If you are a life sciences organization in pharma, biotech, medical devices, or clinical trials/ supplies—you must identify and track each container of GMP-critical materials. While Microsoft Dynamics 365 Finance and Supply Chain Management does let you manage and track batch numbers and serial numbers, it does not map single product units like drums, bags, or bottles, within a batch.
To address this critical requirement for life sciences organizations, STAEDEAN adds a new 'sub-batch' tracking dimension that enables traceability at the container level. The solution also streamlines integration and data exchange with supply chain partners including 3PLs, CMOs, and serialization applications.
Sub-batches help organizations overcome the limitations of serial numbers (e.g. non-parent-child relationship between batch and serial numbers) and offer enhanced features, including:
a. Shelf advice date, best before date, and destroy by date
b. Desiccant expiration date
c. Sub-batch type
d. Status (blocked/ unblocked)
e. Reason code
f. Storage conditions
g. Container configuration
h. Cautionary statement
i. Restrictions and Restriction type
j. Use code (the system checks the use code against the intended use of the transaction and returns a warning/ error message if the selected combination is not appropriate)
It is also important to note a critical distinction between serial numbers and sub-batch numbers: Serial numbers do not have to be unique so multiple items of different batches can have the same serial number, whereas sub-batch numbers must be unique.
STAEDEAN has executed multiple ERP implementations for Life Sciences organizations worldwide and recommends the use of sub-batch numbers to identify and track containers of GMP materials such as:
Our solution partly extends the serial numbers features in Microsoft Dynamics 365 Finance and Supply Chain Management and adds the following functionality:
STAEDEAN Life Sciences leverages in-depth industry expertise to enhance traceability, helping you achieve compliance seamlessly.