|21 CFR Part 11 is one of the FDA
regulations and initiatives that
helped modernize compliance
for life science companies.
Not too long ago, regulatory compliance meant color-coded stamps for various documents, gigantic cabinets for storing files, and truckloads of paper documents for FDA submissions. The advent of 21 CFR Part 11 signaled the movement toward automation. It’s one of 16 regulations and initiatives that helped modernize the compliance process for life science companies.
In his first job as a product development engineer at a medical device firm, the change control process for getting a new drawing through the system resembled an obstacle course that required a lot of time, effort, and patience. The simple act of document submission was anything but simple.
“Imagine standing before a long table with an array of stamps and different colors of ink pads with your piles of documents. Perhaps you would need a blue stamp for ‘proposed’ documents, a green stamp for ‘approved’ and black for ‘released.’ Talk about watermarking! You would stamp each copy with the appropriate stamp. You would then attach your documents to the CO [change order] form and submit everything to doc control, cross your fingers, and hope you didn’t miss anything,” he writes. “If doc control took issue with anything, it would involve re-printing documents, revisiting the table for re-stamping, and re-submitting the change packet.”
The book traces the major developments that transformed the compliance process in the past decade.
Compliance and Automation
R&D has always been associated with technological advances, but not regulatory compliance. The cumbersome manual processes eventually compelled many life science companies to automate their quality systems, either partly or entirely. In the early 1990s, a group of pharmaceutical companies asked the FDA how they could submit voluminous documents electronically. In due course, this led to the development of 21 CFR Part 11 (1).
The pivotal regulation went into effect in August 1997, but it took the FDA two guidances to explain its scope and application. Automation in compliance and submissions began in earnest after the second Part 11 guidance was issued in 2003.
“Part 11 confirmed the dire need for improvement of labor-intensive processes and justified corporate spending on electronic systems. It showed executives of life science and other regulated companies that investing in automation was a wise option,” says Lowe.
The Heart of Part 11
21 CFR Part 11 established the criteria for the use of electronic records and electronic signatures by organizations under the jurisdiction of the FDA. Its goal is to allow the use of electronic records as much as possible and at the same time ensure public safety. FDA’s main concern is whether all electronic records in support of regulated activities are accurate and valid.
Industry members believed that the FDA considered the risks of falsification and misinterpretation are higher with electronic records than paper records and therefore required specific controls under Part 11.
“I would add that on top of those concerns, both the FDA and the industry wanted to reduce the tremendous time and effort, plus the high cost involved in regulatory submissions and compliance,” says Lowe, MasterControl executive vice president.
In the enhanced e-book, “Convergence of Compliance and Technology: How Technology Has Changed Regulatory Compliance in the Past Decade,” Lowe identifies 16 regulations and milestones that called for technology use and helped modernize regulatory compliance.
“Since 2000, we have benefited from a technology-driven era in regulatory compliance. Ours is a time of faster and more effective regulatory submissions and adverse-event reporting. I would like to think that things will get even more efficient in the future,” says Lowe.
These are some of the important initiatives in the past three years:
2013: The FDA released a final rule establishing a unique device identification (UDI) system that will identify medical devices through distribution and use.
2014: The FDA required device manufacturers and importers to submit mandatory reports of adverse events electronically (known as eMDR).
2014: The FDA’s 510(k) eSubmissions Pilot Program (called “turbo 510(k)”) offers a pathway for the construction and submission of a pre-market notification application electronically.
2015: The FDA finalized its guidance that required most eCTD submissions to be submitted electronically.
2015: The FDA’s Adverse Reporting System/MedWatch required that applicants electronically submit all MDRs, MDR attachments, and periodic safety reports.
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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.