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V-Model system development lifecycle methodology used for project management and software

CSV Consulting


What Pharmaceutical Firms Look For

  • Complete Validation solutions for Safety systems implementation, Signal Management tools and changes to the system including upgrades


How We Can Help

  • Generate a CSV validation plan detailing the scope of work and intent

  • Preparing technical documents like URS, FRS, Traceability Matrix, IQ/OQ protocol and summary report etc.

  • Investigating deviations and executing CAPAs

  • Assisting in the development of training material for qualification activities

  • Use different validation methodologies (V-Model, Agile, Waterfall)

  • Risk assessment and management

  • Documentation and record management

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