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OOT Trending – a proactive measure
Identifying OOT results was a concern for the client for avoiding potential issues with marketed product, as well as avoid potential regulatory issues. The calculation of OOT trend for each every batch is complicated and cumbersome to perform manually or in excel sheets. There was a need for efficient and practical statistical approach to identify OOT results to detect when a batch is not behaving as expected. To judge whether a result is OOT, one must first decide what is expected and in particular what data comparisons are appropriate.
Based on the SOP the following decisions need to be made
• What statistical approaches are used to determine OOT criterion
• What data to be used to determine OOT limits
• What evaluation is performed if the minimum data requirement is not met
• What data should be used to update limits
• Who is responsible for comparing the result with the OOT criterion
Solution and Implementation
OOT calculations can be done on the fly in CaliberLIMS sample manager. OOT results are displayed to approver right after the sample analysis is submitted by the analyst. This helped the reviewer to do effective proactive measure in case there is an OOT for that batch.
CaliberLIMS has a capability of trending OOT in three ways:
• Running average
• Giving a minimum and maximum range
This has helped the client to configure OOT for different products as per their SOP.
The solution is very flexible, effective and reduces redundant calculations that are being done by the analyst. An analyst can give the number of released batches to be compared with, subsequently the system takes the result value of previous batches and apply to the validated predefined formula in one of the of above mentioned ways and calculate the OOT.
This OOT is calculated in real time as when the test results are submitted and it is flashed to the reviewer before approving the results. This is of immense help to the QC manger, the manager will know the trend analysis and once he OOT is triggered by the system, the decision of OOS can be taken. Proactively the manager can issue a CAPA in case deviation and improve the process or material so that the test results across bathes are consistent.
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