Author(s): Dhatchanamoorthi N, Raju Kamaraj

Email(s): dhatchandsna16@gmail.com

DOI: 10.5958/0974-360X.2020.00975.0   

Address: Dhatchanamoorthi N, Raju Kamaraj
Department of Pharmaceutical Regulatory Affairs, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur-603203, Kanchipuram, Tamil Nadu, India.
*Corresponding Author

Published In:   Volume - 13,      Issue - 11,     Year - 2020


ABSTRACT:
In pharmaceutical industry, the regulatory compliance of computer system is increasing their importance. The regulation required to maintain a record for its safety, strength, efficacy, and quality for the substance. It establishing documented evidence to provide a high degree of assurance in a way of software or hardware which gives a fulfillment in line with the regulatory guidelines for certain industries mainly the 21 CFR part 820 and 21 CFR part 210 and 211 is applied to pharmaceutical product and is also applied to the medical device. The given life cycle model included the stage of 1. Planning, 2. Specification, 3. Programing, 4. Commissioning, 5. Testing, 6. Documentation, 7. Operating, 8. Monitoring and 10. Modifying. The V- Module supports structured testing it is very essential for successful validation. In this computer system validation content attach with the user requirement specification knowledge and a way to avoid a failure in computer system validation planning and many sources about this CSV are clearly discussed in this validation document.


Cite this article:
Dhatchanamoorthi N, Raju Kamaraj. An Overview on Challenges and Importance of Computer system Validation in Pharmaceutical Industry. Research J. Pharm. and Tech. 2020; 13(11):5591-5594. doi: 10.5958/0974-360X.2020.00975.0


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