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’s why it’s critical every step to paperless transformation is guided by professionals who are skilled in 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 (CRG) completed the journey to paperless transformation accompanied by Complion. The staff at OptiMed and CRG lacked experience with and understanding of compliance requirements.
“The Complion system is designed so that regardless of staff understanding, they’re being compliant anyway,” Surasky says.
Most eRegulatory vendors make claim to prospective clients 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 to be Part 11 compliant are valid,” Surasky explains. “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.”
Caldwell’s experience is similar to Surasky’s, but he feels understanding 21 CFR Part 11 correlates more to responsibilities within a site. “Our operations are very compartmentalized,” he says. “We have one person that is just our regulatory and compliance officer and another person who does operations and related activities.”
When first approached by Complion, Caldwell 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,” he 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. It’s something that you just accept at face value. It’s all part of living compliant.”
For a closer look at CRG’s journey to Part 11 compliance, get your copy of “A Research Site’s FDA Inspection with eRegulatory.”
Complion’s team has developed deep expertise in 21 CFR Part 11 regulations. We’re ready to partner with you to do everything required for compliance, including validation, training and process development. Learn more.