Computer System Validation is not mere testing
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Computer system validation for life science software is critical to ensure patient safety and avoid drug recalls, as malfunctions can cause serious harm or death. Regulatory agencies strictly govern the pharmaceutical industry and require validation throughout the software development lifecycle to comply with quality standards. Following guidance from regulations like Part 11, GAMP, PIC/S and ISPE can help organizations properly validate their systems and address issues that have previously led to over 10% of drug recalls due to software defects.
Computer System Validation is not mere testing
- 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