SOUP: FDA’s Recipe for Open Source Software 

Q: Is it acceptable by FDA to use open source software for low critical applications? These applications do not have a direct impact on patient safety but are used to support GxP activities. An example would be a software testing tool.…

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Regulated Software and Systems: What FDA Expects to See

For the regulated software and systems you use in your activities, consult this list — prepared by former FDA investigators at EduQuest (including EduQuest President Martin Browning, the co-author of Part 11) who have done thousands of computer system audits worldwide —…

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