How to fill the digital void in pharma manufacturing
Discover how digitizing batch records in pharma manufacturing can reduce risk, improve data integrity and streamline processes
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Modern manufacturing technology such as automation and advanced analytics holds promise for greater process efficiency and product quality. Ahead of the Pharma Manufacturing Automation online event, taking place on 18-19 May 2021, Pharma IQ spoke with Brian Curran, Senior Vice President Customer Success for Manufacturing Excellence, and Jennifer Hurst, Marketing and Communications Executive, both at MasterControl. They discuss how those with an appetite for technology can best digitize batch manufacturing records to gain business benefits.
Pharma IQ: What are some of the most significant drivers of moving to digital for pharma manufacturers?
Brian Curran: Pharma manufacturers have very similar drivers for moving to digital than other industries, including time-to-market and increasing competitive pressures. However, one of the drivers that really sticks out like a sore thumb in pharma manufacturing is moving away from paper. While pharma manufacturers are increasingly automating their operations to improve their processes, their batch records are still paper-based. If paper processes were digitized pharma companies would be able to get to market much faster.
Jennifer Hurst: With respect to the Covid-19 pandemic, and not to beat this topic to death, a lot of pharma manufacturers were forced into remote-working environments and realized there were gaps in their digital processes. As Brian has pointed out, paper is one of the major hurdles for the industry and the pandemic has placed a lot of emphasis on pharma’s digital gaps. This is because you no longer had people to pass around paper documents or sign them, which meant the manufacturing process became very stifled and delayed.
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Pharma IQ: How can manufacturing automation further enhance pharma’s data capabilities and centralize data going forward?
BC: In my opinion, pharma manufacturers have achieved great pockets of fantastic automation – the key word here being pockets of automation, with extensive data capabilities. However, as I mentioned before, the majority of manufacturing sites and lines today still use paper-based batch records, and other paper-based or siloed spreadsheet data systems. By adopting newer automation technologies, such as cloud-based software systems that can be implemented and deployed in 30 to 60 days instead of one to two years, pharma manufacturers can further enhance their data capabilities, and save time and money.
Pharma IQ: A Pharma IQ survey highlighted 65 percent of pharma companies who responded believe increasing the industry’s use of technology to sustain customer demand and collect and analyze data in real-time is critical to mitigating the long-term impact of the Covid-19 crisis. What are your thoughts on this and are you currently seeing any evidence of increased technology use in the manufacturing space since the onset of the Covid-19 pandemic?
BC: What is interesting about the pharma market today is that changes in demand can happen in a blink of an eye. I agree that going digital with an adaptable and configurable system enables pharma manufacturers to stay consistent in demand production, whether that is in the event of another Covid-19 wave or keeping up with new industry trends.
As an industry, we have become so accustomed to having people on site to do the essential work. Even though we are seeing islands of automation happen, pharma manufacturers are still highly dependent on people performing jobs on the lines who upkeep the paper-based batch records. With the Covid-19 pandemic, all of a sudden, people are not able to go on site and pharma manufacturers no longer receive the same visibility, so we have begun to see an uptick in demand to digitize records to overcome this.
JH: The US Food and Drug Administration has announced it will be doing remote inspections of manufacturing sites following the restrictions of the Covid-19 pandemic. We are seeing increased uses of technology within manufacturing operations and auditing to make processes both more efficient and timely.
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Pharma IQ: How is MasterControl championing pharma’s progress to digital?
BC: One of the biggest challenges we have as a company is generating awareness. We have had to do some myth busting around electronic batch record projects as these schemes in the past proved to be extremely costly and would usually fail. Now, we are trying to educate the industry on newer technologies available on the market that can be implemented quickly and at a fraction of the cost.
Secondly, we are also helping the industry understand that yes, there is an extensive amount of automation and digital capabilities already on every shop floor, but they are overlooking that main thread that connects it all together, digitizing their batch records.
JH: We are seeing a huge trend toward personalized medicine in the pharma market. When you get into it, you are dealing with smaller batches and the industry is yearning and demanding for a new solution to ensure keeping up with this demand. At MasterControl, we are devoting resources to create a product that fills this void. As Brian has pointed out, we have to go into myth-busting mode to ensure the industry knows these resources are out there to help them.
Pharma IQ: What are some of the key insights attendees can expect from your session at Pharma Manufacturing Automation?
BC: Our session will be relevant for everyone, regardless of where attendees are at in their paperless or digitization journey. We will be highlighting how pharma manufacturers can gain business benefits by using advanced capabilities, leveraging data and reducing the total number of complaints by improving the overall manufacturing process. We will uncover how to move into more of a predictive, recommended approach to get manufacturing batches done more quickly. I look forward to welcoming all the attendees to our session.
To access the full range of insights and advice from MasterControl, sign up for Pharma Manufacturing Automation.
