Our services include Risk Assessments, Validation Plans, Business/User & Functional Requirements, IQ/OQ/PQ Protocol Analysis and Output Summary Documentation. All items are integrated through a Traceability Matrix established within your existing CSV model. Lean on us to draft requirements, create test cases, and perform all validation and documentation work. Finally, we will integrate the requirements and test cases with businesses proprietary SOP's.

We follow internationally accepted GAMP guidelines for Validation of Computerized Systems & Software applying Risk Based Approach with Life Cycle Management

  • ♦ LAB System Validation
  • ♦ IT Infrastructure Qualification
  • ♦ BMS
  • ♦ PLC & SCADA Validation
  • ♦ US FDA 21 CFR Part – 11 Compliance
  • ♦ Maintaining Control In Operation (MCO) Services