Computerized System Validation


A large variety of laboratory equipment, instruments, and computerized analytical systems are used in pharmaceutical industries to acquire data. We provide 360? support in the following equipment validation:

  • Project Management (Project Guidelines and Positioning, planning)
  • Development Documentation (URS, FS, Evaluation/Categorization of criticality)
  • Validation Strategy and Policies (Validation Procedures, Master Validation Plan, Validation Plan, Risk Analysis based on GxP regulatory requirements, Consideration of equipment categories (specificity, complexity and specifications described in USP 1058 AIQ Pharmacopoeia)
  • Test plans, execution, verification of executed tests (TMX, IQ, OQ, PQ)
  • Validation conclusion (Execution Report, final Validation Report)
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