This is not the example readers need to understand, because the failures were so rudimentary and systemic that it seems "good process" is the answer.
Having written and validated both FDA and CLIA software, I'd suggest that process is never sufficient.
Plenty of well-meaning people will create and follow incomplete plans and hand-wave away issues when they sign off -- particularly people who gravitate towards rule-based, formulaic work in a hierarchy.
You need people both capable of and willing to seriously question whether proof is really proof, and who will stand up for some random patient in the distant future over their boss and colleagues on a deadline -- and yet they cannot be oppositional or egotistical, and must have deep insight into the subject matter.
It's really, really hard to find those people.