Establishing a Sound IT Infrastructure in a GxP Environment

With the approval of Title 21 Code of Federal Regulations (CFR) Part 111 o­n March 20, 1997, Information Technology (IT) was thrust to the forefront of the Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP), (GxP) comp l i a n c earena. Prior to the implementation of Part 11 in August 1997, I T p r i n c i p a l s were usually behind the scenes performing such critical tasks as data backup and archival, setting up access...


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