Laboratory Information Management Solutions

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:

· 3sigma

· 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.

 

CaliberLIMS lays a strong foundation for a demonstrable adherence product which is carefully designed for laboratories across industries to meet their qualifications.