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
For designated persons, pharmacists and technicians who run sterile compounding in 503A pharmacies, 503B outsourcing facilities and hospital IV rooms. CompliRx turns your approved USP <797> procedures into scheduled monitoring, cleaning and qualification work, keeps SOPs and equipment records current, and links each exception to its follow-up. Your pharmacy still sets the requirements; the software organizes the work and the evidence.
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.
Equipment and PEC certification
Keep hood and biosafety cabinet certification reports, calibration and maintenance due dates on each equipment record, with reminders before they lapse.
SOP control and CAPA
Route SOP revisions through review and approval with password-confirmed signatures and staff acknowledgment. Action-level results can open a CAPA under your facility’s policy.
Inspection retrieval
Move from a compliance indicator to the facility area, employee, equipment item, or source record that requires attention.
How USP <797> work areas map to CompliRx records
The frequencies, limits and responsibilities come from your approved procedures. CompliRx records the work against them.
| Work area | What CompliRx records | Example |
|---|---|---|
| Personnel training and evaluation | Role- and function-based training assignments; garbing, gloved-fingertip and media-fill runs with incubation profiles and results. | A technician’s media-fill plates appear on the incubation board with their earliest read time; the result sets the next due date. |
| Viable air and surface sampling | Sampling sessions by location, incubation phases, CFU reads and alert or action levels for each sample type. | An action-level surface result opens a CAPA if your facility policy calls for one. |
| Room conditions | Sensor readings for temperature, humidity and pressure by room; offline alerts; manual backup readings with observed and entered times. | Differential pressure stays below the room’s limit long enough to raise an alert; staff acknowledge and document it, and the excursion stays in the room history. |
| Cleaning and disinfecting | Daily, weekly, monthly and yearly checklist items per room and PEC, generated from templates, with who did the work, when, and the products used. | A monthly ceiling and wall clean remains a separate item from the daily floor clean, even on the same day. |
| Equipment and PECs | Certification reports, calibration and maintenance history with due dates for hoods, cabinets, refrigerators and incubators. | A reminder goes out before an incubator’s calibration is due, and the completed calibration is logged on that item. |
| Investigations and CAPA | Corrective and preventive actions with root-cause method, owners, due dates, reviewer approval and an effectiveness check, linked to the excursion or finding that opened them. | A failed hood certification opens a CAPA; the recertification report and effectiveness check are recorded against it. |
| SOPs and documentation | Versioned SOPs with author, reviewer and approver, effective dates, superseded editions and staff acknowledgments. | When reviewing a past cleaning record, retrieve the SOP edition that was effective on that date. |
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.