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The production process involves receiving detailed drug formulations from leading pharmaceutical firms to manufacture medicines for the market. The organization follows a batch manufacturing process that involves a workflow of multiple steps including gathering raw materials, mixing ingredients, processing the mixture, conducting quality testing, and shipping the product to the packaging facility. This entire manufacturing process is highly automated, with Programmable Logic Controllers (PLCs) managing and controlling each stage until a batch of medicine is successfully completed. To establish optimal environmental conditions crucial for the manufacturing process, the organization relies on a Building Management System (BMS).
The BMS monitors and manages critical factors such as temperature, humidity, and airflow, ensuring compliance with regulatory standards throughout production. Additionally, the company employs a Manufacturing Execution System (MES) to track the supply, quality, storage, and utilization of raw materials. These systems are integrated to ensure operational efficiency and maintain the highest standards of quality in the pharmaceutical manufacturing process.
The IT infrastructure is the foundation of the production cycle. The organization's IT encompasses seven data centers spread across the United Kingdom, United States, and Denmark. The servers in these data centers support the collection and storage of all production and quality control data generated during the manufacturing process. IT teams monitor the batch manufacturing process through applications hosted on these servers, ensuring that operations run smoothly and efficiently.
The company has deployed Cisco UCS in its data centers for server needs, while for storage requirements, the IT teams utilize devices from leading vendors such as HPE, Dell, NetApp, and Synology. To safeguard its systems and maintain compliance with regulatory standards, the organization has implemented firewalls from Palo Alto. Given the complexity of its multi-vendor, distributed IT network, the company recognized the need for a centralized and robust monitoring solution. We spoke with the principal engineer at the company, who shared valuable insights on the transition from other vendors, including SolarWinds, to OpManager. This shift enabled the company to maintain peak performance across its network, achieving 24/7 availability of applications, which is crucial for its business operations.
The principal engineer highlighted that the company’s network encompasses two separate systems: the Enterprise System and the Operational Technology (OT) system. The Enterprise System includes Tableau servers, HR application servers, and end-user devices like laptops. On the other hand, the OT system comprises mission-critical components such as the BMS, MES, PI System, and PLC machines. The applications connected to the OT category are essential for production, and any downtime could halt operations entirely, resulting in significant financial losses.
When asked how an outage could impact its operations, the principal engineer explained, "It depends on the system that goes down. If the Enterprise System experiences downtime for a few minutes, we can manage it. But, when an OT system fails, it triggers organizational panic, as it can halt the production completely, which can cost us millions of dollars." The key challenge for the CDMO is to ensure that the OT systems are operational and performing optimally 24/7. To address this challenge, the CDMO utilizes OpManager to monitor both environments.
The decision to transition to OpManager proved highly beneficial and demonstrated that the investment quickly delivered a positive impact for the organization. OpManager addresses the company's specific challenges by providing:
With OpManager, the IT team gained multiple functionalities from a single interface at an affordable price, resulting in significant cost savings. The principal engineer noted, "A major benefit of using OpManager is the licensing costs; we now pay one-tenth of what we previously spent on other products." Monitoring applications that oversee batches is crucial, as any unresponsiveness from the associated application could lead to batch failure. These failures can pose a serious financial threat, with a single incident potentially costing up to $1 million as estimated by the principal engineer. However the CDMO is now able to efficiently prevent utilizing OpManager.
"With OpManager's alert notifications, we can identify sluggish performance much earlier, prevent crashes, and proactively address issues before they lead to a batch failure," the principal engineer explained. The troubleshooting costs also decreased significantly with the implementation of OpManager. Before using the tool, the company relied on external consultants to diagnose issues on-site. The principal engineer estimates that hiring a consultant could cost about $150 to $200 per hour, with a minimum of five hours required to troubleshoot an outage, observing: "You can calculate the costs and it comes to at least $1,000 just for the consultant to analyze the situation and identify the issue, which adds financial burden to the our organization." Even when the company did not hire external consultants and sent an in-house employee to troubleshoot issues, it still faced potential productivity losses.
The principal engineer explained, "When we sent an in-house employee to troubleshoot, we not only incurred travel costs, but the employee also had to invest a significant amount of time on the road to reach the site and to diagnose the issue. This time could have been spent on more meaningful tasks and strategic initiatives that drive our business forward."
The user-friendly interface facilitated a quicker learning curve for the team. The principal engineer emphasized that even those not from the IT team found it easy to use: "OpManager was simple to navigate, making it easy for us to train members from application team, and they were able to use it effectively without any struggle."
Before adopting OpManager, the organization relied on various open-source tools, which often lacked the necessary support. With OpManager, the CDMO experienced timely and effective support services. "We used many open-source tools before, but they offered no support. With OpManager, we receive prompt assistance. Additionally, we also have the option to request features, and they often appear in upcoming releases." The principal engineer mentioned the Dell VxRail HCI feature as an example for this, observing, "We were already using the VxRail environment, and when we requested to extend monitoring support VxRail, it was included in the next major release".
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