Food and Drug Administration (FDA).(1) The findings resulted in a cascade of regulatory requirements and guidelines for more rigorous computer and software validation: An analysis of more than 3,000 medical device recalls between 1992–1998 revelated that in 79% of those cases, software defects were to blame, according to the U.S. In the 1990s, computer validation issues became a sizeable stumbling block for life sciences companies. This article will review GAMP and why its benefits for computer validation still resonate.
Good Automated Manufacturing Practice (GAMP) guidelines are a key resource to help manufacturing minimize that risk. Faced with new competitors, more complex data-centric products, and greater regulatory demands, manufacturers are turning to automation as a way to achieve differentiation and avoid potential pitfalls like failed audits or recalls. While life sciences industry growth in 2020 and beyond appears promising, risk avoidance remains a concern for most companies.