FDA enforcement of a 1997 CGMP regulation 21 CFR Part 11 for electronic records andsignatures is imminent and anticipated to be extensive.The popular use of open architectures and commercial off-the-shelf software products for automated batch control and data management hasintroduced many challenges to compliance with this regulation. In addition, legacy systems are not exempt, and verification of data integrity compliance is expected to be retroactive.Batch SCADA systems have the proven ability to reduce costs and improve product consistency, and the industry is heavily dependent upon their continued application in the manufacturing environment. In this article, regulatory requirements are reviewed with real-world examples of assessment and compliance resolution for Batch SCADA systems. System functionality requirements are stressedwithout direct reference to product or service brand names. (This article is excerpted from apaper presented at the 2000 North American World Batch Forum held in Atlantic City, NJ.)

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