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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 GAMPฎ, ITS’ engineers are also experts in working to GAMPฎ 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:

ISPE owns the GAMPฎ trademark http://www.ispe.org/