Creating the Initial Sample (SAP Library

Creating the Initial Sample

Use

Once you have created a stability study, the person or organization requesting the study normally delivers the physical sample to be tested to your laboratory or testing facilities. This physical sample is referred to as the initial sample.

Note

The initial sample is the sample that you test first to determine whether the sample will be suitable for use in the stability study. If the results of the initial test are satisfactory, you can then create additional stability samples to be tested at regular intervals during the course of the stability study.

You can create the stability samples from the original supply of the initial sample, provided a sufficient quantity remains. Otherwise, you must request that an additional sample quantity be delivered.

In this procedure, you plan the receipt of the initial sample by creating a corresponding physical sample-record in the system. When you create the record for the initial sample, the system automatically:

Sets a status in the physical-sample record indicating that the initial sample has been created
Retrieves the following information from the stability study and proposes it for entry in the physical-sample record:

Physical-sample type (sample for stability study)
Physical-sample category (stability sample - initial)

When the initial sample has been created, the action is documented as a task in the quality notification.

Prerequisites

You have created a stability study in the system.

Procedure

From the SAP Easy Access menu, choose Logistics ® Quality Management ® Stability Study ® Stability Study ® Change.

The initial screen for changing a stability study appears.

On the initial screen, enter the key of the stability study you want to process and then choose Enter.

The screen for changing the stability study data appears.

In the action box on the right side of the screen, choose the follow-up function Create Initial Sample.

A dialog box for creating the initial sample appears. The group for physical-sample detail data in this dialog box contains proposals for the initial sample (physical-sample type and physical-sample category).

If necessary, change the system's proposal for the physical-sample type.
Enter data for the remaining fields in the dialog box, if required.
Choose one of the following options in the dialog box, depending on how you want to proceed:

Create Initial Sample, Save/Exit Notification

Create Initial Sample, Save/Change Notification

Result

A physical-sample record has been created for the initial sample. You can continue the stability study process with the following activities:

Change the initial sample (perform steps 1 through 3 in the procedure above, choosing the follow-up function Change Initial Sample instead of Create Initial Sample).

Confirm receipt of initial sample.

Assign a stability bill-of-material (BOM) to the stability study (if you are conducting the stability study with reference to a material).

Prepare for the initial test by creating an inspection lot for the initial sample.

Define storage conditions for the stability samples.

Create a testing schedule.