Process Validation
Industrial Technology Systems Ltd (ITS) has extensive experience in the provision of equipment, facility and process validation services to medical device and pharmaceutical manufacturers.
ITS’ expertise includes 21 CFR Part 211, 21 CFR Part 11, the FDA’s regulation for Electronic Records and Signatures, and 21 CFR Part 820, the Quality System Regulation for Medical Device and Invitro Diagnostic Products. With a quality management system developed around GAMP®, ITS’ engineers are also experts in working to GAMP® guidelines.
Using a risk-based approach with rigorous IQ, OQ and PQ testing procedures, ITS' validation team is dedicated to demonstrating that equipment, facilities and manufacturing processes meet both quality and regulatory requirements.
ITS' validation experience varies from equipment, machinery and processes through to entire plants. This experience includes but is not limited to the following:
| • Autoclaves | • Incubators |
| • Automated Device Assembly Lines | • In-Process Checkweighers |
| • Batch Weighing & Dispensing Equipment | • Laboratory Instruments |
| • Binder Preparation Vessels | • Material Testers |
| • Autoclaves | • Metronic Prometers |
| • Automated Device Assembly Lines | • Microbiology Incubators |
| • Batch Weighing & Dispensing Equipment | • Micronisers |
| • Binder Preparation Vessels | • Microwave Dryers |
| • Bin Washers | • Mixers |
| • Blenders | • Moisture Balances |
| • Capsule Fillers | • Moulding Machines |
| • Cartoning & Packaging Equipment | • Particle Counters |
| • Chromatography Units | • Particle Detection Systems |
| • Coaters | • Particle Size Analysers |
| • Co-ordinate Measuring Machines | • Printers |
| • Dispensary Systems | • Printing Labelling Equipment |
| • Dry Granulation Rigs | • Purified Water Systems |
| • Drying Ovens | • Robot Arms |
| • Effluent Treatment System | • Sterilisers |
| • Extruders | • Syringe Crack Detectors |
| • Environmental Monitoring Systems | • Tablet Checkweighers |
| • Form-Fill-Seal Machine | • Tablet Presses |
| • Freeze Dryers | • Tensile Testers |
| • Granulators | • Tray Dryers |
| • Heat Sealers | • Vial / Syringe Filling Equipment |
ISPE owns the GAMP® trademark http://www.ispe.org/
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