In sterile pharmaceutical manufacturing, alarms aren't just disruptive buzzers, they’re critical sentinels that ensure patient safety. With the European Medicines Agency's (EMA) revised GMP Annex 1 now fully enforced since August 2023, the pressure is on for continuous, real-time alarm monitoring across cleanrooms and processes. Many manufacturers are still grappling with fragmented manual systems, but a new spotlight in World Pharmaceutical Frontiers magazine highlights how Aizon Unify is turning this regulatory mandate into a strategic opportunity.
Our latest feature, Ringing the Alarm: Unified Data for GMP Annex 1 Compliance, provides insight into the collaboration between Aizon and OYTEC. With compliance as a starting point, this partnership empowers pharma leaders to break data silos, contextualize alarms, and drive proactive improvements, while putting a host of new digital capabilities at their fingertips.
The Regulatory Wake-Up Call
Section 5.2 of GMP Annex 1 is crystal clear:
“Equipment monitoring requirements should be defined in “user requirements specifications” (…) Process and equipment alarm events should be acknowledged and evaluated for trends. The frequency at which alarms are assessed should be based on their criticality (with critical alarms reviewed immediately).”
Manual logs and delayed reviews are not enough anymore. Real-time acknowledgment, contextual evaluation, and trend analysis are now demanded.
From Silos to Real-Time Intelligence
Enter Aizon Unify: our pharma-native, GxP-compliant lakehouse designed from the ground up for regulated environments. In partnership with OYTEC, we delivered a solution that transformed alarm management for a leading European sterile manufacturer in under three months.
But the benefits don’t end with compliance. By breaking data silos and unifying and contextualizing data, Aizon Unify provides real-time visibility, enabling instant dashboard views and historical trend analysis, empowering teams to investigate root causes. As Aizon VP of Technical Sales Cristian Marfà explains in the article, “You get compliance plus a slew of optimizations. The savings and improvements really speak for themselves.”
As for the future, Team Lead Data Consultant Fran Puerto says it best: "With data now clean and accessible, AI-driven models are a logical next step."
Dive into the full article here.
