CSV/CSA Services

We provide CSV Services which is current FDA requirement covering all key aspects of Computer System and respective software.
CSV Services includes Framework preparation, Testing Scripts and Execution. After Framework preparation, Below are the activities performed by us in CSV:

  • Validation Master Plan
  • Vendor Assessment
  • URS Preparation
  • FRS Preparation
  • Mapping URS with FRS
  • Design Qualification
  • Configuration Specification
  • Validation Check of Server (IQ/OQ Check)
  • PQ Tests for each PC
  • User Rights Challenge
  • Risk Assessment
  • Traceability Matrix
  • Summary Report
  • Check List Hand Over