Quality and regulatory · OOS, control charts, release data
An OOS result is holding the batch, and the investigation has been stuck for weeks.
OOS investigations and release data closed faster, with traceable reasoning.
Who needs this in your company
What we can do
We put an OOS result in the context of your batches, check the raw data, maintain control charts and assess system suitability per USP <621>. For the product quality review we summarise the release data.
What you get
- OOS in the context of the batch history
- Raw data review
- Weighted root-cause hypotheses with a confirming experiment
- Release overview for the PQR
Typical cases
Close OOS investigations faster and with full traceability
We have an OOS result, the batch is on hold, and the investigation hasn't reached a conclusion for weeks.
See solutionClear the batch release backlog: review release data
Batches pile up before release because reviewing the data takes days every time.
See solution
Evaluated for you or done yourself
The same calculations, different ways to you. Which one fits, we work out in the intro call.
Evaluation report
You send the data, we deliver the reviewed report.
From EUR 1,490 net, typically 5 working days after complete data
Learn moreCovaSyn in your AI (MCP)
The same calculations directly in Claude, ChatGPT or your own AI.
Learn morePilot project
One question on your data, with a success criterion agreed in writing beforehand.
From EUR 1,490 net, fully creditable
Learn morePartners and academic
For software and instrument partners and for research.
Terms per partner, academic free on application
Learn more
Limits of the result
- Invalidation and CAPA are decided by your QA under its SOP.
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Next step
Which case is on your desk right now?
30 minutes on Microsoft Teams with the CovaSyn team. If it is not a fit, we will say so.