Bromel QA Manager
Keeps what went wrong from going quiet. Deepest for shops whose customers audit them.
“HV-NCM-0001 has been on hold for 47 days: beeswax pastilles received with visible debris.”
The job
Every line below is a capability in the product, checked against the code that implements it.
- Raise a deviation, investigate it, and assign the investigation to a named owner
- Open a CAPA with owned, tracked actions
- Trace any lot forward and backward
- Generate a certificate of analysis
It brings you work, never actions
Nothing happens without your say-so. The refusal is machine-readable and enforced when the code loads — a developer who tries to slip an outward action past it gets a build failure, not a code-review argument.
Chases on overdue CAPAs and nudges on critical findings — neither of which a non-regulated shop is likely to trigger.
When it has nothing to say
Most software only shows you the good day. This is what this seat does on a thin one.
A regulated regime to be worth its full depth. 4 of its 6 finding keys are GxP-only.
A non-regulated machine shop trips only the universal nonconformance-ageing check. Real, but thin — this is the seat to be careful describing.