eReg Binder

The Real Site Regulatory Problem

Joe Wochna eRegulatory, Regulatory Compliance, Streamlined Processes

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.

21 CFR Part 11 partner

The Right eReg Partner Smooths the Path to 21 CFR Part 11 Compliance

Joe Wochna 21 CFR Part 11, eRegulatory, Paperless Research Sites, Regulatory Compliance

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.