As a new wave of digital technologies – from cloud and big data to advanced automation and blockchain – promise to transform your business, how do you remaster your quality and compliance processes for the digital era? A new Executive Brief, “The War on Paper: A Corrective Action Plan for Going Paperless” — the first in our Quality ReMastered Series — highlights the need to let go of paper-based processes that inhibit innovation and increase your risk profile.
In a New York Times article, Dr. Amy Abernethy at Flatiron Health, a subsidiary of Roche, is quoted as saying, “About 50 percent, 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.”
And it’s not just running clinical trials. What if you 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 describes his time at the U.S. Food and Drug Administration (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 & COO of Wellington Foods, 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.”
Moving to a fully digital, software-based environment for your data, documentation, signatures and communications breaks down silos, drives efficiencies and improves levels of quality and control.
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.”
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.
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.
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 insights and perspective, download our Executive Brief, "The War on Paper: A Corrective Action Plan for Going Paperless".
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