Managing pharmaceutical stability testing can be very demanding, especially with small to medium size companies developing and producing over the counter, generic and new prescription products. Some companies outsource the actual inventory management and testing requirements, but they are still required to track progress and report results as part of their QA or Development process.
Manually ensuring that approved protocols are followed precisely, including “pulls” being made on schedule with the appropriate tests being performed, can be both time consuming and tedious.
The laboratory must also ensure that any laboratory informatics system can interface with other enterprise system such as Enterprise Resource Planning systems (ERP) or Manufacturing Resource Planning Systems (MRP), etc. Enabling the laboratory to add value to the manufacturing process is key.