GxP Lifeline
Manufacturers See Sizable Gains in the Leap From Paper to Digital Data
As life sciences companies get ready to turn the page on 2019, a manufacturing sector transformation that started gradually but is increasingly trending globally is what MasterControl dubbed the War on Paper earlier this year. More and more, companies are “seeing the light” of the glow of digital dashboards and tablets emitting from competitors’ shop floors, and recognizing that manual, paper-based data processes simply don’t cut it in 21st-century manufacturing.
A quantum leap of technological advances in the last decade with direct implications for manufacturing — such as blockchain, artificial intelligence and the digital connectivity offered by the internet of things (IoT) — means maintaining the status quo of paper-based data processes is unsustainable.
Why Not Paper?
In a New York Times article, Dr. Amy Abernethy, then with Flatiron Health, a subsidiary of Roche, and currently principal deputy commissioner of food and drugs for the U.S. Food and Drug Administration (FDA), said, “About 50%, if not more, of the critical details we need for research are trapped in unstructured documents … They are in PDFs. Maybe a doctor put in a note by hand, maybe a doctor typed it. That note became a narrative. It is not something that can easily be put into a spreadsheet.” (1)
And it’s not just running clinical trials. What if you electronically design and manage processes essential to regulatory, supplier and manufacturing operations? How does a reliance on paper or hybrid solutions using Microsoft Word and Excel slow you down?
Recently, Bryant Headley described his time at the FDA when he pushed to implement electronic document, training, audit and process modules because, as he put it, “Continuing to rely on antiquated, paper-based document control can lead to obscured data-driven insights, endless opportunity for human error, and harmful blind spots across organizations.”
As Tony Harnack, president and COO of Wellington Foods, a nutritional supplements manufacturer, explains, “At the heart of regulation is process control. It requires the companies in our industry demonstrate the ability to control their process in a very robust way. But as we've grown, and the volume of transactions has increased, the paper-based systems become harder and harder to manage.” Switching to a digital, connected system, he points out, “gives us real-time data and a better management feel for what’s happening on the shop floor. It allows us to create management dashboards so that we can understand what’s happening in products … Speed to market is a big driver for us, if we can cut a day or two out of that documentation control and review process, that’s a big deal.”
Digital Drives Data Efficiencies
Moving to a fully digital, cloud-based solution for your data, documentation, signatures and communications breaks down silos, drives efficiencies and improves levels of quality and control. More specifically, manufacturing production records, whether in the form of batch records, device history records, travelers, etc., when automated through an electronic solution, put accurate, complete production data at the fingertips of shop floor managers and personnel in real time. This means a manufacturer can check data flows during production to avoid many of the costly, time-consuming inefficiencies created when bad data results in deviations, delays and downtime on the shop floor.
A recent McKinsey report cites use cases for digitization and automation in pharma manufacturing labs that demonstrate “More than 65 percent reduction in deviations and over 90 percent faster closer times. Prevention of major compliance issues can in itself be worth millions in cost savings.”(2)
If the benefits are so obvious, what’s holding organizations back? Recent data demonstrates that digital initiatives often lack funding or are poorly adopted as quality leaders struggle to clearly define the business case. This gets combined with a mindset in highly-regulated, process-driven environments that’s averse to change.
One way forward: focus on piloting a few projects to prove success and overcome any unfounded fears. For example, several manufacturing companies that recently participated in a pilot program for a digital production records solution reported significant efficiencies, decreases in production errors, and considerable time savings by ditching paper and automating their production records process.(2) Wellington Foods saw a 90-100% decrease in data entry and input errors while Legacy Pharmaceutical Packaging witnessed a 20-25% reduction in total deviations. Perhaps most notably, Wellington Foods reduced its post-production review times “from 10-15 days down to three days — a 75-80% reduction.”
Conclusion
You can start your digitization efforts with an approach called “small automation,” which focuses on fast implementation of flexible and adaptable technologies to fill the gaps left by current enterprise systems. Many of these small automation solutions can be integrated with your existing manufacturing systems and provide shop floors with the connectivity and access to real-time data that can be a game-changer in terms of production error reduction and time-saving efficiencies.
Ultimately, it can be these smaller, faster approaches to replacing paper-based and hybrid processes that will help deliver greater time-to-value, while easing the barriers that make people resistant to change.
For additional insight and perspective, download the executive brief, “The War on Paper: A Corrective Action Plan for Going Paperless.”
References
- “New Cancer Treatments Lie Hidden Under Mountains of Paperwork” by Gina Kolata. New York Times. May 21, 2018. https://www.nytimes.com/2018/05/21/health/medical-records-cancer.html
- “Digitization, automation, and online testing: The future of pharma quality control” by Han, Makarova, Ringel and Telpis. McKinsey & Company. January 2019. https://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/digitization-automation-and-online-testing-the-future-of-pharma-quality-control
- “Metrics That Matter for Quality Manufacturing” customer spotlight. MasterControl. 2019.
Mike Rigert is a content marketing specialist at MasterControl’s headquarters in Salt Lake City, Utah. A native of the Chicago area, he has nearly a decade and a half of experience creating journalism and marketing content for the news media, public safety and higher education. He has a bachelor’s degree in political science from Brigham Young University.
