Company insight
Ringing the alarm: Unified data for GMP Annex 1 compliance
The EMA’s revised GMP Annex 1, fully enforced since August 2023, has intensified demand for alarm monitoring from sterile manufacturers, many of which, lacking a digital solution, are still wrestling with manual processes to achieve this. A successful collaboration between Aizon and OYTEC for a leading European pharmaceutical company shows how this regulatory requirement can be turned, in a matter of weeks, into a strategic advantage. To learn more, we sit down with Cristian Marfà, VP of technical sales at Aizon; Fran Puerto, team lead data consultant at Aizon; and Jordi Pujadó-Coll, technical director at OYTEC.
The 2023 revision of EU GMP Annex 1 has put a spotlight on alarm monitoring. Can you start by outlining how your recent partnership with OYTEC helped a client navigate this? Cristian Marfà: GMP Annex 1 requires alarm monitoring as part of its updated Contamination Control Strategy. Our client faced the challenge of achieving alarm monitoring across almost 50 different machines. OYTEC’s expertise in on-site machine connectivity was key here. They integrated sensors and devices seamlessly, capturing real-time data from all the equipment.
Jordi Pujadó-Coll: At OYTEC, we specialise in pharma digitalisation, so that’s really our bread and butter. For this project, we connected all the machines into Aizon Unify to ensure data flowed securely and in real time.
Fran Puerto: Aizon Unify is our GMP- compliant platform. Unify doesn’t just store data; it contextualises it, linking alarms to batches, processes and equipment. We began by auditing the site’s alarms – counting occurrences, grouping them by type, and categorising them into ‘GMP-critical’ and ‘non-GMP’ ones. This helped the client turn noise into actionable intelligence.
Many manufacturers view alarm monitoring as a box-ticking exercise for Annex 1 compliance. How has this project shown its broader value?
www.worldpharmaceuticals.net
CM: It’s quite common that a company starts with compliance and then uncovers a goldmine for improvement.
JPC: Seeing the data unified on site is eye-opening. Previously, alarms were siloed. Now, they can spot patterns. It’s empowering the team to move from reactive firefighting to proactive maintenance, all while staying compliant.
We’ve seen clients use predictive analytics to boost yields through optimised parameters.
JPC: The partnership amplified this. OYTEC handled the on-site connectivity, ensuring data quality, while Aizon handled the intelligence. The client is now requesting additional dashboards and discovering all the ways they can leverage their newly contextualised data. Annex 1
“Unify doesn’t just store data; it contextualises it, linking alarms to batches, processes and equipment.”
FP: And let’s not forget the analytics layer. Unify’s real-time capabilities let you run queries on the fly. Beyond alarms, clients can leverage unified data to unlock many additional efficiencies.
How does Aizon Unify go beyond basic monitoring to enable process improvements? CM: Unify is designed as a ‘GMP by design’ platform that aggregates data from any source. In this case, it broke silos across the site, providing a single view for all manufacturing data. Alarms aren’t isolated events anymore; now they’re tied to context, like batch ID or operator logs. And this foundation opens doors to advanced solutions, such as AI-powered predictive analytics with Aizon Predict.
FP: With data now clean and accessible, AI-driven models are a logical next step.
compliance was the entry point, but now they’re eyeing full digital transformation.
What advice would you give other sterile manufacturers hesitating on alarm monitoring? CM: I would say, don’t view it as a cost but as an investment. With partners like OYTEC and Aizon, you get compliance plus a slew of optimisation solutions, as well as AI-readiness. The savings and improvements really speak for themselves.
JPC: I agree. As is becoming increasingly apparent, contextualised data is the new currency in pharma. It goes beyond compliance into competitive advantage. And fewer alarms mean more focus on innovation. ●
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