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Jun 09 at 02:59 PM

Stability Study- Queries on Cancellation of Partial/ Total tests & Manual Inspection lot creation


Dear Experts,

As per the Stability Study process mapping in SAP, we reached final stage in QAS system. User came up with 4 queries as below. Please guide on these points. ( LT= long teem, AC= Accelerated, IN= Intermediate)

1) In particular study , we have LT1 ( 30/65) , AC, IN, LT2 conditions.(30/75). In Study, client requires that if LT1 fails, he has to start LT2 condition test.

For the above, With Notification (N1) when we distribute the Sample qty to 4 Temperature conditions , it is giving mandatory selection of all 4 conditions to start the test , even we not select 1 condition also we are not going further to start study. When we start the study, system is creating maintenance item to all 4 temperature conditions.

We suggested client to start the test with 3 required conditions. If LT1 fails, we can start a new Notification for LT2 as a separate study. Client is expecting that there is only possibility to continue with initial notification despite of creating 2nd Notification ( N2) for LT2 incase of LT1 fails.

Please suggest any step that we are missing here to provide the solution to user.

2) Stopping the Active stability ( NOPR) study for a particular temperature condition from the 3 conditions, as user doesn't want to go further.

3) Stopping the Active stability ( NOPR) study for Total 3 conditions, as user doesn't want to go further.

4) Purpose of Manual Inspection Lot - in practical where we exactly use.

Your guidance will help us to clear the user doubts & assisting user complete the testing and OQ document in QAS system.

Thanks in advance,

Theja .K| QM Consultant