Data-driven manufacturing models that offer flexibility are emerging to address the pharmaceutical industry’s need for greater operational efficiency.
Although new approaches aim to solve the unique challenges of the sector, such as adhering to strict compliance regulations, digitalisation has quickly developed into a pathway for IT/OT integration, edge-to-enterprise connectivity and overall operational excellence.
A recent report from the IDC, based on extensive research in pharmaceutical manufacturing, highlights this need while exploring the drivers that are encouraging innovation both now and in the future.1
The report states that although objectives vary, the common factor in all innovation journeys is the importance of data integrity. In the pharmaceutical manufacturing industry, data integrity refers to the state when data is attributable, legible, contemporaneous, original, accurate, complete, ensuring and always available.
It’s not only critical for the industry to ensure that end product meets all the required quality and traceability standards, it also enables innovation and digital transformation in the sector.
Modernising manufacturing
Accelerating operational efficiency requires updated manufacturing processes; yet, the starting point of all modernisation journeys is data. Traditional manufacturing models suffer from siloed processes, rigid production environments and a lack of interoperability.
This results in the poor visibility of operations and assets, ultimately limiting potential productivity and reducing the quality of the final product. In the pharmaceutical sector, this often means that entire batches must be thrown away as soon as a manufacturing issue occurs.
This siloed approach also makes it difficult to meet traceability and compliance regulations. Combined, a lack of data visibility and integration has a negative impact on compliance, costs and company reputation. None of this should be news to the pharmaceutical sector … and there are positive signs that steps are being taken to modernise.
In 2022, improving operational efficiency has risen to the top of the business priority stack for pharma organisations worldwide, underpinning all strategic initiatives that were originally planned for that year.
Supporting the need for transformation, 35% of organisations consider innovation to be instrumental to achieving operational efficiency. Further, the digital transformation of manufacturing processes tops the list of intentions for life sciences organisation planning to boost their efficiency.
Now, although these statistics point towards an industry that is tackling transformational change head-on, 50% of those surveyed assess their maturity regarding smart operations as either “not yet started” or at an “early stage of planning.” In summary, we have a sector that knows it needs change and why, but doesn’t know how to get started.
Transformation without a purpose is not innovation and throwing new technology at a problem without strategic forethought won’t achieve the desired result.
For pharmaceutical manufacturers to make meaningful advancements in digital transformation and reach the level of operational efficiency needed, they must address where their computing actually happens and make use of edge computing.
Edge computing is deployed at the source of data, right at machine level. It collects and processes data from sensors on machines that, in a compliance-heavy sector, are often already in place. Where data at this level is not being collected, in the age of IIoT, sensors are relatively inexpensive to fit.
The great strength of edge computing is that it can take this raw data and process it at source, reducing the latency involved in sending it to a data centre or into the cloud, and opening up the world of real-time actionable intelligence that can drive continuous improvement.
In pharmaceutical manufacturing, this can mean the difference between resolving an issue and continuing production versus losing entire batches to avoidable production issues. This real-time data analysis is also a foundation stone that will lead to many other potential benefits of digital transformation — such as the use of artificial intelligence to “see” further improvements and predictive maintenance.
Meeting compliance requires innovation
The recent IDC survey also shows that concerns about regulatory compliance is among the top priorities for technology innovation for pharma organisations. Innovations in the pharmaceutical industry therefore need to meet stringent standards from the moment they are introduced.
In a heavily regulated industry, in which proving compliance often means getting regulatory approval for any changes to manufacturing, any substantive changes have an element of risk. Every process in pharmaceutical production requires some form of validation: prospective, concurrent, retrospective or revalidation.
With all these protocols complete, it can be clearly shown that each product is manufactured in exactly the same way, every time, and a safe medicine is being made for the end user. The challenge this creates is that once a process is validated, it can’t easily be changed to accommodate digital transformation and achieve greater efficiency benefits without further validation.
The opportunity for manufacturers to streamline this process lies at the edge of the network with real-time onsite data analysis. Without adequate IT infrastructure, these validation processes become a time-consuming manual process and open up the potential for human error.
The right edge computing platform quickly filters and processes the necessary data for validation protocols, freeing the IT infrastructure from a big data strain … and releasing the human operator from a time-consuming task.
The real-time data analysis made possible through edge computing also provides rapid and informed decision making for onsite operators. If, for example, an error has occurred during mixing, a temperature alarm has been triggered or a machine maintenance issue occurs, there will be a failed validation result.
By being alerted immediately, operators can take action without a need for additional IT expertise that may or may not be onsite. The right platform means that any operator can walk up to any asset and get an instant report on performance and how that relates to the ongoing validation protocols.
Breaking down silos
An operator having immediate insight into all assets is a huge step forward made possible by edge computing in pharma. Even with sufficient operational data, almost 50% of pharma organisations face prohibitive issues with silos and information quality when it comes to offering complete data visibility of all assets to operators.
This is why edge computing is so fundamental to innovation in the pharmaceutical industry. It allows data integrity principles to be incorporated into all aspects of operations. Not only does this ensure that all data meets required integrity markers, it creates the opportunity for continuous improvement.
Robust data collection and analysis lets pharmaceutical manufacturers transition from automating and supporting single discrete functionalities towards connecting production and business systems, thereby creating an edge-to-enterprise approach that offers complete visibility of operations.
By unlocking the value of real-time data, manufacturers can predict and anticipate issues before they occur, initiate actions through autonomous self-correcting systems and enable data-driven decision making.
Innovation starts at the edge
Ninety five per cent of life sciences organisations worldwide report they have more than enough operational data to achieve performance goals … but two in three of them fail to extract value from it because of issues with data accessibility, quality and fragmentation.
By deploying edge computing, pharmaceutical manufacturers can solve the issue of data integrity while laying the foundation for a unified strategy that works across the whole technology stack. This is the starting point for innovation in the pharmaceutical industry regardless of specialisation, company size or goals. For life sciences and pharma, all innovation starts at the edge.
Reference
- https://resource.stratus.com/analyst-report/innovating-pharma-at-the-edge/?_gl=1*2nuomd*_gcl_au*MTYxOTkxNDk5MS4xNjg2NjU1NDQ5.