Validation Services

  • Stage 1
    • Designed for customer w/ internal QMS covering all aspects of computer system validation
    • Comprises a set of documents to demonstrate that all functions and features are fit for their intended use (e.g. general user requirement specifications, trace matrix, OQ report)
    • Further technical information is provided upon request
  • Stage 2
    • Tailored support in addition to Stage 1
    • Comprises customer specific documentation incl. customer specific URS, risk assessment, IQ/PQ, project validation master plan & report
    • Additional support for SOP writing and functional testing