Computerized system validation (CSV) is the documented process of assuring that a computerized system does exactly what it is designed to do in a consistent and reproducible manner.
GAMP Services simple and appropriate manner of establishing the required documented evidence for the proof of the same, holds a great value and assures that a computerized system will consistently perform as intended in its operational environment. The validation process begins with the system proposal/requirements definition and continues until system retirement and retention of the e-records based on regulatory rules.
CSV is of particular importance to industries requiring high-integrity systems that maintain compliant with current regulations designed by different national and international regulatory authorities like USFDA, EMEA, EU GMP, ANVISA Brazil, Health Canada, WHO and ICH Guidelines etc. under all circumstances.
We Provide Services for:
GAMP Services has developed a comprehensive solution to support Life Sciences companies with comprehensive testing of regulatory requirements. Our Validation Package provides assistance with core regulatory requirements.
Validation Process provides some pre-configured content rich set of templates, ready for customization to meet both domestic and international regulations. Our documentation templates include: