USP 797 compounding pharmacy

The full workflow

1. STEP 01Client onboarding — each pharmacy client is set up with facility locations, cleanroom floor plans, and sample location maps. ISO class assignments are configured per location. Monitoring schedules (weekly, biweekly, monthly) generate a 12-month occurrence calendar automatically.
2. STEP 02Chain of custody — when a sampling event is due, the pharmacy’s QA manager creates and submits a CoC digitally from their portal. Customer info auto-populates. Sample locations are selected from the mapped floor plan — no free-text. Media lot and air sampler calibration data are captured.
3. STEP 03Sample receipt & processing — lab staff are notified when the CoC is submitted. The lab-side view includes additional fields for internal documentation. Technicians enter CFU counts, incubation parameters, and organism IDs for samples with growth. Plate images upload directly to the record.
4. STEP 04Alert / action level evaluation — every sample is automatically evaluated against the configured thresholds for its ISO class. Results are flagged in real time — no manual threshold lookup required.
5. STEP 05Report generation — one click generates the full PDF. Reports include: results summary with alert/action status, organism descriptions, plate images, trending section with z-scores and charts, facility floor plan, and electronic signatures from the lab director and QC manager.
6. STEP 06Review & approval — reports enter Under Review. A lab director approves with electronic signature. If corrections are needed, the report is rejected back to the technician. Full version history is maintained.
7. STEP 07Client report access — when a report is approved and published, the pharmacy client receives an instant notification. They log in, view, download, and can leave comments.