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Omprakash G. Bhusnure*, Kendre S.P., Kaudewar D.R., Bankar I. N,
Sachin B. Gholve and Giram P. S.


A Computer System Validation is a set of activities that FDA Regulated companies must conduct for each of their GxP sensitive computer systems. The objective of these activities is to document evidence that each computer system will fulfill its intended purpose in a GxP production, laboratory, or research operation. The intention is to avoid software problems that could have serious impact. Dynamic testing of the software is an important part of the Computer System Validation. But Computer System Validation is more than just this type of testing. Computer System Validation requires a comprehensive set of equally important static testing activities that need to be conducted throughout the SDLC (Software Development Life Cycle). This includes a variety of analyses, audits, walkthroughs, reviews, and traceability exercises. Documentation must be accumulated that demonstrates that these activities have been performed effectively. Today, the term Computer System Validation refers specifically to the technical discipline used in the Life Sciences sector to help ensure that software systems meet their intended requirements. Through its regulations/guidance on Computer System Validation, the FDA has shaped IT testing and analysis processes to match the needs and requirements of the industries it governs. As a result, Computer System Validation has become an integral part of doing business in FDA regulated environments. It should be noted, however, that significant progress has been made in achieving consistency and harmonization between FDA regulations/guidance on Computer System Validation and relevant international IT standards and best practices. It is likely that the future will see convergence of Computer System Validation terminology and techniques as a common technical discipline across other industry sectors as well.

Keywords: Computer System Validation, SDLC, FDA regulations, Data Management.

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