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So far in our blog series on our position as a challenger in The 2022 Gartner® Magic Quadrant™ for Manufacturing Execution Systems (MES), we’ve covered how composability is redefining MES, and we’ve described the different personas and frameworks that manufacturers require if they want to build a composable business that enables citizen developers.
But in life sciences manufacturing, different challenges mean different reasons and different requirements. Let’s take a deeper look at real-world examples of how composability can play out in life sciences, including challenges and solution requirements.
Why Composability? Why Now?
We know that composability is on the forefront of manufacturing innovation not only because we support it. We know it because of what’s happening in the life sciences industry today, including:
Market disruption with COVID 19 making clear the need for agility
Workforce disruptions, such as people leaving and staying shorter periods of time
More customized therapies (smaller batches, devices tied to patient), which create a need for traceability, error-proofing and error-checking
Continued focused on GxP compliance
These trends have implications for life science. They tell us not only that composability is a requirement, but also what fulfilling it may require in practice.
What are the Requirements for Composable Solutions in Life Sciences?
Whereas general manufacturing leaders might focus on productivity and efficiency, life sciences demands focus on compliance, which elevates the importance of governance. Manufacturers in pharmaceuticals, biotechnology, and medical devices are forever committed to quality — so once you define a process, you also have to ensure it’s being followed.
Requirements for a solution include:
1. Appropriate governance depending on use case
Wouldn’t it be excellent to never have to worry a process could proceed if a certain step or quality check were missed? If you have appropriate governance built into a platform, error-checking turns into error-stopping in a moment.
2. Standardized data collection for GxP
Consider electronic batch records and digital history records, for example. Any solution you build should prioritize standardization. In other words, it should be built for your requirements.
3. Build for auditability
And those requirements should include the requirements of your regulatory bodies. If your operation answers to the FAA, you should roll out solutions built for tracking and auditing the data and the processes that matter to the FAA.
In addition to holding tight to these specific solution requirements, life sciences manufacturers should also keep the composable philosophy up front. Solutions should empower the people closest to the work. That’s a fundamental belief of ours at Tulip.
When you consider what solutions to roll out, you should center people and process in decision-making. Meaning, you should assess a solution’s value to your operation from the inside-out. Rather than considering the strict capabilities of the solution first, consider the needs on the floor first. That’s how you’ll be able to build what matters most for you.
Lastly, when you do have a best practice or solution that’s broadly applicable, you have to be able to roll that out across sites or use cases, still with the appropriate governance measures.
Meeting Composability Challenges
We’re making it sound simple, but the reality is, manufacturing is naturally complex, and in life sciences, even moreso. At any given site, you have to determine exactly the right amount of governance depending on the use case.
This complexity and specificity is the exact reason for composability.
Life sciences is built on continuous improvement. In fact, that’s why the vertical exists. Manufacturers can understand, then, that there’s no need to boil the ocean. We improve incrementally — sometimes with leaps and bounds, but by and large, with steps and iteration.
Importantly, improving in this way allows you to tease out the interdependencies and limitations of each use case or need within the operation, so you can make better decisions about how to connect their data structures and how to allow for information sharing even within a strict governance environment.
Use cases across pharmaceuticals and biotech, as an example, include:
Work orders to track that each batch is using the correct recipe for the correct customer
Line clearance to prevent cross-contamination
Weigh and dispense applications to ensure the correct amount of each ingredient is weighed
Digital work instructions that use media-rich (videos, images, etc) instructions to clearly show next steps and improve quality
Quality data collection that automatically writes and stores data such as batch information, time of completion, e-signatures, etc. and reduce risk of human error
Shipping applications to automatically create shipping labels and ensure products are delivered to the right customers
As these applications demonstrate, composability (and the architecture that allows for it) gives life sciences manufacturers a new opportunity to upgrade quality and quality assurance continually.
That’s the same ethos life sciences are built on, and the ability to live it out on the floor is a rare gift in such a well-regulated vertical.
Read the next post in this series to learn more about how Tulip is challenging traditional MES with a platform approach built for composable business.