Setting up a multi-site enterprise architecture for MedTech company
PROJECT SUMMARY
The primary goal of the project was to establish a new 21 CFR Part 11 compliant multi-site enterprise architecture that links two production sites of a global MedTech company. In addition, Agidens equipped both production sites with their own historian in the Level 3 IT environment for secure data storage, and made the data accessible to predefined users and third parties.
Agidens also took care of the logging of the production machines’ lot data. Lot reports from the production machines are captured and can be accessed, printed and distributed to the relevant users.
PROBLEMS
- The MedTech company had a prominent need for a proper multi-site network architecture, including disaster recovery and automatic updating, that fully complies with their global cybersecurity requirements and 21 CFR Part 11.
- Building further on 21 CFR Part 11, data retention and redundancy were key for our client.
- A complete lack of digitally stored historian data.
- The old Windows XP computer with custom access database, used for logging production machines’ lot data, printing and reporting, needed to be replaced sooner rather than later.
SOLUTIONS
To address our customer’s needs regarding network and site distribution concerns, Agidens chose Ignition by Inductive Automation. “After thorough analyses and workshops, we decided to implement Ignition. Following numerous tweaks, this automation software provides the necessary functionalities and modules to transform into the desired network architecture for the MedTech company,” says Dries Smeuninx, Lead Automation Engineer at Agidens. “Another reason is the fact that the features were already aligned with 21 CFR Part 11, which was a critical topic for our client.”
Enterprise Architecture
A single overarching gateway now connects the two production sites of the MedTech company. The Enterprise Front-End Gateway (Level 4) provides an overview of the two production sites by presenting dashboards and reports on a copy of the data from both production sites.
LEVEL 2 & 3
The Level 2 OT environment at both sites includes back-end gateways that are connected to various devices and guarantee redundancy. This data is made globally available and stored in the historian via a secure gateway network.
The Level 3 IT setup features full stack gateways that collect all data and transfers it to the historian.
Groov RIO
Ignition Edge in OPTO 22’s Groov RIO, combined with a store & forward mechanism, safeguards historical data in the event of communication problems and guarantees that the central historian receives all data for long-term storage.
Digital logging
Another problem that Agidens solved, is the manual labor involved in monitoring the temperature during the product maturation process. Previously, 22 paper loggers were used to manually and visually check if a run was proceeding correctly. Both the temperature limits and the duration of maturation were continuously monitored by measuring the length of the paper. These papers were first checked by an operator and then verified by the validation team.
All this manual work is now eliminated because all historical data is available in the software automation platform.
HOW WE’VE HELPED
RESULTS
- The Level 4 setup always has a copy of the data from both sites. In the event of any problems, the relevant persons will be automatically informed.
- No more manual analysis: all system data is digitally accessible, offered globally via dashboards. The reports are automatically distributed to defined users.
- All data is 21 CFR Part 11 compliant and protected against data loss.
- Agidens established an enterprise software platform that can scale and grow with the needs of our customer.