Abstract
Keywords
computerised system validation, regulatory compliance, system life cycle, risk management, testing, GAMP
Abstract
One of the major concerns of the pharmaceutical industry is the importance of the regulations which have to be fulfilled. These establish various requirements for processes and associated systems without defining the ways to achieve the expected compliance, Such regulatory requirements concern also computerised systems used for manufacturing-, laboratory-, distribution- or clinical study-related activities.
After a short introduction to the pharmaceutical regulatory framework, this article will show the approach for achieving the regulatory compliance used within the industry, based on the recommendations promoted by the GAMP Guide. Thereby, three key-topics will be presented: system life cycle, risk management and system testing.