Batch and compounding records
Execute compounding with step-level documentation, ingredient tracking, pharmacist review, and 21 CFR Part 11 electronic signatures.
503B outsourcing facilities
Compliance operations software for 503B outsourcing facilities
A 503B facility answers to cGMP expectations: documented batch execution, a monitored environment, calibrated equipment, controlled procedures, and a deviation and CAPA program with real follow-through. CompliRx provides the operational record system underneath those expectations.
Batch documentation assembled from paper travelers and spreadsheets
Environmental monitoring data reviewed retrospectively instead of continuously
Calibration and maintenance evidence tracked per instrument, not per program
Deviations closed without connected evidence or effectiveness review
One workflow from signal to source record
Environmental monitoring program
Run continuous room monitoring plus viable air, surface, and personnel sampling with trending, excursion handling, and investigations.
Equipment and calibration
Track calibration schedules, certificates, maintenance, and certification records with due-date visibility across the facility.
Quality system records
Control SOPs and documents, manage deviations and CAPA with owners and effectiveness checks, and retrieve evidence quickly during FDA inspection.
What facilities gain
- Batch history retrievable with attribution and review signatures
- A monitoring program with documented follow-through
- Calibration status visible before it becomes a finding
- Deviation-to-CAPA traceability that holds up under inspection
Related compliance workflows
Run CompliRx for $399/month.
The 90-day pilot includes guided onboarding and configuration around how your facility actually operates.