Ensuring Compliance With Part 11: A Site's Perspective

Today’s clinical research sites are under tremendous pressure to produce more in an increasingly complex environment; however, the sophistication of sites’ information technology (IT) systems often remains antiquated, lagging those used by the healthcare organizations with which they work. Office bookshelves bursting with paper binders function better as cubicle walls than workable repositories. Manual processes limit credentialed staff from realizing potential, and siloed systems and departments prevent productive collaboration.

As more sites are looking to implement technology to go paperless, improve standardization, and provide secure access to essential documents, site staff ’s experience with ensuring compliance with 21 CFR 11 (Part 11) of the Code of Federal Regulations—focusing on the U.S. Food and Drug Administration’s (FDA’s) standards for electronic records and electronic signatures — may be limited. Balancing the need to maximize efficiency and ensure compliance presents a challenge, but with the right resources, the challenge is an achievable one. Gaining a better understanding of the purpose, scope, and components of Part 11 will help sites achieve their compliance goals.