https://stackoverflow.com/questions/18740489
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RussianI believe TFS can be validated for FDA Compliance for Static Code Analysis and other requirements depending on your QSIA Intended Use. As mentioned in OP's comment the key is validating how you are using a tool, not whether it is validated "out of the box". I believe you must validate that you have configured and use static code analysis in a way that is compliant. Just having a tool doesn't make its output automatically compliant (unless there is a "FDA-compliant" setting that cannot be disabled :-)).
Food and Drug Administration (FDA) Compliance with Visual Studio 2010 (MSDN whitepaper by Northwest Cadence, June 2011) has an extensive walkthrough of TFS features mapped to FDA compliance and FDA document "General Principles of Software Validation". Static code analysis is specifically mentioned. Here is the relevant excerpt:
Static Code Analysis The static code analysis in Visual Studio 2010 has several hundred rules that check code for potential code errors in several areas, which include design, naming, reliability and security. These rules can be combined into rule sets that allow only a specific subset of the rules to be run, highlighting potential problems. These range from the “Minimum Recommended Rules," which focus on the most critical problems in your code, including potential security holes, application crashes, and other important logic and design errors, to the “All Rules” set. which contains every available rule. It’s very easy to configure a custom rule set to focus your code analysis specifically toward your needs.
There may be other references that are (or will be) relevant. Try following search keywords: TFS FDA (or better yet use +TFS +FDA to force major search engines to have both terms). +VS +FDA might return other relevant results especially if you are looking specifically for code analysis rather than overall compliance for eSignature and other Part 11 requirements.
Please vote if you found this helpful. Thanks! -Zephan
