Auditing

The service includes but is not limited to:


  • Drug Safety / Pharmacovigilance audits
  • Readiness check for GxP regulated computerized systems in view of a forthcoming health authority inspection
  • 21 CFR Part 11 compliance analysis
  • Customer audits of data management service provider
  • Customer audit of software provider
  • Customer audit of PV service provider
  • Customer audit of GMP facilities or processes

 

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