Accelerate IT-OT Integration Effortlessly
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Q&A Summary
How does the zenon automation integration layer ensure compliance with regulations like FDA?
The zenon AIL supports compliance by offering features like audit trails, electronic signatures, and user access control, which align with regulatory requirements such as GAMP5 and FDA 21 CFR Part 11.
Regarding alarm management, are you already ISA 18.2 compliant ?
Yes, zenon by COPA-DATA does support alarm management in line with the ISA-18.2 standard. Read more here.
I really like the idea of a Automation integration layer. But how to convince customers to invest? Its a backbone not a feature. "We built this layer so we can build other things faster" is hard to sell. Of course its a use case accelerator but it does not deliver value directly. Any recommendations?
More on this in the recording at: 53:00
Implementing review by exception (RBE) digitally offers a significant advantage. By using zenon drivers to integrate with Level 2 systems, and leveraging the Automation Integration Layer, you can enable RBE within your MES. This helps accelerate batch release, save time, and outperform traditional paper-based batch records.
When running a continuous process, can the system accept events such as raw material lot to lot change. In liquids, there can be batching process to feed continuous processes. It would be relevant for process condition changes seen and sensor measurement and models
Every event you can detect from the OT can be included in the Automation Integration Layer. Those Events can be classified according to specific request/events e.g. opening a new lot, in case of a change of a specific process value. For a more specific answer please get touch with us directly. Contact us for more: pharmaceutical@copadata.com
Did you stop your manufacturing operations to install the MES (Pas X in this case)? If so, for how many time? if not, how did you handle it?
More on this in the recording at: 52:00
Yes, it's important to plan for some downtime when installing an MES. We took a phased approach, implementing the MES in specific areas to avoid impacting the entire operation. Extensive validation activities were carried out in advance to minimize disruption. The goal was to reduce downtime to a minimum — ideally, just micro-downtimes. Read more here.
Can SAP be part of this AIL? One of our client uses both MES and SAP and wants zenon integration with both.
zenon offers a native SAP connector sending data in both directions! So AIL can be directly connected to SAP and other ERP systems.
About IT-OT integration but related to organizational changes, what is your recommendation to organize it? upgrading OT team (Automation), Using IT Team or creating and independent group in between IT and OT?
Establishment of a combined group of OT and IT-experienced employees. Create a common understanding of the topic of IT-OT convergence. Don't forget to involve the QA department as well.
When an alarm arises, how it is managed in terms of Deviation Management?
You can classify the alarms according to specific classes such as GMP critical ones. Then according to the classification how to manage the alarm, and how to handle it e.g. sending it to the EBR/MES.
Thanks a lot. Very interesting. We tried to do this link/gateway between Automation and MES with OSI-Pi but we were limited du to the fact that OSI-Pi is time-series based + OSI EF Module to store batch context but the rest of data was difficult to integrate (Alarm, event audit trail).
Thanks for sharing your experience. This is where AIL helps you in future. Read more here.
Almirall is a leading skin-health focused global pharmaceutical company based in Barcelona that partners with healthcare professionals, applying Science to provide medical solutions to patients and future generations. Our efforts are focused on fighting skin health diseases and helping people feel their best. We support healthcare professionals in continuous improvement, bringing our innovative solutions to where they are needed most.
PharmaX Solutions is an IT consulting firm specializing in the manufacturing sector of life sciences. We provide a comprehensive set of zenon turn-key implementation and end-to-end lifecycle services. With deep know-how in integration and high flexibility, we ensure successful application implementation and operation. Our consultants, based in five European offices, serve a diverse clientele ranging from SMEs to large multinationals, handling both single-site zenon implementations and global roll-outs.
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Automation Integration Layer
In brownfield applications, the zenon Automation integration layer (AIL) for pharmaceutical manufacturing is the perfect solution to connect legacy manufacturing equipment to IT infrastructure while complying with data integrity regulations out of the box with a GAMP5 Cat. 4 Software.
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As middleware for the vertical integration of data betweenproduction systems and MES, ERP and other IT platforms, zenonprovides a scalable software platform for all data processes in thepharmaceutical industry