S.M.B. is a Belgian based pharmaceutical company with global ambitions. In 2011 S.M.B. decided to replace its ERP system that no longer met the business needs. An important decision criterion in S.M.B.’s choice of a new ERP was the system’s standard functional support of strict pharmaceutical regulatory requirements. Also the implementation partner they were looking for needed to have a in depth knowledge of these specific requirements and also of the resulting implementation methodology. S.M.B. found a perfect fit in Microsoft Dynamics AX 2012 – in combination with an AX for Pharma Add-on- implemented by iFacto, chosen by S.M.B. for its experience in Life science automation.
The previous S.M.B. ERP system did not allow for real time inventory registrations. All Inventory modifications were managed manually and periodically. This changed when Microsoft Dynamics AX 2012 went live. All physical flows are now registered in real-time, reducing the risk for errors and making material requirements immediately visible.
An important aspect of any ERP implementation in the pharmaceutical industry is the management of processes that involve patient health risk. This requires a specific implementation methodology where software setup traceability and software release management play a crucial part in the success of the project. Also the typical industry regulations - GaMP5, FDA - need to be respected throughout the entire implementation process.
iFacto manages the system validation of the above requirements by use of a large set of industry test protocols and predefined document templates.
The validation documentation of the entire implementation life cycle (infrastructure, databases, software setup and parameterization, training, bespoke work,..) is afterwards also used as a reference for external system audits.
The previous S.M.B. ERP system did not allow for real time inventory registrations. All Inventory modifications were managed manually and periodically.
This changed when Microsoft Dynamics AX 2012 went live. All physical flows are now registered in real-time, reducing the risk for errors and making material requirements immediately visible.
On top of that, all physical registrations are now supported by online barcode scanning (goods reception, warehouse movements, production consumption, production output, shipments and inventory counting).
In the pharmaceutical industry accuracy of active ingredient (API) production consumption is critical in the quality process (right ingredients, approved batches, correct weights).
S.M.B. decided to use the AX for Pharma Dispensing Module for this purpose. This touch-screen application - linked to scales in the production area - manages weight tolerances, batch quality information and performs online registration of consumed components in the ERP system. The chosen solution also offers functionality needed for batch dispensing reconciliation (traceability of ingredient consumption, batch reallocation and scrap).
The implemented Quality Management module complies with regulatory requirements (GaMP5) and supports the registration of Lab test results (LIMS).
In the S.M.B. system this Quality module is integrated with all relevant supply chain processes (goods reception, production transactions, batch and container management, sample management,..) and takes care of the automated generation of Quality orders based on order- and inventory transactions. This also allows S.M.B. to compile the required “Electronic batch record” at the end of each production order.