Document Generation for Regulated Industries

Jonathan Miller Kauffman

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One of the lines in the Agile Manifesto is "Working software over comprehensive documentation." This doesn't mean that no documentation is produced, but instead that only documentation that brings value to the team and the customer should be created. So what do you do when you are working in a regulated industry and you need to produce extensive documentation to prove that the system works correctly? Jonathan Kauffman recently worked with a company that produces FDA Class II medical devices and wanted to reduce the overhead of creating the documentation required by regulatory bodies. Their test team was spending a large amount of time each sprint on producing these documents, which took time away from verifying the system. Come learn how Jonathan and the team solved this problem by automating the generation of one type of document. He'll describe the problem of document generation, how they approached tackling the problem, and future work that can be done in this area.

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