USP Purified Water · Self-assessment
Will Your Water System Survive an FDA Audit?
A 36-question diagnostic built from nearly 20 years in FDA-regulated plants, including designing, validating, and operating USP Purified Water systems. Find your gaps before the investigator does.
One-time purchase · instant results
What you'll get
A gap report you can act on this week.
The same assessment framework Claraxis Group uses in on-site water system audits, now self-serve.
- Section-by-section gap reportAcross all 11 audit domains, from the design package to microbial excursions.
- FDA observation risk ratingFlags on your weakest areas, with the regulation investigators typically cite.
- Your Water System Readiness ScoreOne number from 0 to 100, with a clear band: Audit-Ready, Gaps to Close or At Risk.
- The top 5 findings in plain languageWhat's wrong, and why FDA cares about it.
- Prioritized next stepsWhat to close first, in order, so your team works on what matters.
The 11 audit domains
Every place an investigator looks.
- Documentation & Design Package
- Incoming Water & Pretreatment
- Treatment Train
- Storage & Distribution
- Materials & Fabrication
- Sanitization Strategy
- Monitoring & Trending
- Validation (DQ/IQ/OQ/PQ)
- Maintenance & Calibration
- SOPs & Training
- Microbial Control & Excursions
1Get access. Complete checkout. Your personal access code arrives by email.
2Answer 36 questions. One per screen, about 15 minutes. Answer from what you can prove with records.
3Get your report instantly. Score, heatmap, top findings and next steps. Print it or save it as a PDF.
Your answers stay in your browser. Only your access code is checked by our server.
Already paid? Enter your access code.
Your personal access code is emailed after purchase, usually within one business day.
No code yet? Get access · Questions? [email protected]