Pre-Delivery Testing
Industrial Technology Systems Ltd (ITS) has a team of engineers responsible for providing a range of pre-delivery validation services. Applying their detailed knowledge of cGMP, regulatory requirements and industry best practices, ITS' validation engineers can offer independent examinations, reviews and services to verify that the following stages in the lifecycle are compliant with industry and user requirements:
- Supplier Assessments
- Design Review
- Software Development
- Supplier Testing
- Development Testing
- Coding Standards
We also offer independent advice, and a comprehensive array of Regulatory Compliance Training Courses to bring suppliers up to speed with FDA and MHRA regulations, including 21 CFR Part 11, GAMP® guidelines, and risk-based validation.
With ITS’ pre-delivery testing and independent reviews, we remove the risks encountered in using new suppliers.
ISPE owns the GAMP® trademark http://www.ispe.org/
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