Successful Part 11 Compliance in a Universe of Electronic Data

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Stringent regulations exist to govern how to handle research data in electronic form. In the United States, 21 CFR Part 11 is the chief such regulation. It requires that systems ensure electronic records are attributable, original, accurate, contemporaneous, and legible. It also ensures that investigator maintain access to and control of records, meaning that a good record archiving capability is essential. During this webinar, we will:

• Review the basics of Part 11 and related regulations.
• Examine what data and systems are within the scope of Part 11 and which are tangential.
• Discuss how both good tools and good processes are necessary to succeed in a Part 11-compliant environment.
• Briefly explore the changing landscape of electronic data in healthcare, and what it means for research.

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