Compounding pharmacy compliance software features.
Explore the work CompliRx supports, the records it preserves and the workflows to verify during a pilot. Your team approves procedures and validates the configured system before replacing controlled records.
Real-time monitoring, automated excursion alerts.
Sensor integrations for SafetyCulture, Monnit and SensorPush, plus CSV import for Dickson logger data. Associate readings and configurable limits with the correct room; the software does not physically certify an ISO classification.
- Temperature, humidity, and differential pressure monitoring
- Automated excursion detection with configurable thresholds per zone
- Statistical Process Control (SPC) trend analysis
- Sensor health monitoring (battery, connectivity, heartbeat)
- Sensor qualification checklists configured to your approved protocol
Version-controlled SOPs with attributed review and approval.
Manage every SOP with full version history and a three-signature approval workflow: author, reviewer, approver. Pre-loaded USP templates get you started.
- Controlled authoring with version history
- Employee acknowledgment tracking with read-time monitoring
- Pre-loaded USP <797>/<800> SOP templates
- Department-specific distribution and notification
- Full audit trail: who created, reviewed, approved, acknowledged
Review electronic attribution and record history.
Electronic signatures, record history and integrity checks support your electronic-record controls. Applicability, validation, access management and staff procedures remain part of your assessment.
- Password re-authentication at time of signing
- User agent and IP logging for forensic analysis
- One-click FDA inspection report packages
- Environmental trend reports over configurable date ranges
- Scheduled report execution (daily, weekly, monthly)
Qualified personnel, tracked automatically.
USP <797> training requirement templates with competency tracking. Qualification profiles gate task pool access, so only qualified personnel can claim specific tasks.
- Training assignment to individuals or teams with bulk assignment
- Media fill, garbing, and aseptic technique competency tracking
- Credential tracking with expiration dates and renewal workflows
- Training compliance matrix showing team-wide status
- Auto-assignment rules for new hires
Centralized document storage with metadata tagging.
Centralized document storage with metadata tagging, hierarchical organization, and equipment document linking.
- Document upload with categorization
- Template library for common pharmacy documents
- In-app inbox with inbound email integration
- Document assignment for team review
Calibration tracking with NIST traceability.
Equipment inventory organized by facility zone with maintenance scheduling, calibration tracking, and NIST traceability documentation.
- Maintenance scheduling and logging with history timeline
- Calibration certificate upload and tracking
- Calibration due date reminders and overdue alerts
- Equipment-to-document linking (manuals, certificates, SOPs)
Daily compliance scoring and mock inspections.
Use internal indicators to prioritize missing evidence across eight categories, then inspect the underlying record. A software score is not an FDA assessment or a prediction of inspection results.
- Compliance score: 0 to 100 with letter grades across 8 categories
- FDA 6-system inspector view with pass/warning/fail assessment
- 40-item mock inspection checklists with auto-assessment
- Form 483 response planning with a configurable review workflow
- Inspection document index with completeness tracking
Connect substance review, supplier evidence and SOPs.
Retain substance-status review, Certificates of Analysis and supplier evidence with the applicable procedure. Verify current FDA eligibility separately for 503A and 503B operations.
Map workflows to the requirements that apply.
These frameworks have different scopes. Your jurisdiction, facility type and intended use determine the applicable requirements.
Sterile compounding standards for cleanroom operations
Non-sterile compounding requirements
Hazardous drug handling and safety
Electronic records and signatures
Current Good Manufacturing Practice (cGMP)
FDA inspection readiness for 503B facilities
Model Standards for pharmacy compounding of sterile and non-sterile preparations (Canada)
Find the workflow and its supporting guidance
What to establish before rollout
- Map facility areas, users, devices, approved procedures and record ownership.
- Test representative work: capture a result, review an exception, sign an approval and retrieve the original evidence.
- Agree migration scope, retention, access permissions, training and acceptance criteria before retiring an existing process.
Does every pharmacy record fall under Part 11?
No blanket assumption is appropriate. FDA’s scope guidance addresses electronic records under applicable FDA requirements. Use our electronic-record assessment guide to frame the review.
How can I verify a feature for my facility?
Bring a sample workflow to a guided demonstration. Confirm your devices on the integration page, inspect the security controls, and compare published product changes with what you need. Confirm scope and acceptance criteria in writing.
See it in action.
Book a demo to see how CompliRx simplifies compliance for your facility.