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Is CaliberRM compliant to FDA ruling 21 CFR part 11?
FDA ruling 21 CFR part 11 specifies how electronic records and
signatures can be used as a substitue for paper records and hand
written signatures. It is broadly applicable to any electronic
records that are central to the process of developing and
manufacturing drugs, including software.
The attached document gives detailed information on how Borlands
ALM suite faciliates compliance to the FDA ruling.