When companies adopt SAP for their usage, they rarely ever consider it a software suite that research and development (R&D) teams could benefit from. However, because of its robust documenting system, SAP serves as the ideal solution for pharmaceutical companies that are required to have a rigorous testing schedule that is well-documented. To this end, SAP serves as a useful addition to any company looking to have a solid documentary trail for their testing as well as managing their testing schedule and noting their results.
STEP 1: Creating Quality Notification
The first thing we’ll do is run transaction code QM01 and enter the notification type as QS with material. We will fill out the plant and material then hit Enter to bring up the batch number field. We’ll update the batch number and save it.
STEP 2: Create the Initial Sample
We’ll first run transaction code QM02. In the following window we’ll update the notification number that we want to deal with and hit Enter. The next screen allows us to click on Action then select Create Initial Sample. The following pop-up will prompt us for a series of information such as Sample Container, Primary Packaging etc. In this box there is also a place for Storage Location and Storage Condition. These fields are optional and may be ignored. Just as you would ignore certain fields on PowerPoint templates that don’t fit your design. If special storage is needed for the container, this should also be stated in the Initial Sample Setup. We’ll now save our changes.
STEP 3: Confirm the Initial Sample
We’re going to hit the Action button and select Confirm Initial Sample. The popup that shows up will outline our sample settings. We’re going to hit Save and Change Notification. A further pop-up will appear to confirm physical drawing of the sample.
STEP 4: Initial Inspection Lot Creation
Once again, we’ll hit the Action button and select Initial Test Inspection Lot. In the pop-up that follows, we’re going to update the Group Counter as well as the Group. For the Short Text we’ll state “Initial Inspection lot” and hit Create Inspection Lot. The next pop-up box allows us to choose the test we want to perform as well as the specifications we’re looking at maintaining. Either copying the selected test or Copy All works. The system will then create the Inspection lot.
STEP 5: Delineating the Storage Conditions
We’re going to click on Action, then Specify Storage Conditions which will create a pop-up. Here, we’re going to select the storage conditions we want to deal with and distribute the sample per quantity under these storage conditions. We’ll finish this step by hitting Save And Change Notification.
STEP 6: Develop a Testing Schedule
Under Action, we’re going to select Create Testing Schedule. In the pop-up that results, we’re going to select our Maintenance Strategy and edit the Scheduling Period value. We’ll complete this step by clicking on the Save And Change Notification button.
STEP 7: Change the Testing Schedule
Under Action, we’re going to select Change Testing Schedule. A prompt will follow asking us if we want to edit the testing schedule for the test and return to the test. We’ll select Yes. The Change Maintenance Plan screen pops up. We’re going to select a maintenance item and open up the Item Tab. The Item Tab should show the details of the current item while the tab next to it, the Cycle tab, should be empty. In the item tab we will edit out Group Counter and Group then check the cycle tab to be updated on what time we’re being assigned. We’ll do this for each Maintenance Item and click Save when we’re done.
STEP 8: Completing the Testing
We’re going to go to Complete Test Scheduling under Actions. The pop up that results will ask us if we want to complete the test scheduling and return to the test. We’ll select Yes.
STEP 9: Start Date, Monitoring and Reporting
We’ll be able to access and edit the start date for the study under the Actions button, with Define Start Date of Study. To monitor the testing, we’re going to have to set up a daily job to run in the background with transaction code IP30. Once all the pertinent systems have been assigned we can complete the study by selecting Complete Stability Study under the Actions button.