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Computer System Validation is not mere testing

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Computer System Validation is one of the critical activities that assures Product Quality and Patients Safety to meet the ultimate goal of the regulatory agencies across the globe. Most traditional SDLC/ testing approaches is not suitable to deploy applications to regulated companies under GxP environment. One should have high technical skills and very good understanding about GxP, Predicate rules, 21 CFR Part-11, Annex-11, GAMP, ISPE and PIC/S to define a process that delivers reliable and quality software to regulated companies. Well-designed Computer System Validation process will assure Product Quality, Patient Safety, Data Security and Data Integrity and eliminates risk of 483 and warning letters.

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Computer System Validation is not mere testing

  1. 1. Computer SystemValidation is not mere testing? A malfunction in a life science software application may cause serious adverse events, including irreversible damage to human life. GxP is highly regulated environment for the drug design, development, manufacturing and sales from regulatory agencies. Implementing Quality System Requirements from Regulatory agencies are mandatory by law. Specific controls and recommendati ons from Part- 11, GAMP, PIC/S and ISPE must consider throughout the SDLC More than 10% of the drug recalls are due to software defects, 80% of them due to lack of good software engineering practices Uncontrolled changes and incomplete validation to the software under production will leads to compromise in product quality and Patient safety Ananda Rao. C
  • PREMADAMBAL

    Feb. 21, 2017

Computer System Validation is one of the critical activities that assures Product Quality and Patients Safety to meet the ultimate goal of the regulatory agencies across the globe. Most traditional SDLC/ testing approaches is not suitable to deploy applications to regulated companies under GxP environment. One should have high technical skills and very good understanding about GxP, Predicate rules, 21 CFR Part-11, Annex-11, GAMP, ISPE and PIC/S to define a process that delivers reliable and quality software to regulated companies. Well-designed Computer System Validation process will assure Product Quality, Patient Safety, Data Security and Data Integrity and eliminates risk of 483 and warning letters.

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