I worked for a number of years working on a "validated" commercial-off-the-shelf system for big pharma; one of the first of its kind. Typically, all software supporting "GxP" (GCP = Good Clinical Practice, GMP = Good Manufacturing Practice, et.) processes must go through this process of validation (to degrees, determined by risk).<p>The term "validated" here typically refers to the GAMP5 "V model" of building software releases where there is a direct correlation between the various stages of build and release to some documentation (requirement, specification, design, install procedure, and test procedure).<p>By far, this was probably the highest quality software I've built in my career. Given the scope of what we were delivering for large enterprise pharma customers, our defect rate was surprisingly low. This is a system that's used every day in tens of thousands of clinical trial sites around the world.<p>An interesting aspect of change management in GxP validated software is that <i>the process starts with identifying the documents that are going to be affected</i>. In other words, when we start a release, we would work with the sponsor (like a Merck or Pfizer) and the teams would make a "change request" document that inventoried which documentation would be affected. For example: which original requirements are to be updated, which specifications are changed, which installation procedures need to be updated, which test scripts are affected, etc.<p>This process is incredibly onerous and time consuming, but also ensures that not only is the output very high quality and low defect, but also well documented. I often thought that this is probably one area that is ripe for disruption, especially with LLMs. (It is also one of the reasons why it is rare to see startups building software that supports GxP processes).<p>(For most teams, I think that Basecamp's "Shape Up" [0] is probably the most balanced change management process that yields acceptable speed, minimal wasted effort, while still allowing space for high quality software to be built.)<p>When I think about this period of my career, I often think about an article <i>They Write the Right Stuff</i> [1] on how NASA's tolerances are perhaps at the extreme end of human perfection in software. A great read!<p>[0] <a href="https://basecamp.com/shapeup" rel="nofollow">https://basecamp.com/shapeup</a><p>[1] <a href="https://www.fastcompany.com/28121/they-write-right-stuff" rel="nofollow">https://www.fastcompany.com/28121/they-write-right-stuff</a>