GxP in Computer System Validation

GxP in Computer System Validation.

GxP (Good X Practice, where according to FDA compliance; X can mean Clinical, Laboratory, Manufacturing, Pharmaceutical, etc., and used according to the situation in which they occur) in Computer System Validation occupies a position of primacy in the field of technology because of various reasons. The important ones among these are the heavy use of software in a wide range of medical activities, and the changing nature of computer technology, which has a deep impact on pharmaceutical devices and related products. Companies in these businesses need to ensure that the best practices in software are implemented mainly to keep abreast of the developments.
GxP in Computer System Validation has developed at a rapid pace of late because of the trend to integrate electronic records into manufacturing practices. While this has led to huge improvements as far as the speed of processing records is concerned; it has also brought in its wake a few inevitable challenges. .

Critical aspects of GxP in Computer System Validation

GxP in Computer System Validation consists of at least three extremely important aspects. One, GxP in Computer System Validation in the life sciences industry is not a monolithic and inflexible set of instructions. It consists of various rules and applications that need to be applied by companies according to their need and requirements. In other words, a generalized, “one size fits all” approach does not work for GxP in Computer System Validation.

Secondly, these validation requirements need to be implemented at various stages of the Software Development Lifecycle (SDLC). This means that medical device, pharmaceutical, life sciences and other related industries need to comply with GxP validation at every stage of development of the product.

Also, it goes without saying that compliance is mandatory. Noncompliance invites penalties, because GxP requirements set out by the FDA have the effect of the law.

References:

http://www.stsv.com/pdfs/STS_CSV_article.pdf

http://www.21cfrpart11.com/files/library/miscellaneous/pics_guidance_jan01_draft.pdf

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