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QVC offers a wide range of validation services to help you meet your regulatory and compliance needs:
- Commissioning and Validation of process equipment and building support systems (FAT, SAT, Commissioning, IQ, OQ, PQ)
- P&ID walkdown, piping and equipment layout verification
- Document qualification, design document verification (URS, FRS, etc)
- Software testing, process testing, instrument and component testing & troubleshooting
- Generation of test plans and test protocols (FAT, SAT, IQ, OQ, Validation master plan, commissioning reports, calibration reports)
- Validation of qualification documentation and turn-over packages
- Construction material and manufacturing inspection, including weld inspection, compliance to Ontario’s pressure piping regulation (TSSA & CSA) and ASME BPE
- Pressure vessel package compliance verification
- Pressure vessel inspection, Sprayball testing
- Cleaning Validation
- Process testing including SIP (Sterilization in place), CIP (Clean in Place) & KLA mixing tests
- Generation of Standard Operating Procedures (SOP’s), templates and record formats
- Training for industry guidelines, validation, commissioning, GMP’s, good documentation practices, BPE, SOP’s, ISO 9001, etc
The following is an overview of some of the equipment commonly tested:
- Bioreactors & Fermenters
- Waste Inactivation (Kill) systems
- CIP systems
- Filtration units
- Clean steam generators, WFI Stills
- WFI, USP or Purified Water systems
- Chromatography units
- Media and Buffer Prep and Hold systems
- Mixing, Blending, Filling and Packaging equipment
- Custom designed equipment
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