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Author Topic: 21CFR11, ediscovery and ELN software  (Read 930 times)

CERF rob

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21CFR11, ediscovery and ELN software
« on: 02-18-10 at 12:21 pm »

Electronic Laboratory notebooks (ELNs) are becoming increasingly popular and important because of government regulations such as 21CFR11, which specify how records must be created, digitally authenticated and archived if they are to be used in IP, legal or regulatory proceedings. Ample case history now shows that erecords are admissible, although very little if any case law deals with ELNs specifically, partly because nobody has attempted to challenge data stored in an ELN system, which is in itself an indicator of its reliability. One example of a modern ELN is CERF by Rescentris Inc (http://www.rescentris.com). CERF is the only client-server enterprise ELN that is both Mac and Windows compatible and fully 21CFR11 compliant. It includes advanced features such as semantic metadata searches, automated data capture and drag and drop convenience that allow investigators to import data from any source. Does anyone else have experience with, or recommendations for using ELNs in government or other tightly regulated laboratories?
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