Equipment Validation with ITS

At Industrial Technology Systems Ltd (ITS), we take pride in our extensive experience and expertise in providing top-tier equipment, facility, and process validation services, specifically tailored to the unique needs of medical device and pharmaceutical manufacturers.

Our commitment to excellence is underscored by our proficiency in regulatory frameworks, including 21 CFR Part 211, 21 CFR Part 11, 21 CFR Part 820, and adherence to GAMP® guidelines.

Ensuring Compliance and Quality in Life Science

Our team of seasoned engineers possesses an in-depth understanding of the intricate regulatory landscape governing the life sciences sector.

This encompasses the FDA's Electronic Records and Signatures regulation (21 CFR Part 11) and the Quality System Regulation for Medical Device and Invitro Diagnostic Products (21 CFR Part 820).

This proficiency equips us to offer equipment validation services that are not only comprehensive but also meticulously aligned with industry standards.

Strategic Approach in Validation

At ITS, we firmly believe in a risk-based approach to validation. Our process begins with rigorous Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) testing procedures.

This strategic foundation ensures that equipment, facilities, and manufacturing processes not only meet stringent quality benchmarks but also adhere to regulatory requirements.

Success Stories

ITS Designs & Implements a Siemens PCS7 Control System Based on PCS7 Architecture for National Grid

National Grid’s Churchover site currently receives gas from the North only. This gas is compressed and piped off the station for delivery...

A Diverse Portfolio

Our validation experience is as diverse as the industries we serve, encompassing a wide array of equipment and processes. Our capabilities include but are not limited to:

Equipment:

Autoclaves

Automated Device Assembly Lines

Batch Weighing & Dispensing Equipment

Binder Preparation Vessels

Bin Washers

Blenders

Capsule Fillers

Cartooning & 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 Machines

Freeze Dryers

Granulators

Heat Sealers

Incubators

In-Process Checkweighers

Laboratory Instruments

Material Testers

Medtronic Promoters

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

Your Partner in Equipment Validation

ITS is dedicated to ensuring that your equipment, facilities, and processes not only meet but exceed the exacting standards of quality and compliance demanded by the medical device and pharmaceutical industries.

Our validation services are founded on a solid foundation of regulatory knowledge, a risk-based approach, and a commitment to excellence.

With ITS as your partner, you can trust that your operations will consistently operate at the highest levels of performance and integrity, ultimately benefiting your organisation and, most importantly, your patients.

How ITS can help?

Our comprehensive equipment validation services at ITS are tailored to meet the unique needs of medical device and pharmaceutical manufacturers.

With a deep understanding of regulatory requirements, a risk-based approach, and a diverse portfolio of validated equipment and processes, ITS stands as your trusted partner in ensuring compliance and quality in every aspect of your operations.