Commissioning, Qualification and Validation Services

Our team of cross-functional staff offers Commissioning & Qualification expertise for a variety of cGMP and cGLP process, equipment and facility systems. We are experienced with implementing strategic and risk-based C&Q approaches such ASTM E2500 and ICQ, allowing for faster execution and reduced costs. Experience with CQV project execution with the use of paperless validation software

Validation Master Plan & Validation Project Plan Development

Commissioning & Qualification

  • Facility C&Q
    • Cleanrooms
    • Critical Utilities
    • HVAC
  • Process C&Q
  • Equipment C&Q
    • Process and packaging equipment, including serialization
    • Clean Utilities, CIP, SIP, Lyophilization, Fill/Finish
  • Lab Equipment C&Q, including computerized lab equipment
  • Automation Validation (Process Controls – PLCs / DCS, BAS, SCADA, MES)
  • Laboratory Systems and Applications: LIMS, Empower, ChemStation, OpenLab CDS, Analytical Systems HPLC, GC-MS, UV-vis, FTIR etc.

Validation Services

  • Cleaning Validation
  • Process Validation
  • Thermal & Sterilization Validation, including Temperature Mapping
  • Computer System Validation
  • Experience with CQV project execution with the use of paperless validation software
  • Serialization system validation
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Let's talk.

For any inquiries of our services or previous work, please contact us.