Commissioning, Qualification and Validation (CQV)

Our team of cross-functional consultants offers Commissioning & Qualification expertise in a variety of cGMP and cGLP equipment and facility systems, which are listed below. In addition, we are experienced with implementing strategic and risk-based C&Q approaches such as ASTM E2500 and ICQ, which allow faster execution and reduced execution costs.

We offer Commissioning and Qualification, Cleaning Validation, Process Validation services in a variety of equipment and facility systems, such as the ones listed below:

  • Equipment CQV (Process Equipment, Packaging Equipment, Clean Utilities, CIP Systems, Washing & Sterilization, Fill Finish)
  • Facility Systems CQV (Cleanrooms, Critical Utilities and Process Gases, HVAC)
  • Automation Systems CQV (BAS, PLCs, DCS systems)
  • Lab Equipment CQV

We also offer the following additional services:

  • Thermal Validation.
  • Computer systems validation of IT systems to meet 21 CFR Part 11 Compliance.
  • Compliance audits, gap analysis, cGMP remediation, audit support, risk assessments
  • VMPs, Validation Project Plans, Validation Strategies and Approaches.