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In March of 1997, the Food and Drug Administration (FDA) released 21 CFR Part II, the Final Rule on Electronic Records and Electronic Signatures. This ruling relates to the use of electronic systems as a means of recording and maintaining Good Manufacturing Practice (GMP) related activity and has a large impact on FDA regulated industries. This paper will review the FDA 21 CFR Part II Final Rule, describe the impact of this ruling on FDA regulated industries, and define the required components of PC-based batch systems to facilitate compliance.
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