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Empowering Digital Transformation in Pharma Manufacturing through Pharma 4.0

Digital Transformation and Pharma 4.0

Pharmaceutical manufacturing industry faces several pressures that are impacting its ability to bring safe and effective medicines from R&D to market faster and overcoming issues like supply chain disruptions and competition. This needs to be done in a cost-effective manner without compromising on quality and efficiency. In addition, the pharmaceutical world is highly regulated and compliance management is both time-consuming and costly, while non-compliance can lead to significant fines or legal actions from organizations like FDA and European Medical Agency. The Food and Beverage Administration for example has the FDA 21 CFR Part 11 to regulate electronic records of all drug manufacturing data that needs to be available in the raw uninterpreted format for at least 7 years for audits.

The pharma manufacturing world is increasingly turning to the integration of digital technologies and automation to solve these problems. This approach has been termed Pharma 4.0, which is a concept that is borrowed from Industry 4.0. Basically, Pharma 4.0 involves the use of advanced technologies such as artificial intelligence, machine learning, robotics, and Industrial IoT.

Overcoming Data Challenges to Power Digital Transformation in Pharma Manufacturing

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Improve efficiency:

Automate processes and use data analytics to improve efficiency across manufacturing lines and locations.

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Innovate faster:

Use digital technologies to be more agile and quickly identify and recover from costly mistakes or unsuccessful endeavors.

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Enhance quality control:

Apply real-time monitoring and analytics to quickly identify and fix issues before they negatively affect quality.

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Increase regulatory compliance:

Automate regulatory reporting and quality control, and ensure the traceability of data to support regulatory compliance.

This will allow Pharma manufacturing to bring high-quality cost-effective medicine faster to market so that they can focus more on the research of new drugs.

Read our Blog on Empowering Digital Transformation in Pharma Manufacturing – Pharma 4.0.



The Enterprise MQTT Platform for Pharma 4.0

HiveMQ is the enterprise MQTT platform that lays a powerful foundation for Pharma 4.0. It solves data connectivity and interoperability challenges by providing a secure, reliable, and scalable data abstraction layer between OT and IT systems. HiveMQ helps Pharma manufacturers achieve digital maturity by integrating data from factory machines, systems and applications to enterprise and cloud platforms, enabling advanced data processing and analytics use cases. HiveMQ helps ensure that Manufacturers are FDA 21 CFR Part 11 and/or European Medical Agency audit compliant. HiveMQ also solves the data quality problems by supporting data modeling, normalization, transformation and contextualization.

The key benefits of the HiveMQ MQTT platform that is trusted by over 130 customers are:

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Business Critical Reliability:

Operate mission-critical systems reliably 24/7 with zero message loss and redundant clustering technology.

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End-to-End Security:

Ensure applications and data meet the highest security standards with end-to-end encryption and configurable security controls.

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Scalability to Support Growth:

Add any number of sites and scale to millions of connected devices seamlessly with a linear design for scalability

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Observable Insights:

Troubleshoot and keep all factory systems running as planned with tools and metrics for transparency and observability.

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Flexible Integration:

Focus on your core business instead of using developer resources with OT-IT data integration into enterprise applications and infrastructure like Apache Kafka.

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Simple-to-Deploy:

Achieve rapid time-to-value with a platform that is flexible enough to deploy on-premise, in any cloud, or via the fully-managed and feature-rich HiveMQ Cloud offering.


Data and Pharma 4.0

The first and most significant frontier to achieve digital transformation and Pharma 4.0 is data collection and movement. Data from Pharma manufacturing machines, processes, and applications is captured and stored via key ingestion technologies and needs to be moved from the OT side to the IT side, where it is stored in a data center or enterprise cloud. This data-rich environment enables advanced initiatives such as machine learning, AI, adaptive control, and digital twins. Here is an architecture of how HiveMQ enables pharma data collection and movement.

Data and Pharma 4.0

Read our Pharma Manufacturing Data Sheet for more information on our features and the benefits we provide to the Pharma Manufacturing Industry.




Powering Digitization in the Pharma Manufacturing Industry with IIoT and MQTT

Pharma manufacturing is making great strides in adopting Pharma 4.0 for Digital Transformation initiatives including cloud digital twins, analytics, machine learning and artificial intelligence. That said, pharma manufacturing still grapples with challenges that make it difficult to implement IIoT solutions including legacy equipment with proprietary protocols, unreliable connections and complex infrastructures. MQTT and HiveMQ can help.

Download our white paper to understand how MQTT technology overcomes these challenges. Learn about the benefits of HiveMQ’s MQTT broker and the additional features that Sparkplug can bring to power your pharma manufacturing Digital Transformation.