Documentation & Change Control
Controlled records and a change process that keeps a validated state validated.
Records are the evidence a regulated operation ran as intended, and change control is how a validated state survives change. When either fails, an inspector cannot trust anything downstream — which is why uncontrolled documents and unassessed changes are among the most frequently cited GMP deficiencies. This domain is the connective tissue of the whole quality system.
The observable evidence a practitioner — or an inspector — would expect at each maturity level. Drawn from the assessment questions themselves.
How are your quality documents controlled and version-managed?
No formal system — printed copies, email distribution
Documented SOPs exist but reviews are ad hoc
Formal DMS with scheduled review cycles and training records
Validated electronic DMS with metrics, trending, and periodic effectiveness review
Predictive, self-service DMS: automated review scheduling, real-time control metrics, and continuous-improvement feedback across the network
How is change control managed across your site?
Changes tracked informally — no formal review board
Change control SOP exists; review is inconsistent
Formal change control with cross-functional review and regulatory impact assessment
Integrated change management linked to risk register, CAPA, and regulatory intelligence
Predictive change management: automated risk-based routing, live regulatory-impact intelligence, and network-wide effectiveness benchmarking
- ›Obsolete or uncontrolled documents in use at the point of work — no effective version control.
- ›Changes implemented without a documented impact / risk assessment or a regulatory-impact evaluation.
- ›Records not completed contemporaneously; entries missing, backdated, or lacking a second-person review.
- ›Change controls closed without an effectiveness check, or with implementation actions left overdue.
Recent FDA recalls whose reason SPEQ maps to this domain — a SPEQ editorial interpretation of the recall reason, not an official FDA classification.