Automation Integration Layer for Pharmaceutical Manufacturing

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.

AIL is a vertical data integration middleware to integrate shop floor to MES, ERP, and other IT platforms. A scalable software platform starting from data integration to plant historian, exception handling, audit trail, recipe management, and reporting and workflow management. It will extract, consolidate, and evaluate your existing data to develop a new network among your current technology and supports your digital journey to a connected plant.

A secure cyber connection from one central gateway for legacy machines

The rise of cybercrime in the pharmaceutical industry makes security a critical priority in its manufacturing technology. Protect your research and development insights and production data through features such as:

Designed with future-proof compatibility in mind, zenon updates regularly while allowing for production to continue.
zenon offers expansive user administration features as well as Active Directory support. You can link zenon authentication to Windows user authentication and easily configure data access levels.
At every stage of communication, zenon will extensively encrypt your manufacturing data if your connected machines support the technology. This encryption will protect the information used within your company network and through mobile access.

Availability of data in electronic format in a central location

zenon connects different equipment out of different disciplines and converts all data into an electronic format by a wide range of connectivity options. With more than 300 ready-to-use plc and logic drivers, it does not matter if you connect different types of plc´s or any sensors out of the field level.

Software gateways like OPC UA Server or dedicated connectors to MES or ERP level provide easy data exchange with upper-level systems.

Historical data of GMP relevant process variables incl. Alarms and Audit Trail is stored within a centralized data storage, ready to be used by other departments like QA for batch review or statistical process control.

Higher production success rates

Instant centralized notification about any deviation of a GMP critical process parameter of the connected equipment is provided.

zenon immediately notifies the right people who can take action. It also enables the user to create an exception report for simplified batch review. Exception reports are easily generated, this simplifies the batch review process.

These features will help you to promote product quality and reduce rejected products and reduces the time for a batch to be released.

Easy to comply with data integrity regulations also on old and existing machines

Reduce Headache for Quality Assurance and be prepared for an inspection.

The zenon AIL's parameter tracking and data recording features allow for data integrity compliance out of the box and provides an easier life for quality assurance. You can centrally monitor and log GMP parameter changes and receive instant notifications when one of these values changes without authorization. zenon´s recordkeeping capabilities store the data permanently on a central location. This is also simplifying the Backup and Restore operations and required by regulations.

Recorded data can be easily distributed across the company using web technology or via predefined reports as pdf.

In this way, important information like audit trail or exception detection can be easily handled by the QA department during the batch review.

zenon complies with FDA 21 CFR Part 11 and Annex 11

More efficient validation due to GAMP5 SW Cat. 4

The zenon Software Platform is a configurable product according to GAMP5 SW category 4. This reduces time and costs for validation. The clear project structure provides a good overview and you are able to keep all project know how in-house.

Stay independent from suppliers and keep operational information classified.

The history of change, integrated within the engineering environment, tracks all modifications done within the separate project versions, providing documentation for the change control phase according to GAMP5.

A documentation wizard documents all the configuration settings of the project for an easy creation of the documentation required for the validation process.

Solutions from COPA-DATA

With the zenon pharmaceutical digitalization layer, you can streamline your legacy machines and modern software to improve efficiency and agility. COPA-DATA has more than 30 years of experience in software development and continually updates zenon to adapt to changes in technology.
For more information, contact COPA-DATA today.

Industry Management

Life Sciences & Pharmaceutical | Process Industry

Features explained

zenon Logic

zenon Logic comes with Logic Studio, a programming environment that complies with the IEC 61131-3 standard. This means that it is flexible. The code is compiled and then runs in Logic Service as a virtual PLC. This means that it is fully integrated into Engineering Studio, which makes setting up projects easier and more reliable.

Audit Trail

Custom audit trail implementations require extensive development, validation documentation, and ongoing maintenance. And one gap in your tracking? That's a regulatory finding waiting to happen. zenon already meets the requirements of the FDA 21 CFR Part 11 and EU GMP Annex 11 regulations.

PAS-X MSI interface

zenon's certified MSI interface makes it easy to send batches of data between PAS-X MES and your equipment. It can also send GMP alarms to the MES. This certified integration helps reduce errors, speed up batch release, and minimize downtime between batches, while delivering the flexibility required in modern life sciences facilities.

FAQs

Yes, the zenon Automation Integration Layer (AIL) is specifically designed to integrate legacy equipment. It uses over 300 native drivers to connect to older PLCs and machines without requiring you to replace existing hardware. This allows you to modernize brownfield facilities and bring them into a connected Industry 4.0 environment by breaking up data silos.
The zenon Automation Integration Layer (AIL) ensures data integrity out of the box. As GAMP5 Category 4 software, it includes built-in features for user access control, audit trails, electronic signatures, and historian functions that fully comply with FDA 21 CFR Part 11 and EU GMP Annex 11 regulations.
Absolutely. The Automation Integration Layer (AIL) serves as a vertical data bridge between Operational Technology (OT) and Information Technology (IT). It aggregates and contextualizes production data from the shop floor and shares it with MES, ERP, and cloud systems using standard interfaces like OPC UA and REST APIs.

The Automation Integration Layer (AIL) simplifies validation because it is a no code / low code software product based on open standards, rather than a custom-coded solution. It comes with validation documentation wizards and project change tracking, which streamlines the qualification process (IQ/OQ/PQ) and reduces the validation effort by up to 80% compared to custom scripts.
The Automation Integration Layer (AIL) is a middleware solution powered by zenon software that bridges the gap between shop floor equipment and IT systems. It connects legacy machines and modern devices to upper-level systems like MES and ERP, creating a unified data network for your entire pharmaceutical production facility.
zenon ensures data integrity by centrally tracking GMP-critical parameters, recording all changes with a secure audit trail, and detecting unauthorized modifications. Data from legacy equipment is collected, time-stamped, and stored in a controlled environment. This approach supports regulatory expectations for data accuracy, completeness, and traceability.

Information material

Automation integration layer for pharmaceutical manufacturing

Digitalization_AIL_SL_EN.pdf
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Automation integration layer for pharmaceutical manufacturing

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