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Computer System Validation (CSV/CSA) Checklist (GAMP 5)

Этот чек-лист на английском языке.

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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