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Pharma Manufacturing

Project Scope:

  • Regulatory compliance requires data be kept and stored in original form for 7 years
  • Needed a solution that would protect the data from security breaches
  • Every factory was a snowflake, no centralized view of data

Key Wins:

  • Achieved regulatory compliance at all 15 factories with zero data loss
  • Laid the right secure and reliable data foundation to expand use cases
  • Connected 15 factories with a common data hub

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Leading Pharmaceutical Manufacturer Automates Compliance with HiveMQ

A leading pharmaceutical company with 15 manufacturing sites across the globe sought to digitally transform to meet business-wide goals. Those three goals were: to produce a reliable supply of quality medicine, expand their portfolio of products, and drive productivity to achieve more than 1 Billion in cost-savings by optimizing their manufacturing facilities.

The company needed to modernize in order to meet the business needs for improved efficiency, increased quality, and enable faster innovation while ensuring that the regulatory reporting procedures mandated by local and state governments didn’t become an undue burden to the business. The company realized one way to fast-track success in these endeavors was with a digital factory initiative.

Business Issue: Drive Real-Time Insights While Satisfying Regulatory Requirements

By transforming and automating their pharmaceutical manufacturing operations, they hoped to derive more powerful and actionable insights from their OT data while satisfying regulatory requirements.

A specific FDA regulation requires that any electronic data associated with the development and manufacturing of a drug be retained for up to 7 years. The data is required to be pristine, original, raw data, and the company set out to find a solution that would allow them not only to meet this requirement but also enable data-driven decision-making and improved efficiency across all 15 of their factories.

Digital transformation is always challenging, but pharmaceutical manufacturers face additional roadblocks due to the fact that they are highly regulated. FDA audits point out the need to connect equipment securely, reliably, and in a way that can be scaled to any number of factories.

The pharmaceutical company was worried about data loss, security breaches and more, and needed to establish the right data foundation to power several use cases aimed at meeting both their business-level and regulatory compliance objectives. They set out to create an interoperable data foundation that would give them a single pane of glass into all of their factories.

Technical Solution: Create a Reliable Data Platform with HiveMQ and MQTT

The company identified HiveMQ as the platform they could use as this central hub for data communication, to gather data from the edge, integrate it to cloud and enterprise systems, and enable bi-directional communication so data could then be sent back to the edge in a continuous loop to make improvements. HiveMQ makes use of the very popular IIoT MQTT messaging protocol which is an open standard and the de facto messaging protocol for IIoT because it was designed to be lightweight, bi-directional, and flexible.

The project considered a variety of MQTT platforms starting with some open-source offerings, but soon realized they needed an enterprise-grade solution that could support their use cases and business-critical requirements. They selected HiveMQ because it was supported by the established leader in the MQTT space and had the technical expertise to ensure five 9’s reliability, proven scalability to support many factory systems, and zero data loss. Having HiveMQ support available when they needed it was critical for them to ensure minimal or zero downtime.

The customer has achieved zero data loss with HiveMQ, ensuring they don’t lose any of the measurements they have to record for the FDA. They are able to show that all messages are recorded, nothing is lost anywhere, and have achieved the extremely high availability, resiliency, and reliable message delivery they needed with the HiveMQ platform.

The HiveMQ Platform connects thousands of machines in every factory enabling sharing and consolidation of data from OT to IT. A HiveMQ broker in each factory collects data from devices and connects to a centralized, enterprise HiveMQ broker deployed in the cloud for a global view of data across factories. This is creating a data pool to which further analytics could be applied.

Looking to the Future

The use cases will continue to expand in the coming months into predictive analytics, quality control, and further optimizing operations for improved productivity. HiveMQ has become a trusted partner, not only solving their technical challenges but also helping the pharmaceutical manufacturer to implement several additional use cases.