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GAMP 5 Quality Risk Management Approach

Focusing your skilled resources on the risks are highest within the life science industry is essential, and as this article (originally published in Pharmaceutical Engineering) explains, organisations also need to possess the correct risk management methods to facilitate identification and mitigation. As with any risk management method, software presents a few unique aspects that can be leveraged: One aspect of risk that can be leveraged with respect to computerized systems is the general trend that increased complexity of software implies higher risk for failure due to factors like buggy code, incorrect configuration, or improper implementation. Another unique factor for software is based on ubiquity; for some types of software (e.g., operation systems and database managers), there are so many copies on the market that it is a near-certainty that new faults will not compromise the application running on them. GAMP 5 provides guidance in the application of risk management principles for both internally developed and purchased software solutions. As the article explains, through performing an initial risk assessment to determine system impact, identifying key functions with impacts, performing a functional risk assessement, implementing and verifying appropriate controls, and reviewing risks while monitoring those controls, organisations can readily develop a risk management approach in line with best practices.

About Matthew Kabik

Matthew Kabik is the former Editor of Computer Aid's Accelerating IT Success. He worked at Computer Aid, Inc. from 2008 to 2014 in the Harrisburg offices, where he was a copywriter, swordsman, social media consultant, and trainer before moving into editorial.

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