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Equipment 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. ITS’ team also has a good understanding of the data integrity and GxP guidelines governing the life sciences sectors.

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
  • Automated Device Assembly Lines
  • Batch Weighing & Dispensing Equipment
  • Binder Preparation Vessels
  • Bin Washers
  • Blenders
  • Capsule Fillers
  • Cartoning & Packaging Equipment
  • Chromatography Units
  • Coaters
  • Co-ordinate Measuring Machines
  • Dispensary Systems
  • Dry Granulation Rigs
  • Drying Ovens
  • Effluent Treatment System
  • Extruders
  • Environmental Monitoring Systems
  • Form-Fill-Seal Machine
  • Freeze Dryers
  • Granulators
  • Heat Sealers
  • Incubators 
  • In-Process Checkweighers
  • Laboratory Instruments
  • Material Testers
  • Metronic Prometers
  • Microbiology Incubators
  • Micronisers
  • Microwave Dryers
  • Mixers
  • Moisture Balances
  • Moulding Machines
  • Particle Counters
  • Particle Detection Systems
  • Particle Size Analysers
  • Printers
  • Printing Labelling Equipment
  • Purified Water Systems 
  • Robot Arms
  • Sterilisers
  • Syringe Crack Detectors
  • Tablet Checkweighers
  • Tablet Presses
  • Tensile Testers
  • Tray Dryers
  • Vial / Syringe Filling Equipment

ISPE owns the GAMP® trademark http://www.ispe.org/