𝓤𝓷𝓲𝓽𝓮𝓭 𝓝𝓮𝔀𝓼

MasterControl is a Business Reporter client

Embracing digital automation means life science organisations can operate more efficiently, bring products to market quicker and minimise compliance risk.

Despite the obvious advantages of digitalisation, such as having immediate access to records and vastly improved efficiency, many manufacturing organisations in the life sciences sector are still hindered by manual, paper-based processes.

It’s a familiar story for Matt Lowe, Chief Strategy Officer at manufacturing execution system (MES) and quality management system (QMS) provider MasterControl. “Pretty much without fail, when I walk into a gathering of life sciences manufacturing professionals and I ask how many people still have paper-based processes on the shop floor, it’s 90 per cent of the audience,” he says. “On the quality side, it’s less so – the automation of quality assurance and quality processes in the life sciences industry is pretty mature.”

The need to address this, however, is growing. In recent months, quality and manufacturing professionals have come under increasing pressure to make more of artificial intelligence (AI), particularly from executive management.

“Everyone is talking about AI but figuring out where and how to leverage it is the real challenge,” says Lowe. “They want to know how to prepare for it and what they need to know about when operating in a regulated environment.”

Organisations’ ambitions, though, are being constrained by manual processes. “It’s pretty difficult to operate AI on top of paper,” says Lowe. “There seems to be this disconnect. We want to use all this technology that everybody’s talking about, but we’re stuck in the past.”

Taking advantage of the huge potential of such technologies is a gradual journey. Beyond the manual process, says Lowe, is a digitised system, where paper-based processes are run on digital formats. “That’s an improvement but if that’s all you do then you’ve just taken the problem and shifted it to a computerised version,” he says.

“From there, there’s what we call connected digitalisation, or true digital transformation, where you have altered your processes to take advantage of the technology. You’ve connected multiple data sources together to allow you to operate in a different way and make decisions differently than you did previously.”

The final destination is what Lowe terms an “intelligent state”, where organisations can draw on the potential of AI. “But you can’t get there without going through the other steps first,” he points out.

MasterControl’s MES and QMS solutions are designed specifically for life science manufacturers, offering the ability to adapt systems in line with changing needs. “Traditional MES solutions tend to be deployed on high-volume lines that will produce the same things in the millions for a long time,” says Lowe. “But when you have products that are highly variable and produced in relatively low quantities, they change a lot on the manufacturing line. It just doesn’t make sense to deploy a system that is very rigid, and where once it’s deployed you can’t touch it again.

“Marketplace demands are shaping the nature of manufacturing processes, especially in healthcare,” he adds. “We’re getting into the realm of personalised medicine, [such as] gene therapies, which may only be produced once for a particular patient, so it’s important to have a system that can accommodate that complexity.” MasterControl’s no-code software-as-a-service platform mean it can be configured by business users at life sciences organisations, he adds, without having to involve IT teams.

The tools allow life sciences organisations to accelerate production by eliminating paper-based processes, gain real-time insights through better data visibility and enhance collaboration by providing teams with a single source of accurate quality and manufacturing data.

The quality system means reduced compliance risk, as documentation, validation and reporting are automated to ensure adherence to ISO, FDA and other regulatory standards. One business that has benefited from this is pharmaceutical compounding firm Fagron, which implemented MasterControl’s Manufacturing Excellence system to improve consistency and reduce errors across its global locations. This led to a 50 per cent reduction in deviation times.

MasterControl has recently introduced AI tools into its products, helping customers to undertake certain tasks in workflow and processes far more efficiently, says Lowe, and to gain insight they previously did not have. An example is being able to identify calibration and maintenance requirements based on how machines are being used rather than a strict timeframe.

“It might show there’s nothing to support doing the calibration, because the machine parameters haven’t moved,” he says. “AI can see things that we as humans aren’t able to.” In future, this could extend to identifying situations that may have previously led to batches being scrapped, he adds, so organisations can stop this from happening.

Ultimately, digitalisation and greater automation mean organisations can get products to market faster at a lower cost, and do so knowing they are meeting their compliance obligations. Dietary supplement provider Wellington Foods, for instance, was able to reduce its review period for new products from ten to 15 days after production to just three – a 75 to 80 per cent improvement – while global life science firm Repligen saw its quality review time fall from four hours to one.

“Our mission is to help clients make life-changing products available to more people sooner,” says Lowe. “Digital automation means you can get more products out at a higher quality, and enhance your market reputation.”

To find out more about how MasterControl could help your life sciences organisation take control of its manufacturing and quality processes, visit www.mastercontrol.com.