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Process documentation Initiating a Stability Study Locate the document in its SAP Library structure

Purpose

In this first phase of the stability study process, you create a record in the system to document your intent of conducting a stability study, and you prepare to receive and manage the physical samples to be tested.

Process Flow

The description below describes a recommended sequence for initiating a stability study. While step 1 must always be performed first, you can perform the remaining steps in the process in a different sequence, if necessary.

  1. You create a stability study by creating a quality notification in the system. This documents your intent of conducting a stability study.
  2. In preparation for receiving the incoming physical samples, you create a physical-sample record in the system for the initial sample.
  3. Upon receipt of the physical sample in the laboratory, you confirm the receipt of the initial sample.

    4. You can also perform this step at a later time. You must, however, have confirmed the initial sample before you inspect it.

  4. If you are conducting the stability study with reference to a material, you can assign a stability bill-of-material to the stability study.

This step is optional and can be performed anytime after you have created the stability study.

Result

When you have completed this process phase, you are ready to proceed with the next process phase, the initial test.

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