Electronic Data in Pharmaceutical Manufacturing: Reducing Operator Error (Series Part 5 of 6)
Reducing Operator Error
Reducing operator error is and always will be the goal of any system where human interaction takes place. This is seen on a regular basis in manufacturing. For example, it has been widely held for years that visual human inspection can be significantly flawed; hence, the development of highly-automated vision systems. Likewise, data collection and analysis are subject to the same forces. From instrument configuration to data calculations, virtually any manufacturing automation can yield benefits to both process efficiency and product quality, providing it is designed and validated to do so.
Maybe you’re wondering if all automated monitoring methods are equally acceptable to Regulatory Authorities? Regulatory bodies do not indicate which architecture is preferred in an environmental monitoring system, but they do ask for users to be compliant with the applicable governing bodies (21CFR11, EU GMP Annex 11, etc.), to have disaster recovery procedure, to manage the data in the safest possible way, and to acquire the data in a secure fashion. All of these goals are best achieved using industrial automation.
Thoughtful, well-designed and validated automation can be a helpful ally in clean manufacturing operations. When we allow it to work with the highest regard to product safety it can unquestionably free up human resources to handle other issues and processes that require our unique abilities.