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The Evolution of Validation Best Practices

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Data Sheet 1 Data Sheet Validation Best Practices Life science companies are struggling with the burden of software validation. For companies regulated by the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA), validation of their electronic systems is required. As practiced by many regulated companies today, validation is also the single most expensive and time-consuming aspect of automating or upgrading their quality management and compliance systems. It is time to dispel old ways of thinking about software validation and what validation best practices look like. Validation Requirements Have Evolved, So Should Validation Processes The FDA's position has been that the agency never intended for organizations to go to the extreme lengths they have been to validate software since 21 CFR Part 11 was released in 1997. The FDA provided guidance in 2002 to help clarify that companies don't have to validate a quality management system (QMS) the same way they validate a medical device. This message has been getting lost, so the FDA has been trying to refocus efforts on risk-based validation. While the FDA requires validation today, it does not specify how to validate. Rather, the federal agency wants evidence that companies have documented how they intend to validate and then prove that they've done it the way they said they were going to. Regarding validation activities, the FDA advises that the level of validation should be "commensurate with the risk posed" and recommends that companies pursue the "least burdensome approach." For companies wanting to take advantage of today's technology, utilizing risk assessments is an effective alternative to the traditional validation paths. The FDA has encouraged medical device developers to adopt new technologies based on risk assessment, though the agency hasn't prescribed a formula for calculating risk. To that end, MasterControl takes a risk-based approach to software validation. MasterControl clients are able to leverage the full validation performed internally for every release to help mitigate their software implementation risks. Risk- based validation is a way to formally assess software risk based on several

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