Computer system validation in the perspective of the pharmaceutical industry

Abstract

Computer Systems Validation (CSV) is a process used to ensure (and document) that a computer based systems will produce information or data that meet a set of defined requirements. If a system meets these requirements, it can be assumed that it is consistently performing in the way it was intended. Quality is an imperative for customers whenever they consider a product or service. It is also important as it relates to life-saving products such as pharmaceuticals. In this regard, the Food and Drug Administration introduced good manufacturing practice (GMP) to maintain and improve the quality of pharmaceutical products. GMP ensures that products are consistently produced and controlled according to the quality standards appropriate to the intended use and as required by the marketing authorization. One of the major GMP requirements is that all of the critical manufacturing equipment, utilities, and facilities in the pharmaceutical industries must be properly qualified and validated prior to production. Currently, this practice forms the core of the regulations that are strictly followed by pharmaceutical companies worldwide. A validation assessment program is a necessity in the pharma industry to ensure adherence to pharmaceutical cGMP guidelines, and to help companies maintain consistent quality. The same principles are applied in computer system validation to a computer system or an information technology system. It’s essential to maintain quality standards in pharma since non-conformance can have far-reaching consequences. Computer system validation checks the effectiveness and the efficiency with which the system is meeting the purpose for which it was designed. This study aims to identify needs of computer system validation of instrument/equipment practiced in the perspective of pharmaceutical industry.
 Keywords: Computer system validation, Validation, Qualification, GAMP