This year holds the promise of everyone receiving a vaccine for COVID-19. Contract pharmaceutical manufacturers are at the heart of these efforts, and skyrocketing demand requires the industry to move even faster than before. There couldn’t be a more important time to evaluate manufacturing processes and eliminate anything causing unnecessary delays, and there are five key reasons why the first thing to go should be paper on the shop floor.

1. During a labor shortage, pushing paper costs time nobody can afford
An urgent need for COVID-19 vaccines and treatments has created a considerable labor shortage within the contract manufacturing industry.

The Wall Street Journal recently reported an estimated six billion doses of COVID-19 vaccines will be produced in 2021. The major pharmaceutical companies with a vaccine candidate are relying on contract manufacturers to help with production. The strain on resources is apparent as the world’s 10 largest companies that won COVID-19 outsourcing work have more than 5,000 job openings, and it’s a struggle to fill everything from specialized roles to overnight shifts.

Under these circumstances, it’s imperative that shop floor workers make valuable use of their time, and paper-based manufacturing processes are slowing them down.

Case in point, I remember visiting the shop floor of a medical device company in the UK. My first impression was positive because they appeared to have an efficient process in place for their paper batch records. Later, when we crunched some numbers, they revealed a very different picture.

We estimated the operators spent about three hours per week completing paperwork, and that didn’t include review time. Three hours sounds fairly benign, but with more than 450 employees, the hours they spent pushing paper each week is the equivalent of 30 full-time employees. Consider how much can be accomplished by 30 employees.

When the industry is scrambling to find workers to produce a life-saving vaccine needed around the globe, it doesn’t make sense to use paper-based processes. Eliminate them and adopt a digital solution to boost efficiency at a time when it’s needed most.

2. Unlike paper, a digital solution provides actionable insights
To elaborate on my first point, paper-based processes are incredibly time consuming and digitization streamlines these efforts. For example, the life sciences industry accumulates a lot of information, and managers generally try and use it to help guide business decisions. When this information is spread across multiple documents that are saved in different locations, gathering the right data becomes a logistical nightmare.

Research conducted by Vanson Bourne showed that on average:

• Eight hours per week are lost searching for, acquiring, entering or moving data around;
• IT decision-makers spend five hours connecting, integrating or maintaining data. They spend that same amount of time on new, more strategic initiatives; and
• Business users in the U.S. spend more than 35 minutes per day moving data from one system to another.

A digital system is connected and stores data in one location. The information you collect, like everything entered into an electronic batch record, is data you can analyze to gain insights into business performance. This makes it possible for executives and managers to make data-driven decisions that are proactive rather than reactive—and even predictive.

Ultimately, having the right data helps you to accomplish more with less. Time is at a premium right now, which makes digitization an ideal way to maximize productivity and keep pace with the industry.

3. It’s essential to scale quickly, and that’s impossible to do with paper
Paper simply can’t scale at the same rate as demand for contract pharmaceutical manufacturing, which means companies using paper-based processes are being slowed down in an industry that is only picking up speed.

Manufacturing COVID-19 vaccines is an urgent priority today and the needs that existed prior to the pandemic still require attention. Contract manufacturers are scaling up for the high-volume manufacturing necessary for vaccine production, but they need to remain flexible to compete in emerging markets. In 2019, a quarter of new drugs approved by the FDA were personalized medicines, presenting lucrative opportunities within contract pharmaceutical manufacturing. Companies that can scale quickly are positioned to benefit the most.

“Products for small patient groups create a different set of manufacturing demands and business models, with shorter runs and facilities and operations that must go patient to vein in short order. CDMOs are learning to accommodate these new demands and they create opportunities for nimble, well-run manufacturers,” explained Gil Roth, President and Founder of the Pharma & Biopharma Outsourcing Association.

This type of scalability is only possible through digitization, which makes digitization key to taking advantage of the opportunities created by the surge in demand for contract manufacturers.

4. Companies relying on paper risk falling behind, but they can get ahead with new technology
In a world that is increasingly dependent on technology, businesses that don’t adapt risk becoming obsolete.

A classic example of this is Blockbuster. The chain of video rental stores was enormously popular, but then Netflix emerged with a completely new business model, and while they explored ways to make the video rental experience entirely digital, Blockbuster held tightly to their brick and mortar stores. In 2008 their CEO declared, “Neither RedBox nor Netflix are even on the radar in terms of competition,” and just two years later, Blockbuster filed for bankruptcy. Meanwhile, Netflix continues to challenge other entertainment giants, and their value recently surpassed that of Disney.

Blockbuster’s inability to adapt to new technology spelled the end for a business that once dominated an industry, and an early toe hold in the demand for digital services is what skyrocketed Netflix to success.

Today, digitization is an opportunity for contract pharmaceutical manufacturers to streamline business operations and thrive in a constantly changing industry. Those who adopt new technology will quickly surpass companies who insist that paper worked back then and still works today.

A recent article published by McKinsey & Company noted the many ways digitization positions a company to remain ahead of their competition. They reported, “Through digital transformation, manufacturers have seen significant improvements including less machine downtime, an increase in employee productivity, increased throughput, and decreases in the cost of quality.”

In time, paper processes will be antiquated and organizations that were slow to adopt new technology will struggle to keep up with their competitors who digitized today.

5. It’s essential to get to market quickly, and paper can slow you down
When it comes to getting COVID-19 vaccines ready, speed is imperative. In a paper-based manufacturing environment, human errors made throughout the production cycle can accumulate and result in delays that take days or even weeks to fix.

Someone on the shop floor might write down the wrong number on a batch record. Later, that batch record is reviewed as part of the post-production process, which means someone has to track down the right information and correct the batch record. Throughout the process, finished product sits waiting to ship. And unfortunately, this happens pretty often.

A company I worked with had a 20% first pass approval rate, which means 80% of the time, additional follow-up was needed before a batch record was complete and ready to ship. That’s not ideal, and the majority of these common data input errors are avoidable.

Digitization makes it possible to ensure data is entered right the first time, which shortens documentation review cycles. In one instance, a contract pharmaceutical manufacturer of nutraceuticals had post-production reviews that were taking as long as two weeks. The company adopted a digital solution and decreased data entry errors by over 90%. Having the right technology shortened review time to just three days.

As another example, a contract pharmaceutical packaging company with more than 200 batch records spent up to three hours reviewing each one. The company did a trial run with a digital solution, and the amount of time spent on quality reviews was reduced to 15-20 minutes per batch record. To put it another way, if you add up the person-hours, the company went from spending the equivalent of two months on batch record reviews to completing a review of the same information in less than two weeks.

Doing away with paper-based processes and digitizing saves time by making sure most mistakes are corrected in real-time. Then it’s possible to conduct a review by exception, and it’s only necessary to look at exceptions that occurred during the production run. The end result is eliminating avoidable delays, being more productive with the hours available in a workday, and getting quality products to market faster.

In conclusion, paper hinders almost every aspect of manufacturing processes and needs to be eliminated from the shop floor. Digitization allows workers to spend time on value-added activities and makes it possible to collect data to make informed business decisions that are proactive and ultimately provide a competitive edge. The right manufacturing solution helps a company maintain that lead by making it possible to scale rapidly and adapt to ever-changing market conditions. These advantages all result in maintaining high quality standards while manufacturing batches without any of the delays caused by paper. 

References

1. “Covid-19 Vaccines Are in High Demand, but Thousands More Workers Are Needed to Make Them,” Elizabeth Koh, Wall Street Journal, January 4, 2021.
2. “The High Cost of Disconnected Data,” SnapLogic, 2017
3. “The Personalized Medicine Report,” Personalized Medicine Coalition, 2020.
4. “Keynote: The Future of Drug Manufacturing,” Dong Soo Kang and Gil Roth, CPhI festival of pharma®, October 5-16, 2020.
5. “The Rise and Fall of Blockbuster and How It’s Surviving With Just One Store Left,” Andy Ash, Business Insider, August 12, 2020.
6. “13 Quotes From Bosses Who Mocked Technology and Got It (Very) Wrong,” Grahm Rapier, Inc.
7. “Why Netflix Is Worth More Than Disney,” Dana Blankenhorn, InvestorPlace, November 6, 2020
8. “Preparing for the next normal via digital manufacturing’s scaling potential,” Enno de Boer, Søren Fritzen, Rehana Khanam, and Frédéric Lefort, McKinsey & Company, Apr. 10, 2020.

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Dave Edwards brings more than two decades of sales, manufacturing, customer service, and general business management experience to MasterControl, a leading global provider of software solutions that enable life science and other regulated companies to deliver life-changing products to more people sooner. Edwards most recently served as the chief operating officer at 3form, a leading manufacturer of translucent building materials in the architecture and design industry. Prior to 3form, he worked at Danaher Corp., a Fortune 500 manufacturing conglomerate, and at TenFold Corp., an enterprise software company. Edwards holds an MBA from Harvard Business School and a bachelor’s degree in economics from the University of Utah.