The Cost of Missing Ongoing Review & Maintenance Strategy
During a project in a Pharma South American company, the PW system was validated three years ago — and never reassessed. The system was no longer in the validated state, even though the documents said it was.
Why Systems Degrade Over Time
- No periodic requalification
- No preventive maintenance
- No historical trending (TOC, CFU, temperature, pressure)
- No annual assessment of validated status
- Maintenance became reactive
The result? System unpredictability — and rising risk.
Self-Diagnostic — Lifecycle Health Check
Question Yes/No
- Do you requalify after 2–3 years of operation?
- Do you have trending over >12 months?
- Is maintenance preventive or reactive?
- Is system performance reviewed annually?
Regulatory Insight
Source Expectation
- EMA Annex 15 Periodic review must confirm validated state
- FDA CSA Lifecycle-based strategy recommended
- PIC/S PI-006 Lack of lifecycle approach = critical finding
Action Plan
- ✔ Implement periodic requalification
- ✔ Use trending dashboards (TOC, CFU, temperature)
- ✔ Convert maintenance to preventive strategy
- ✔ Annual validation reassessment required
Leadership Insight
Validation is achieved once.
Compliance is maintained forever.
