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The situation
A deviation is raised. The investigation asks what happened, why, and whether it has happened before. The first two are answered from the batch. The third is answered from years of previous investigations.
Those investigations are documents. They are titled by reference number and written in the language of their own time, so finding the related ones depends on somebody remembering.
Why it is hard
Similar is not identical
A recurring issue appears with different equipment, different products and different descriptions. Matching on title or code finds almost none of them.
The useful detail is in the narrative
Root cause and corrective action are written as prose, which is where the relevant comparison lives.
Recurrence changes the regulatory position
A repeated deviation that was closed as isolated each time is a worse finding than the deviation itself.
How we approach it
Agentix searches prior investigations by what happened rather than by code, and returns candidate precedents with the passages that make them comparable.
The investigator judges comparability. The system's contribution is ensuring the relevant prior investigations are in front of them.
What changes
- Prior investigations found by substance rather than by reference code
- Candidate precedents returned with the comparable passages shown
- Recurrence visible at the point of investigation, not at audit
- Investigator judgement and QA sign off both preserved
Next
Is this your problem too?
Bring the version of it you actually have. We will tell you what it would take, including when the answer is that it is not worth doing.