Everything you need for compliance.
A unified platform replacing paper logs, binder-based SOPs, manual temperature readings, and spreadsheet-driven training records.
Real-time monitoring, automated excursion alerts.
Real-time sensor data ingestion from SafetyCulture, Monnit, SensorPush, and Dickson loggers. Automatic zone classification enforcement for ISO 5, 7, and 8 cleanrooms.
- 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)
- 5-day sensor qualification testing checklists
Version-controlled SOPs with 21 CFR Part 11 e-signatures.
Manage every SOP with full version history and a three-signature approval workflow: author, reviewer, approver. Pre-loaded USP templates get you started.
- Rich text editing with Tiptap editor
- 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
Every action logged. Every signature verified.
21 CFR Part 11 compliant electronic records with signature hash verification for tamper detection.
- 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.
Weighted compliance scoring across 8 categories. See your facility through an FDA inspector's lens and identify gaps before they do.
- 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 tracker with 15-business-day deadline countdown
- Inspection document index with completeness tracking
Track reclassified peptides from status change to SOP.
Track Category 1/2 status for reclassified peptides, manage Certificates of Analysis, and deploy peptide-specific SOP templates.
Compliance standards we cover.
The USP chapters, FDA requirements, and accreditation standards CompliRx tracks.
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)
See it in action.
Book a demo to see how CompliRx simplifies compliance for your facility.