by Cindy Fazzi
Editor, MasterControl Insider
Global health care spending is expected to increase by 4.3 percent until 2019, with biotech drug sales and medical device revenues forecasted to reach $445 billion and $454 billion, respectively, in 2019 (1). Given such growth, what kind of regulatory landscape can you expect? A newly released enhanced e-book offers five forecasts.
Matt Lowe, a mechanical engineer and medical device industry veteran, describes what the future would look like in terms of compliance for life science companies in his debut book, “Convergence of Compliance and Technology.” He also shares compelling anecdotes about the struggles of regulated companies and traces the major developments that transformed the compliance process in the past decade.
“Given the laborious manual process and the advent of Part 11, which we barely understood back then, it was easy to develop a negative attitude toward compliance,” says Lowe. “I understood the need for regulation, but often felt that I jumped through a lot of hoops just for the sake of jumping, not because those requirements made my product safer or better.”
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E-Book: Convergence of Compliance and Technology
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Compliance: 5 Forecasts
- Regulators will introduce more and more technology-facilitated standards and regulations.
- As a result, we will see greater interaction among industry, regulators, and technology vendors.
- The importance placed on software quality and validation will increase as compliance becomes more dependent on these solutions.
- Security concerns will continue to rise, both from a piracy and hacking perspective and intentional misrepresentation of data and/or users.
- Biometrics will be used more broadly in helping secure the data and quell concerns of misrepresentation.
Why You Need “Smarter Compliance”
He notes that even with the abundance of software solutions in the market today, many life science companies still fail to realize all the benefits of technology. While companies are aware of the latest technology, many fail to adopt it properly.
Matt Lowe, author of “Convergence
of Compliance and Technology,”
signed copies of his book at
the 2016 Masters Summit.
For example, even when organizations automate their quality management systems, they sometimes fail to optimize their usage because of their unwillingness to put control in the hands of those who can most effect change.
The author recommends deputizing colleagues outside of the quality department to create and execute compliance-related processes to help accelerate time to market and improve compliance simultaneously.
“I believe that in the future, we will see compliance get ‘smarter’ as technology takes a greater role,” says Lowe. “Given how fast things change in the industry, any discussion about the future implies you need to get a head start now.”
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“Convergence of Compliance and Technology: How Technology Has Changed Regulatory Compliance in the Past Decade” by Matthew M. Lowe
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SlideShare: “Convergence of Compliance and Technology”
Cindy Fazzi is the editor of MasterControl Insider, a monthly publication for MasterControl users. She writes about the life science industry and other regulated environments. Her two decades of experience as a news reporter, writer, and editor includes working for the Associated Press in Ohio and New York. She has a master’s degree in journalism from Ohio State University.
(1) Deloitte’s 2016 Global Life Sciences Outlook, page 4.