Computerised Systems Validation (CSV) Audit

Home Services Computerised Systems Validation (CSV) Audit

Computerised Systems Validation (CSV) Audit

Computerised Systems Validation (CSV) is a mandatory prerequisite for numerous research and healthcare actors: Marketing Authorisation Holders / "Exploitant", Manufacturers, Sponsors (GVP, GDP, GMP, GCP).

Sunnikan performs audits as part of a deep and comprehensive assessment of your CSV approach, or the assessment of systems provided by your Vendors / Subcontractors, following a risk-based approach. This will allow you to identify areas for improvement, and to establish a methodology for ensuring your systems compliance with GxP requirements (GAMP 5, 21 CFR part 11, etc.).

Our methodology:

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

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

Request for a proposal