What Kinds of Software Must Be Validated?
To answer this question, it’s important to understand why the software needs to be validated. There are precise definitions of validation and broadly accepted activities that lead to the conclusion that software is validated. But, when all is said and done, validation activities must confirm that the software does what the user wants it to, and that patients, users, bystanders, the environment, and the medical device company are reasonably well protected from any potential failure of the software. So, what software needs to be validated other than that which is part of a medical device? It is often tempting to simply conclude that all software should be validated. What Is Required? As noted earlier, 21 CFR 820.70(i) requires validation of software that automates all or part of any process that is part of the quality system. That software includes the following: • Software used as part of the manufacturing process (including software embedded in machine tools, statistical process contro
