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