Validation & Qualification
Documented evidence the process consistently makes conforming product — and the systems behind it.
Validation is documented evidence that a process, operated in a defined range, consistently produces conforming product; qualification proves the facility, equipment, and computerised systems support it. Gaps here are patient-safety gaps, so they draw intense inspection scrutiny — and the modern expectation is a lifecycle, not a one-time three-batch event.
The observable evidence a practitioner — or an inspector — would expect at each maturity level. Drawn from the assessment questions themselves.
How is your equipment and process validation program structured?
Validation performed on an ad hoc basis when required
Validation Master Plan exists; coverage is incomplete
Comprehensive VMP with defined scope, risk-based approach, and revalidation triggers
Lifecycle validation model per ICH Q8/Q9/Q10; continued process verification in place
Continuous process verification with PAT / real-time release; the validation lifecycle self-optimises against live process data
How are computer systems validated (CSV/CSA)?
No formal CSV program; systems used without validation
Critical systems validated; program lacks consistency and inventory
Risk-based CSV program with system inventory, validation plans, and periodic reviews
CSA approach aligned with ISPE GAMP5 (2022); data integrity controls documented and audited
Continuous assurance: automated risk-based testing, live data-integrity monitoring, and audit-by-exception across the system landscape
- ›Processes in routine commercial use without current, completed validation; no Continued Process Verification.
- ›Validation Master Plan absent or incomplete; revalidation triggers undefined.
- ›Computerised systems used without validation, or with audit trails disabled or never reviewed.
- ›Acceptance criteria set after the fact, or not justified by process understanding (ICH Q8).
Recent FDA recalls whose reason SPEQ maps to this domain — a SPEQ editorial interpretation of the recall reason, not an official FDA classification.