|This enhanced e-book describes the
changing regulatory landscape and
what life science companies can
expect in the future.
Editor, MasterControl Insider
Which came first, the chicken or the egg? This dilemma applies to automation and regulatory compliance. Did the FDA issue 21 CFR Part 11 to encourage technology use? Or did life science companies use technology first—prompting the FDA to develop corresponding regulations?
The chicken-or-egg riddle may never be answered, but a new book, “Convergence of Compliance and Technology,” traces key developments in the past 15 years that revolutionized regulatory compliance for the life science industry.
Scientific breakthroughs—such as a drug that treats cystic fibrosis and a brain sensor to help paralyzed patients control assistive devices with their thoughts—are possible only with the help of faster and more efficient, technology-driven clinical trials, regulatory submissions, and approval process (1).
The book’s author, Matthew M. Lowe, uses the highway as a metaphor for the relationship among life science companies, technology providers, and regulators. “If our society were a city, then writing this book is a chance for me to offer you a snapshot of the highway where life science and technology merge in order to deliver medical solutions to the rest of the world. That on-ramp where the two merge is regulatory compliance,” he writes. “Without compliance, there can be no product approval, which means no matter how cutting-edge your device or how innovative your medicine, it will not reach the people who need them.”
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Stories, Milestones, and Insights
Lowe, executive vice president at MasterControl, is a mechanical engineer with over 15 years of medical device experience in product development, product management, and regulatory compliance.
He combines a discussion of key regulations relevant to the life science industry with his observations and experiences. He recalls the cumbersome manual process he endured as a product development engineer at a med device firm.
“We used to have great filing cabinets with very long drawers. The Engineering, Purchasing, and Manufacturing Departments each maintained its filing cabinet. For Engineering, we kept a controlled copy there with little labels. The person who needed a document would thumb through all fifty drawings and look for the right document, if it was there at all,” he writes.
Lowe describes how the advent of 21 CFR Part 11 affected his and his team’s work. “I have to admit that back when I worked in an R&D Department of a med tech company, my colleagues and I were not familiar with Part 11. The first time I heard about it, I learned we were required to validate software as part of our testing regimen. Validation is something we dealt with all the time in manufacturing and design, but with the introduction of Part 11, there was an added requirement of software validation.”
Sounds familiar? If you belong to the life science industry, you will relate to Lowe’s anecdotes. Compare your “battlefield” stories with his and see how things have progressed over the years. Find out what regulatory compliance might look like in the future.
“Convergence of Compliance and Technology: How Technology Has Changed Regulatory Compliance in the Past Decade,” published by MasterControl, is an enhanced electronic book that includes illustrations and a video. It covers the following:
- The Old Manual Process: “Battlefield” stories and the pains of a typical paper-based process.
- The Movement toward Automation: How 21 CFR Part 11 came about and became a big deal.
- Important Milestones: 16 laws and initiatives helped spur technology use in regulatory compliance for the life science industry.
- No Time Like the Present: How life science companies and tech providers are adapting at present.
- The Future Starts Now: There will be more and more technology-driven regulations in the future and they will require “smarter compliance.” The author offers his insights on how to achieve it.
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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) The book referred to Kalydeco for the treatment of cystic fibrosis in patients age 6 years and older who have the specific G551D mutation in the cystic fibrosis transmembrane regulator (CFTR) gene. The book also referred to the BrainGate2 Neural Interface System, currently in clinical trial, which is essentially technology-driven telekinesis for paralyzed patients.