Article | June 8, 2021

Regulatory Fine Points: What Research Sites Need To Do For Part 11 Compliance

Source: Advarra

By Meghan Hosely

Bulb-regulation-compliance

At Advarra, we strive to provide sponsors, contract research organizations (CROs), and sites with the knowledge they need to perform adequate quality management as they work to advance safer, smarter, and faster research. Similarly, the Society of Quality Assurance (SQA)’s mission statement indicates the organization aims to “Promote and advance the ethics, principles, and knowledge of quality assurance essential to human, animal, and environmental health.”

Last month, at SQA’s annual meeting, Advarra’s VP of Research Services and Strategic Consulting, James Riddle presented Regulatory Fine Points: What Research Sites Need to Do for Part 11 Compliance. In his presentation, Riddle outlined how sponsors should consider 21 CFR Part 11 (Part 11) compliance at research sites and how that fits in with the overall quality management system they may administer, build, audit, or evaluate.

As the research industry is continually evolving and adapting, many institutions, health systems, and private research sites are adopting more electronic technologies to streamline operations. While oftentimes, sponsors or CROs provide sites with validated technology, many adopt these technologies themselves. For quality management professionals and site regulatory personnel in the position to evaluate a system’s effectiveness, quality, and compliance, they need to understand how Part 11 compliance fits into the quality management framework.

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