Computerised Systems Validation (CSV) Audit

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Computerised Systems Validation (CSV) Audit

Computerised Systems Validation (CSV) is a mandatory prerequisite for research and healthcare actors from good practices (GVP, GDP, GMP, GCP): Marketing Authorisation Holders / "Exploitant", Manufacturers, Sponsors, Clinical Sites and their Service Providers.

Sunnikan performs audits, following a risk-based approach, aimed at assessing the validation methodology and adequacy of the validation of your systems (or Service Providers') against the applicable requirements (GAMP5, 21 CFR part 11, Good Practices, etc.).

Our methodology:

  • Definition of your needs to prepare a tailored proposal / contract
  • Audit preparation: kick-off meeting and transmission of documents relevant to the audit
  • Risk-based approach for audit conduct
  • Audit report:
    • Executive summary including an overall assessment
    • Methodology
    • Conduct
    • Audit evidences and findings (with criticality assessment: minor, major, critical)
    • On request: improvement suggestions
  • Preparation and review of the CAPA Plan (as applicable).

Sunnikan draws up audit programs adapted to the needs and obligations of its Clients.

Request for a proposal