Life-Sciences eQMS 16 items
Computer System Validation (CSV/CSA) Checklist (GAMP 5)
Verifies that a GxP computerized system is validated using a risk-based, critical-thinking lifecycle per GAMP 5 and FDA Computer Software Assurance principles. Use for new system validation and periodic review.
GAMP 521 CFR Part 11FDA CSA Draft Guidance21 CFR 820.70(i)
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Planning and Governance
- Is there an approved validation plan defining scope, approach, roles, and deliverables? *
- Is the system categorized (GAMP software category 1/3/4/5) with a rationale? *
- Is the intended use of the system in the process clearly documented? *
Risk Assessment
- Has a risk assessment identified functions with patient safety, product quality, or data integrity impact? *
- Is testing effort scaled to risk (scripted vs. unscripted / ad hoc) per CSA? *
Requirements and Specification
- Are user and functional requirements documented, approved, and testable? *
- Is a requirements traceability matrix maintained linking requirements to tests? *
- Are Part 11 controls (audit trail, e-signature, access) included in requirements where applicable? *
Supplier Assessment
- Was the software supplier assessed/audited and leveraged documentation evaluated? *
- Is configuration and any custom code controlled and documented? *
Testing and Qualification
- Were installation (IQ), operational (OQ), and performance (PQ) qualification activities completed as applicable? *
- Are test results, deviations, and their resolutions documented and reviewed? *
- Is a validation summary report approved before release to production? *
Operational Lifecycle
- Are change control and configuration management applied to the validated system? *
- Are backup, restore, disaster recovery, and periodic review procedures in place? *
- Record the date the system was released for GxP use.
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