Control Systems Validations
Computerized systems used for GxP processes, especially in facilities and equipment in the pharmaceutical and chemical industry environment, must guarantee:
Product traceability
Data integrity
The product quality
Within the framework of life cycle management in accordance with the EU GMP, Annex 11 and US21 CFR Part 11, the GxP relevance of computerized systems must be evaluated.
IDI includes in its catalogue of services the validation of control systems, guaranteeing that the process meets the defined user requirements, regulatory guidelines and established quality standards.