Insights

A Partner in 21 CFR Part 11 Compliance

Posted on Jun 12, 2017 10:59:35 AM

How the right partner can smooth the path to a fully compliant regulatory and document management system

Efforts to transition to a streamlined paperless operation are unquestionably worthwhile. But the characteristic increases in efficiency are of little value if the transformed organization falls short of 21 CFR Part 11 compliance. That is why it is critically important that every step on the path to the paperless transformation is guided by professionals who are deeply, intimately familiar with the requirements for compliance.

Dustin Caldwell, director of operations for OptiMed Research, and Neal Surasky, data manager and quality assurance coordinator for the Chesapeake Research Group (CSR), have completed the journey to paperless transformation, accompanied along the way by Complion in order to ensure that the process stayed on track to achieve 21 CFR Part 11 compliance -- even when staff at the OptiMed and CSR lacked experience with and understanding of compliance requirements.

“Everything it does is 21 CFR 11 compliant,” he says. “The system is designed so that regardless of staff understanding, they’re being compliant anyway. It has to be that way,” states Neal. In addition, any vendor can claim their system is Part 11 compliant, but how do you really know? That is what the validation process is for.

“Validation is a way for us to show whomever -- whether it's somebody in our company or somebody who is monitoring for a CRO or sponsor -- that our claims that our claims to Part 11 compliance are valid.” He continues to explain that, “during the validation [process], we’ll go through each item and it will illustrate for us that the system does what it claims to do. It's all documented and verifiable.”

Dustin’s experience is similar to Neal’s. But Dustin observes that understanding of 21 CFR Part 11 correlates more to responsibilities within a site. “Our operations are very compartmentalized,” Dustin says. “We have one person that is just our regulatory and compliance officer. We have another person who does operations,” and related activities.

When first approached by Complion, Dustin didn’t handle regulatory. “I had this vague notion of how compliance worked as far as what the industry would and would not accept. I think that was the stumbling block for us,” Dustin admits. ”But once you go through the training and you’re exposed to the software and the system and the way it works, it all becomes very intuitive, and it’s something that you just accept at face value. it’s all part of living compliant.”

For a closer look at Neal and Dustin's journey to Part 11 compliance, hear how they cleared up common misconceptions and how they eventually came to understand and implement validation processes at their respective sites.


Complion’s team of certified research professionals has developed deep expertise in 21 CFR Part 11 regulations. Not only is our platform Part 11 compliant, we will partner with you to do everything required for compliance, including validation, training and process development.

To learn more about 21 Part 11, check out these related resources:

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Topics: Paperless Clinical Trials, Compliance, Regulatory Compliance, 21 CFR Part 11


Abbie Hosta

Written by Abbie Hosta

Educational Outreach at Complion, a SaaS platform that is transforming the way clinical trial site documentation is created and maintained. Passionate about technology, education, and helping others work more effectively.