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How do we balance "Working Software" with the need for "Comprehensive Documentation" in regulated industries?


The Agile Manifesto prioritizes working software over documentation, but in my medical device company, we face strict compliance audits. How do teams manage this without reverting to Waterfall? Is there a middle ground where we can remain Agile while still producing the heavy documentation required by law, or is Agile simply a bad fit for highly regulated sectors?


   2024-02-14 in Agile and Scrum by Thomas Miller | 12473 Views


All answers to this question.


The phrase "over" is the most misunderstood part of the Manifesto; it doesn't mean "instead of." In regulated environments, you should treat documentation as a part of your "Definition of Done." Instead of a massive document at the end, create "living documentation" that evolves with each sprint. Use automated tools to generate reports from your code and tests. This way, the documentation is a byproduct of the development process rather than a separate, grueling phase. It keeps the team focused on the software while ensuring the auditors get exactly what they need for compliance

   Answered 2024-02-16 by Nancy Roberts


Have you looked into the "Lean Documentation" movement? It suggests that anything that doesn't add value to the end user or fulfill a legal requirement is waste. What specific documents are causing your team the most delay?

   Answered 2024-02-20 by Mark Stevens

  • Mark, the biggest bottleneck is the "Design History File." We’ve started using "Documentation Sprints" every quarter, but it feels very anti-Agile. I’m curious if anyone has successfully integrated these into a standard two-week cadence without slowing down the velocity of the developers too much.

       Commented 2024-02-22 by Steven Wright


We use a "Doc-as-Code" approach where documentation lives in the same repository as the code. This ensures they stay in sync and follow the same peer-review process.

   Answered 2024-02-25 by Lisa Adams

  • I agree with Lisa. When the documentation is treated with the same level of importance as the source code, the "working software" value actually becomes stronger because the maintenance becomes easier.

       Commented 2024-02-27 by Thomas Miller



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