A Compliant, End-to-End Solution
Basing digital transformation on a scalable, modern DCS delivers significant benefits – in both the lab and on the production floor.
Most critically, a modern DCS provides an end-to-end manufacturing solution that lays the foundation for electronic batch records (EBR), validation and regulatory compliance.
Every biologic and pharmaceutical formulation developed in a lab is based on sequential steps. A Modern DCS with electronic batch capabilities replaces manual processes with sequential flow and phase transitions in a structured manner. And it captures, formalizes and enforces required workflows.
From a regulatory standpoint, an EBR improves accuracy and data integrity – and eases 21 CFR Part 11 compliance. Integrating the DCS with manufacturing execution systems (MES) drives even more regulatory efficiencies.
In fact, more companies are speeding the transition to a production environment by applying a modern DCS and gaining regulatory approval on small bioreactors in laboratories. When the product is ready to move into the commercial pipeline, the DCS can quickly scale up.
More Efficient. Future Ready.
A modern DCS can use analytics tools to convert raw data into actionable information that can impact operational and equipment efficiency from the lab through production.
For example, the system can analyze thousands of data points in a lab to quickly uncover correlations and causations that may otherwise remain hidden. On the plant floor, the modern DCS can deliver batch and equipment analytics to help keep systems running optimally.
Of course, a biologic or drug once produced by a limited number of facilities may one day be made by a network of contract manufacturing organizations (CMOs). By choosing a modern DCS from a recognized, globally supported automation provider, life sciences companies can more easily maintain consistent supplier selection downstream – wherever production occurs. And maintaining a consistent modern DCS worldwide helps allay concerns regarding repeatable production runs.
But these are just some of the ways a modern DCS can span across a product lifecycle. Learn more about solutions for the life sciences industry and the Facility of the Future.
The post was co-authored by Tim Schmidt, Global Process Marketing Lead, Rockwell Automation