Importance of Qualification, Computer System Validation and its Regulatory Compliance in Pharmaceutical Industry

  • Neelu Jain
  • Sanjay Katre
  • Anjaneyulu Vinukonda


In the pharmaceutical sector computer systems are integrated into the regular operations. The process or operation being controlled or monitored by the computer system, the procedural controls, and process related documentation, and the people. Computer systems performing regulated operations may control the quality of a product during its development, testing, manufacturing, and handling processes; manage information business operations; manage data used to prove the safety; efficacy and quality of the product and formulation. Systematic qualification and computer system validation helps to prevent software problems from production environment. A problem in a Pharmaceutical software application which affects the production environment can result in serious adverse consequence and also affect the product quality and business firm like lawsuits, financial penalties which ultimately results the company suffering from economic instabilities, staff downsizing and possibly eventual bankruptcy. The purpose of this industrial based research paper is to present and describe the steps as well as process involve in qualification and computer system validation of instrument/equipment used in pharmaceutical industry with current regulatory guidance

Keywords: Computerised System Validation, Qualification, Regulatory Compliance, Risk Assessment, Good automated manufacturing practice (GAMP)


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How to Cite
Jain, N., S. Katre, and A. Vinukonda. “Importance of Qualification, Computer System Validation and Its Regulatory Compliance in Pharmaceutical Industry”. International Journal of Drug Regulatory Affairs, Vol. 8, no. 3, Sept. 2020, pp. 70-77, doi:10.22270/ijdra.v8i3.411.