Known Issues and Release Notes

[d_addams]

Are there typical practices for customer facing disclosure of known issues or release notes?

I'm thinking things like, 'using the underscore character in the User ID login field result in an error', 'double clicking button X when selecting which report to print causes the app to crash requiring a restart' (or fixed a bug related to such behaviors in release notes). This topic has come up a few times and sometimes it is represented that this 'normal', yet we've not established a way to make such notes available for customers. None of the items would be considered critical or safety related as they are annoyances or generalized quality complaints (the app crashes frequently during the account registration process which is really frustrating) which do get captured in our monitoring processes.

 

[yodon]

I'm not aware of any standard practices. When making a submission with software to FDA, their guidance expects the known anomalies to be documented along with a risk assessment. We typically include this in release documentation - which could be made available to customers. That's just a snapshot in time, though. You could have a web page, I suppose, if customers are actually asking for it (I don't know of any requirement to have an up-to-date list always available).

Of course, if any issues do pose risk, there are certainly other reporting obligations - both to regulatory bodies and to customers.

 

[Tidge]

My experience with one company (medical devices which included software) was that there was never really a disclosure of the anomalies list to customers. If an anomaly drove a correction, that company would eventually disclose it when a fix was rolled out (and then disclosed), and it was pretty straightforward to track updates to equipment. This was practical, but it should be possible to recognize that this approach would lead to several anomalies never getting addressed.

That company did eventually try to release a new product with a particularly gruesome/embarrassing customer-facing software anomaly... by "disclosing the anomaly", but the regulators looked at it and said "go ahead and fix that." The defect/anomaly was gruesome in the sense that the UI wouldn't be usable under semi-regular circumstances and embarrassing because the team lacked the knowledge how to fix it before submission. My sense was that the regulators picked up on this, such that whatever rationalization was offered fell on deaf ears.