Project Management & Engineering Services > Process Validation

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

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



Contact our team today

For further information, please contact
our team on +44 (0)1642 222232 or
email enquiries@its-ltd.co.uk