Data Management Considerations When Launching An Environmental Monitoring System In A Pharmaceutical Manufacturing Facility

Effective contamination control in pharmaceutical manufacturing heavily relies on efficient data management. In a typical manufacturing facility, numerous critical tasks must be performed and documented to ensure the product remains uncontaminated.

Often, documentation is done on paper, leading to dispersed information across various databases and physical files, which can be difficult to access. This lack of accessibility hampers the ability of those responsible for environmental monitoring to assess current conditions and plan for the future, a process known as trending. Conducting trending with paper-based systems is nearly impossible.

To verify that manufacturing processes were executed as planned, critical data must be compiled and validated, often resulting in thousands of printed pages. Comparing data from different sources is a time-consuming task, requiring many hours or even days. Given the volume of data, managing this on paper is no longer feasible for mid-sized pharmaceutical companies. Consequently, current regulations mandate that pharmaceutical manufacturers perform trending using computerized systems.

Continue reading to learn what data management factors to consider when launching an environmental monitoring system in a pharmaceutical manufacturing facility.