FDA Part 11 Compliance and Cubby

Many customers ask if Cubby may be considered as a data storage solution for clinical researchers who are responsible for ensuring that their studies are in compliance with federal regulation 21 CFR Part 11 (Part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures). The role of Cubby is to provide data storage without compromising compliance. There is currently no FDA Part 11 evaluation or certification process for third party applications like Cubby. This means that it is not entirely accurate to ask “Is Cubby FDA Part 11 Compliant?” The valid question is “How does Cubby help organizations comply with FDA Part 11 requirements?” LogMeIn encourages Cubby users who plan on storing and sharing research information through Cubby to review all security features and properly configure Cubby to achieve compliance with applicable requirements.

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