Not every warehouse management system is created equal, particularly when it comes to the pharmaceutical industry. Due to the nature of the product, your wms system requires specific functionality to ensure good manufacturing procedures. For example, tracking batch, lot, and expiry dates are critical for the safety of your product. The right warehouse management system can help you stay compliant with your acceptance activities, labeling, shipping, storage, quarantining and security.
A company recently received this 483 observation:
ā¦.. Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Specifically, the warehouse management systems used for the receiving and distribution of raw materials, components and finished drug products such as … and the … were not validated for its intended use. There is no assurance that information inputted into the systems are reliable or prevented from deletion or alteration.
While this observation occurred in July of 2020, an identical observation occurred in January of 2021 as well.
There are several companies on the market that specialize in warehouse management systems for pharmaceutical companies. Microlistics and Datex are two companies that offer a pharmaceutical-specific warehouse management system. These wms systems are crucial when it comes to the storage of pharmaceutical products, and using a pharmaceutical-specific system can help keep you compliant with the FDA.
For more observations pertaining to data integrity, including warehouse management systems, see Issue 1044 and Issue 1056. It also has observations pertaining to lab controls, manufacturing controls, and medical devices.
NOTE: This post was originally published in July of 2020, but was recently updated to include the latest information related to warehouse management systems.
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