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Object documentation Stability Study 

Definition

A quality notification of the notification type QS or QR, which serves as the central object for the stability testing of physical samples.

Use

Business View

A stability study documents a request to examine and test a substance or product over a specified period of time, to examine the effects of different storage conditions on the characteristics of this substance or product. A stability study is usually conducted over an extended period of time to determine the long-term effects of these conditions.

Technical View

The stability study is represented in the system with the help of a quality notification. The quality notification is the business object that is used to process and manage all of the activities that relate to a stability study. You use the standard functions for creating and processing quality notifications to create and process stability studies.

The system provides the following quality notification types for use in stability studies:

  • Notification type QS (for stability studies conducted with reference to a material)
  • Notification type QR (for stability studies conducted without reference to a material)

These quality notification types have all of the necessary settings for creating and processing a stability study in the standard manner described in this documentation. If necessary, however, you can customize the quality notification type and the functions of the quality notification's action box to adapt the process to your company's specific requirements.

You trigger the different steps in the stability study process using a selection of predefined follow-up functions in the quality notification's

Structure linkaction box. These follow-up functions are sorted in a logical sequence, to allow you to perform all process steps in the proper sequence from a single point.

Integration

When you execute various process steps in a stability study, the system can automatically assign the following additional objects to the study, depending on which steps are performed:

  • Initial sample
  • Documents
  • Stability bill-of-material (only possible with quality notification type QS - stability study with reference to a material)
  • Inspection lots for initial test and stability tests
  • Stability samples for storage conditions
  • Testing schedule

You can display information about these objects and their links to other objects using the follow-up function Display objects for study in the action box.

Structure

For a description and structural view of the stability study object, refer to the

Structure linkquality notification.

See also:

Structure linkQuality Notifications Leaving content frame