Discover how SAP system functionality can assist businesses in research and development (R&D) and product improvements. In certain sectors such as pharmaceuticals and the food industry, it is a legal requirement to document and maintain the data related to various tests carried over in the R&D phase for product approvals. Learn step-by-step configuration to realize a real-life business requirement related to the stability test of a product under different physical conditions during product development.
By reading this article, you will learn:
- Key functionalities and salient features of the SAP stability study feature
- The way a real-life business requirement can be covered with an SAP stability study
- Step-by-step detail configuration showcasing the way an SAP stability study can realize business requirements
An SAP stability study (also known as a shelf life study at times) is functionality in SAP ERP Central Component (ECC) under the Quality Management (QM) module. QM notification is the prime business object in a stability study. The entire process is managed through notifications.
As a part of its endeavor to address business requirements across industry sectors, SAP released the stability study feature to help in the product development and improvement phase. A stability study enables you to streamline the documentation required for product authorizations in the pharmaceutical, food, and beverage industries.
Before I cover the details of configuring an SAP stability study, I list the following advantages of managing it with SAP ERP:
- Most of the master data required for the stability study is already available in the SAP ERP Central Component (ECC) Quality Management (QM) module.
- Instead of using other third-party applications, businesses already using the QM module for other quality management issues can introduce ECC with minimal end-user training, especially for a stability study.
- An end-to-end stability study can be performed and documented in the same application.
- An accelerated business go-live and a minimal IT project investment are not needed as baseline configuration related to the QM module is already completed.
First, I discuss the design of a stability study in the SAP system, and then I elaborate on the functionality and configuration in detail. In a standard SAP system, there are three notification types available to support different types of stability study business requirements:
- Stability study without material (QR)
- Stability study with material (QS)
- Stability study for a trial (QT)
As the name suggests, stability study without material (QR) is used to conduct stability studies where components or ingredients are referenced, whereas in the stability study with material (QS), the components or ingredients of the stability sample are defined in the bill of materials and mentioned in the stability study. Stability study for a trial (QT) is used to conduct the stability study during the trial phase of the product research and development.
These three notification types are like any other notification types in that you can configure them using transaction code SPRO and also copy these standard notification types and further customize them as required. Notification is the central gateway to trigger and trace most of the business transactions related to a stability study. The stability study process is diagrammed in Figure 1.
The stability study process
As shown in Figure 1, during the initial stability study phase, a sample is tested to ascertain whether to continue the stability study. Generally, a stability study is conducted over a long period of time, sometimes even for years. Therefore, it is prudent to decide up front, based on the initial sample test result, whether to proceed for the full stability study.
In the stability planning stage, storage conditions under which samples will be stored are specified, the frequency in which these samples will be inspected is defined, and samples are stored in a lab as per the storage condition defined. In the stability tests phase, samples are tested as per the defined test dates or frequency in the planning stage and results from these tests are recorded.
SAP provides the option to have different inspection schedules and characteristics to be inspected for each stability sample maintained under different physical conditions (Table 1).