A lot of work is being invested to ensure research site audit readiness, oversight, and completeness of regulatory files or binders. Unfortunately, there is a lack of understanding if everything is being done to the level of completeness, accuracy and quality that is required. As a result, site regulatory can be a real challenge for Sponsors and CROs.
This Complion question and answer session held with Dr. Harvey Arbit, an adjunct professor at the University of Minnesota College of Pharmacy, provides insights into achieving stress-free FDA inspections.
The characteristic increases in efficiency as a result of transitioning to a streamlined paperless operation are of little value if the transformed organization fails to be 21 CFR Part 11 compliant. It’s critical every step to paperless transformation is guided by professionals who are skilled in the requirements for compliance.
As a research coordinator or administrator, being buried under a mountain of paper files is not something that has to happen often before it becomes apparent there must be a better way. That better way is an eRegulatory system.