Computer system validation and CSV infrastructure

Computer system validation and CSV infrastructure

“Whether you install a new equipment or a piece of instrument in an existing equipment system, we provide assessment and computer system validation services through the following steps:”
  • URS (User requirement specification)
  • IRS (Initial risk assessment)
  • VP (Validation protocol)
  • Identification of computer system for its applicable category for assessing the FRS and performing FRS (Functional requirement specification)
  • FRA (functional risk assessment)
  • Configuration system followed by a retrospective IQ or through a new IQ, OQ and PQ
  • RTM (requirement traceability matrix)
  • VSR (validation summary report)
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