System integration: the next strategic advancement in pharma manufacturing

The three main trends that are shaping pharma industry

Pharmaceutical manufacturing is set to experience significant advancements over the next five years, as new trends in medicine are driving the need for system integration. 

Seamless integration, the driving force for regulatory evolution

At the heart of the system integration process lies a critical driver, regulatory evolution, which is prioritizing data integrity, traceability and real-time monitoring.
Guidelines such as FDA’s 21 CFR Part 11 and EMA’s Annex 11 continue to expand, demanding robust systems for electronic records and signatures. The emphasis for these frameworks has shifted towards seamless communication between production equipment and higher-level systems like SCADA and MES, driving the demand for smart equipment.

At the same time, regulatory bodies are actively promoting continuous manufacturing, which necessitates a seamless integration of SCADA and MES systems to monitor Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) in real-time. Data exchange between equipment and SCADA systems is essential to maintain production consistency while meeting stringent quality requirements. Continuous data logging and advanced visualization tools allow manufacturers to detect even the slightest deviations and take immediate corrective action.

As expectations for system integration grow, secure communication protocols between equipment and SCADA/MES systems are becoming a critical priority. Cybersecurity measures, such as data encryption and secure network architectures, are crucial to defend sensitive production data and prevent disruptions in operations.