Project Validation
With over 16 years experience in the validation arena, Industrial Technology Systems Ltd (ITS) has gained significant experience in working with pharmaceutical, medical device and food and beverage companies in ensuring regulatory compliance for both new and legacy systems.
ITS’ commitment to the rules governing regulated industries is demonstrated through our involvement with ISPE, the International Society for Pharmaceutical Engineers, and our active participation in several ISPE Special Interest Groups (SIGs). In recent years ITS employees have been part of the SIGs that have produced or updated the following guides: Validation of Process Control Systems, Testing of Critical Systems, and Electronic Data Archiving. These Special Interest Groups consist of professionals with extensive experience in the pharmaceutical industry and our involvement enables us to share our knowledge and industry best practices with customers.
ITS’ Project Validation Services offer end users a flexible approach to project execution. 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. This may include, but not be limited to:
- Validation Plans or Master Plans
- Design Qualification
- Pre-Delivery Testing
- IQ, OQ and PQ
- SOP Writing
- Regulatory Compliance Training
- Validation Reports
The standards and quality management system that govern all aspects of ITS’ work are modelled on the principles and practices of GAMP® guidelines, taking full account of all associated regulatory requirements. As a result, ITS is well positioned to assist pharmaceutical and medical device industry manufacturers, and their suppliers, in ensuring that new projects, existing systems and entire processes are conceived, specified, designed, built, installed, used and maintained in a compliant fashion.
ISPE owns the GAMP® trademark http://www.ispe.org/
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