Can a modern biotech company really achieve operational efficiency if production data is isolated on individual machines? Is the right solution to introduce a central data repository and gain a single view of all alarms, events and measurements? What benefits can you expect, and how can such a solution be implemented at minimal cost?
These were the questions one of our clients faced while setting up a new biopharmaceutical production plant. They realized they would need to capture, store and analyze huge volumes of production data from different systems for both analytical and regulatory purposes.
The risks of fragmented production data
Equipment used in biopharmaceutical processes generates large amounts of data on alarms, events and production that, without centralization, remains trapped in individual systems.
Managing data directly on each machine is inefficient and creates unnecessary risk, because operators must know how to use every HMI, review data and handle reports that are specific to each device.
In a regulated pharmaceutical environment, machines must comply with data integrity standards such as 21 CFR Part 11 and EU Annex 11. Managing alarm, event and production data scattered across multiple HMIs is therefore a major challenge. Centralizing this data in a data repository turns isolated records into an easily accessible resource that enables operators to create customized reports for a single machine or for several machines together.
Achieving ALCOA+ compliance through a single platform
In cooperation with the Metronik team, the client decided that the best option was to implement MePIS PDM (Process Data Management), a modern solution for managing and analyzing process data and generating advanced reports.
The first step was to set up a central data repository to capture all alarms and events, and to integrate a process data historian to collect real-time measurements. MePIS PDM gives operators access to all production data through a single platform and removes the need to work directly on HMIs. This is a major improvement, as operators use just one application, which increases productivity and saves time.
The next step was to create comprehensive, customized reports for alarms, events and measurements. Instead of multiple separate reports from different machines and systems, data is correlated, which makes storing documentation for regulatory compliance much more efficient. MePIS has a unique capability to capture report data generated on devices at the end of a batch and place it in the correct context, regardless of how complex the data set is. Each report follows a defined review and approval process, where the client can assign different people to check reports before they are archived.
At the same time, MePIS PDM provides a complete overview of equipment status, real-time process tracking and data analysis for both in-process and completed batch data.
For a biopharmaceutical manufacturer, MePIS PDM represents a comprehensive and agile solution that ensures full regulatory compliance with the review and archiving of executed batches.
All collected data follows ALCOA+ principles, allowing users to focus on production instead of worrying about the risks related to data management, integrity and compliance.
If you are thinking about how to ensure full data traceability, compliance and greater operator efficiency in a new or existing pharmaceutical production plant, a centralized approach is the right choice.
For more information on how we can support you, get in touch with Metronik’s expert automation and digitalization team for the pharmaceutical industry, which in the last three years alone has integrated more than 300 production systems from over 50 original equipment manufacturers into MePIS.
For more information, please contact us at sasa.sokolic@metronik.si.
