The Requirements of FDA's 21 CFR Part 11 and Software Programs That Meet the Requirements

With the increased use of electronic records in the Biotechnology Industry, there became a need for requirements to address data security, data integrity and traceability of this data. In response, the Food and Drug Administration (FDA) published a regulation called 21 CFR Part 11 (August, 1997.)...
By Kristine Safi
January 19, 2005

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