Environmental monitoring
Track room conditions, viable sampling, alert and action levels, incubation status, and investigation evidence.
USP <797> operations
USP <797> compliance software for compounding pharmacies
CompliRx brings the records behind sterile compounding into one facility-scoped system. It helps teams perform scheduled work, identify missing evidence, and retrieve the underlying record without treating software as a substitute for the pharmacy’s policies or professional judgment.
Cleaning records split between paper and spreadsheets
Qualification results that do not show incubation timing clearly
Environmental excursions discovered during retrospective review
Supporting files stored separately from the record they substantiate
USP <797> operations: supported workflows
Personnel qualification
Record fingertip, garbing, media-fill, and related assessment results with temperature-specific incubation profiles.
Cleaning and recurring work
Generate facility work by cadence with duplicate prevention, completion attribution, and audit history.
Inspection retrieval
Move from a compliance indicator to the facility area, employee, equipment item, or source record that requires attention.
What facilities gain
- A single facility record instead of disconnected binders
- Earlier visibility into missing or overdue evidence
- Electronic attribution and retained audit history
- Faster retrieval during internal review and inspection preparation
Review a sterile-compounding shift from the underlying evidence
A manager reviewing a buffer room needs to know which work was completed, which results are pending, and which exceptions still need a decision. A single green percentage cannot answer those questions.
- Review room readings and sampling results alongside pending incubation and open exceptions.
- Check that the people assigned to compound have the required qualification evidence; course completion and practical assessment remain separate records.
- Retrieve cleaning completions, equipment certificates and the applicable SOP, then assign follow-up to the missing record.
USP <797> addresses sterile compounding. Its requirements must be translated into the facility’s procedures and responsibilities; a software status does not establish that a preparation is suitable for release.
Primary references: USP: General Chapter <797> · USP <1163>: Quality Assurance in Pharmaceutical Compounding
USP <797> operations: common questions
Does CompliRx make a pharmacy USP <797> compliant?
CompliRx organizes work and evidence. Your designated personnel establish applicable requirements, approve procedures, evaluate results and make compounding decisions. Use the pilot to review your actual room, personnel and record workflows against those requirements.
How does this differ from the environmental monitoring module?
This page covers the overall sterile-compounding operation. Environmental monitoring handles room conditions and samples; the wider workflow also includes personnel qualifications, cleaning, equipment and controlled documents.
Related compliance workflows
Run CompliRx for $399/month.
The 90-day pilot includes guided onboarding and configuration around how your facility actually operates.