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21 CFR Part 11 Decoded: Definitions

In the previous two posts in this 21 CFR Part 11 Subpart A “mini-series,” we decoded Sections 11.1 – Scope and 11.2 – Implementation. It’s time to 21-cfr-part-11-definitionswrap up this mini-series with Section 11.3 – Definitions. Make sure no one is looking and then grab your decoder rings!

In the table below, the actual language from each regulation is on the left, and my personal interpretation of what that language means is on the right. Keep in mind that I do not represent the FDA and nothing in the “Interpretation” column should be taken as fact.

11.3 Definitions

CsWebServiceConfiguration Parameter Description
ShowJoinUsingLegacyClientLink If set to True, users joining a meeting by using a client application other than Lync will be given the opportunity to join the meeting. The default value is False.
ShowAlternateJoinOptionsExpanded
When set to True, alternate options for joining an online conference will automatically be expanded and shown to users. When set to False (the default value), these options will be available, but the user will have to display the list of options for themselves.

Congratulations! You made it all the way through Subpart A! I hope you’re feeling more comfortable with the purpose and scope of 21 CFR Part 11. Up next, we dive into the deep end with Subpart B – Electronic Records.

If you have questions between now and the next post, feel free to contact us. To read past posts in the 21 CFR Part 11 Decoded series, click here.

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Marin Richeson

Marin joined the life sciences industry in 2001. Over the course of her tenure, she has held roles in clinical finance, IT, quality assurance, and validation. The diversity of her experience provides her with a unique perspective on the interconnectedness of this complex, multi-faceted industry. Marin Richeson is a lead business consultant in Perficient's life sciences practice.

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