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Validation:
- Commissioning and Validation of equipment, processes and building support systems (FAT, SAT, Commissioning, IQ, OQ, PQ)
- Systems include CIP, SIP, Compounding, Fermentation, Reactors, Filtration, De-Activation (Kill), Autoclaves, Isolators, Tablet Coaters, Fillers, Labellers and Packaging equipment.
- P&ID walkdown, piping and layout verification, document verification, design document verification (URS, FRS, etc)
- Process testing, instrument and component testing & troubleshooting
- Generation and execution of test plans and protocols (FAT, SAT, IQ, OQ, Validation master plan, commissioning reports, calibration reports)
- Validation of submission documentation and turn-over packages
- Equipment material and manufacturing inspection, including weld inspection and compliance to Ontario’s pressure piping regulation and ASME’s BPE
- Pressure vessel package compliance verification
- Generation of Standard Operating Procedures (SOP’s), templates and record formats
- Training for industry guidelines, validation, commissioning, GMP’s, good documentation practices, SOP’s and Quality Management Systems.
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Quality System Management:
- Development of Quality Management Systems including mapping business processes, writing Quality Manuals & procedures and registration with recognized authorities
- Internal auditing of quality management systems, i.e. ISO 9001, Work Instructions and custom management methodologies
- Development of Pressure Piping Manuals (registration requirement in Ontario) and Pressure Vessel Manuals (in compliance with CSA, ASME and NBBI)
- Non-conformance investigations and analysis, including corrective and preventative measures
- Generation of Standard Operating Procedures (SOP’s), templates and record formats
- Employee training
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Services