Coronavirus Update: We are open for business as usual.      We are hiring now: Check "Careers" link.

Regulatory Compliance Services

Regulatory Compliance Services

GMP, GAMP® & Validation Training

Industrial Technology Systems Ltd's (ITS) GMP, GAMP® & Validation Training Courses are designed to equip learners with the skills and knowledge to achieve and maintain compliance in pharmaceutical and medical device manufacturing environments. By involving ITS’ training team we can ensure that your employee’s contribution to productive activity is maximised in a way that is consistent with best practice.

Auditing Services

ITS’ Regulatory Compliance Services team offers a range of auditing services to help companies maintain compliance and improve their quality management system performance, including self-inspection and internal audits, root cause and corrective action services, gap analysis audits and supplier audits.

Validation & Training Package

Companies looking to achieve FDA compliance can take advantage of Industrial Technology Systems Ltd’s Validation & Training Package – a tailor-made programme designed to meet corporate regulatory needs.  Following a site visit and audit to identify validation and training requirements, ITS will put together a bespoke validation and training package that meets specific company needs and responds to each organisation‘s individual requirements.

Validation Resource Service

ITS recognises that peaks in validation engineering demand can leave companies vulnerable, when validation expertise is unavailable. To enable companies to cope with validation manpower demands, ITS offers a validation resource service. Whatever your requirements, whether you need an engineer to complete short term validation tasks or a long term validation project, ITS can provide the level of expertise, to meet your requirements.

Project Validation

With over 25 years experience in the validation arena, ITS has significant experience in working with pharmaceutical, medical device and food and beverage companies. ITS’ Project Validation Services offer end users a flexible approach to project execution and management. ITS can take full responsibility for the project, from the initial Validation Master Plan through to final report, or we can assist in any stages that the customer requires.

Computer System Validation

The value of a risk-based approach to computer, software and automated system validation cannot be underestimated. Whether it’s the need for computer system validation as part of a vital process automation project, the generation of a robust suite of operating procedures, assistance with the latest 21 CFR Part 11 requirements or an audit of your existing systems and validation status, there is an ITS service to benefit your organisation.

Process Validation

Using a risk-based approach with rigorous testing procedures, ITS is dedicated to demonstrating that equipment, facilities and manufacturing processes meet both quality and regulatory requirements. ITS’ expertise includes 21 CFR Part 211, 21 CFR Part 11, and 21 CFR Part 820. With a quality management system developed around GAMP®, ITS’ engineers are also experts in working to GAMP® guidelines.

Data Integrity Services

ITS offers a range of data integrity services including data integrity consultancy, data integrity audits and data integrity services. Our experience covers a vast range of processes and equipment in both manufacturing, packaging and laboratory facilities.

Technical Training

With over 28 years’ experience in the design and implementation of industrial automation, control and management information systems, ITS’ engineers share their engineering skills, expertise and experiences through a range of Technical Training Courses. These courses are designed for engineers and technicians with limited programming skills and experience.

Fire Safety Training

ITS offers online fire safety training suitable for all employees, to assist them in identifying and reducing the risk that fire presents in the workplace. The VideoTile-based learning uses online video methods allowing for extremely high quality and fast video.

Training Services

ITS provides a range of Training Services including Training Needs Analysis, Learning Transfer in the Workplace, NVQ Services, Curriculum Advice and E-Learning Solutions. As an external company, ITS’ training team is in a good position to see beyond the immediate issues and can give a better insight into what is needed to achieve the maximum benefit. Our experience in many industries makes us aware of the strengths and weaknesses of individuals, the capabilities of departments and the skills and aptitudes needed for business growth.