Defining the Start Date for the Stability Tests

Use

When you define a start date for the stability study, the system first checks to make sure all stability samples have been stored. If all samples have been stored, you can specify the start date and the system then automatically calculates all test dates for the entire duration of the stability study. The test dates are calculated on the basis of the data you maintained in the testing schedule.

When you execute the follow-up function to define the start date, the system proposes the earliest storage date that was recorded for a stability sample or storage condition. You can overwrite the system proposal, but you must make sure that the start date you enter does not lie:

  • In the future (beyond the current date)

  • Before the earliest storage date of a stability sample and therefore no earlier than the date when initial sample was received

Prerequisites

You have completed the testing schedule and stored all stability samples under storage conditions.

Procedure

  1. From the SAP Easy Access menu, choose Start of the navigation path Logistics Next navigation step Quality Management Next navigation step Stability Study Next navigation step Stability Study Next navigation step Change End of the navigation path .

The initial screen for changing a stability study appears.

  1. 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.

  1. In the action box on the right side of the screen, choose the follow-up function Define Start Date for Study .

A dialog box for entering a start date appears. The system proposes the earliest storage date for a stability sample/storage condition.

  1. If you want to specify a date other than the proposed date, enter the desired date.

  2. Choose one of the following options in the dialog box, depending on how you want to proceed:

  • Define Cycle Start, Save/Exit Notification

  • Define Cycle Start, Save/Change Notification

Result

The system calculates all test dates for the entire duration of the stability study. The duration of the study corresponds to the value you entered for the Scheduling Period when you created the testing schedule.

For more information on how to view or process the test dates, see Scheduling and Deadline Monitoring .