Computerized system validation provides documented proof that the system (e.g. Hardware, software, peripherals and network) will repeatedly and reliably do what it is designed to do, is “fit-for-purpose”, and complies with the applicable rules and regulations.
Validation of computerized systems according to GxP Guidelines (CSV) has been a basic requirement in the healthcare industry for many years.
Computer system validation is definitely not a “one size fits all” procedure; the approach that an individual company may take to a specific validation depends on the rules, guidance, best practices, and characteristics of the system being validated.
TPS Company offer consultation services to support the implementation of CSV and ERES (CFR Part 11) based on the Guideline on Management of Computerized Systems set forth by the Ministry of Health, Food and Drug Administration, and Good Automated Manufacturing Practice (GAMP), including latest debates and trends.
Our CSV experts help in analysis, design, execute and manage validation requirements as per the FDA, EU and various global compliance requirements.