary references: 21 CFR 211.192: Production record review · USP <1163>: Quality Assurance in Pharmaceutical Compounding
Quality operations: common questions
What is the difference between a correction and corrective action?
A correction addresses the immediate condition. Corrective action addresses an investigated cause to reduce recurrence. A useful record distinguishes the immediate response, the cause assessment and the evidence used to evaluate the longer-term action.
Can CompliRx decide the root cause automatically?
Configured signals can identify events for review. Qualified personnel evaluate the evidence, determine the cause and approve the action. Effectiveness monitoring supports their review; it does not replace that decision.
Related compliance workflows
Run CompliRx for $399/month.
The 90-day pilot includes guided onboarding and configuration around how your facility actually operates.