Monday, April 18, 2011 10:51 AM
Enabling 21 CFR Part 11 Compliance
By Christine Hansen
FDA 21 CFR Part 11 provides, in particular, regulations that enable device manufacturers to use electronic records and signatures in a manner equivalent to paper-based records and hand signatures. However, FDA does not specify how companies must address these requirements, but rather provides a set of guidelines based on common sense and good workflow processes. This paper describes how an ideal enterprise software solution can enable device makers to fulfill these demands.
Complying with FDA regulations requires enormous volumes of documentation. At one time, life sciences companies literally shipped truckloads of documents to FDA to meet their regulatory requirements. To streamline work processes related to this documentation, manufacturers began looking to manage documents electronically. However, because electronic documents are subject to greater risks of falsification, misrepresentation, and change without leaving evidence than paper records, FD more...
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Thank you!
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Wednesday, May 18, 2011 by
SR, thanks for your comments. These have been addressed - Ed.
Thursday, May 12, 2011 by
SR, thanks for your comments. These have been addressed - Ed.
Saturday, May 07, 2011 by
Thank you Christine for a great overview. A couple of minor typos:
under "Retaining information about electronic signatures:" it says "The data and time when the signature was executed". It should say:"The date and time..."
The penultimate paragraph says:"non-repudiateable". I don't believe that's an English word.
Best,
SR
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