Stability testing

Dawid Kaczmarek Updated by Dawid Kaczmarek

When the standard quality settings have been defined, CEPHEO Quality Sample Management for D365FO adds the possibility to perform time-dependent stability testing, based on certain parameters. This is incredibly important when working with any kind of biological materials as degradation happens naturally.

This feature works independently of the normal quality association trigger, as it is triggered by the registration of a sample in the sample handling system. In many companies, samples are automatically taken during manufacturing and brought to the lab and registered, and in some cases, it is necessary to handle the sample differently to measure various values. The test groups define what must be tested after the specified number of days.

In the Released products form on the ‘Manage inventory’ tab under ‘Quality’ a button is available to set up ‘Test of stability’. The system is based on a basic counter that is triggered at a sample registration.

If we look at the figure below, it basically says that ‘For every 10 samples registered, starting from the first and counted per batch number, you must create 3 quality orders. Planned in time with one 30, one 60 and one 90 days after the date of registration.

The field ‘Frequency type’ can be changed to ‘Days’ instead meaning that the first time every X number of days a sample is registered in the laboratory, the quality orders will be created.

The field ‘Sequence’ can be set to Batch or Product, specifying that counting is done per batch number or per Product ID.

The field ‘Sample Start-up Number’ defines when in the sample sequence the stability tests must be created.

‘Number of days’ defines the date, where measurements must be done for the specific tests specified by the ‘Test group’, test groups used can be the same all along or different test groups for the later stability test.

To ensure that planned stability test dates are valid, when planning, there is a calendar associated with the planning function. This is defined under Quality/Setup/Advanced quality control parameters.

Figure 91: Stability test setup

To ensure that planned stability test dates are valid, when planning, there is a calendar associated with the planning function. This is defined under IM\Setup\CEPHEO Quality Sample Management parameters.

Figure 92: Quality order calendar

As stability testing can be set up to take place sometime in the future, remember to maintain the calendars in advance for so long time ahead, that the timeframe for all stability testing to be created are covered.

How did we do?

Advanced quality associations with ref type different from ‘Quality sample’

Printing of sample labels

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