Hi Zach, Ellen,
My company Good Automation provides turn-key FDA compliant validation services. As you point out, a good solution is only half the battle. FDA requires that
"when [software is] used as part of ... the quality system, the manufacturer shall validate computer software for its intended use according to an established protocol...." (see 21CFR820.70i)
Part 11 regulations (21CFR11) and recent FDA guidance (Guidance for Industry Part 11, Electronic Records; Electronic Signatures — Scope and Application) essentially says when the software above either:
A) Keeps records as required by predicate rule requirements (is system of record for certain Quality System data) and/or
B) Lets users electronically sign documents (e.g. manager approval as required by predicate rules)
When either or both apply, FDA says you have to validate the system. This is easier to understand in the context of good documentation practices and good record keeping practices you would use for paper records. Taken with 820.70i above you can see Part 11 just says: "You can use a computer instead of pen and paper, just validate the system to your intended use - i.e. replacing the pen and paper".
Feel free to ping me directly if you have questions about software validation. Like everyone, I struggled when first grappling with these concepts. They seem complex but turn out to be straight forward once you have done a few of them. The key is to get very good at articulating the Intended Use statement. With that in place you next enumerate User Requirements. Then author a Validation Protocol, execute it, and author the Validation Report.
I teach classes on FDA compliant software validation. My company helps medical device makers write SOPs to control the software validation process. We also help them validate individual tools like JIRA.
Using a tool add-on like the one discussed here is a great first step but you still have to validate the final configuration to your intended use. Feel free to ping me if you still have questions. This stuff can seem vague at first but it gets easier.
PS: Sorry if this posted twice. It did not seem to post the first time.