The book is very approachable and free in digital form. I strongly recommend anyone that has an interest in this space skim it and decide on your own. Even if

The book is very approachable and free in digital form. I strongly recommend anyone that has an interest in this space skim it and decide on your own. Even if you end up disagreeing with or finding faults, it adds perspective and perhaps there are a few ideas that can be applied. On point 3, that really depends on how rigorous the testing process is. One of my favorite essays on the topic of software engineering is "They Write the Right Stuff" [0] which describes how NASA writes their software and why/how they achieve incredibly low defect rates. NOVA has two documentaries: "Pluto and Beyond" and "Chasing Pluto" that puts this into perspective. The New Horizons team was formed in 2000, the satellite launched in 2006, and 15 years after the kickoff reached Pluto. In the documentary, some of the folks had sent off their kids to college by the time New Horizons reached its primary mission objective; truly a life's work. The stakes aren't that high in life sciences and most programs, but in processes that involve GxP, there's generally a risk of injury so it is still higher than say something like Notion or Reddit. True: even with the most rigorous process, there will be outliers in the real world (for example, we would once in a while run into unprocessable PDFs which had embedded entities). But the software I wrote in this span had an incredibly low defect rate. By the time it had reached production, it went through several cycles of informal testing, formal internal testing and validation, and then customer testing and validation. Also true: this doesn't work for all types of software. For consumer software, I'd release that last stage incrementally instead. Incorporation of automation is absolutely critical; in my quest to speed up this process, I ended up spending a lot of time experimenting with E2E test automation[1] to focus our test and documentation efforts. [0] https://www.fastcompany.com/28121/they-write-right-stuff https://www.fastcompany.com/28121/they-write-right-stuff [1] https://youtu.be/RGu0ta6MN1k https://youtu.be/RGu0ta6MN1k, https://youtu.be/qYkphCJjD_k https://youtu.be/qYkphCJjD_k, https://youtu.be/i-sMXPV547s https://youtu.be/i-sMXPV547s, https://www.linkedin.com/pulse/v-word-how-technology-decisions-can-streamline-validation-chen https://www.linkedin.com/pulse/v-word-how-technology-decisio...