Establishing Compliance of Batch SCADA Systems with FDA cGMP 21 CFR Part 11

Overview:

FDA enforcement of a 1997 cGMP regulation, 21 CFR Part 11, for electronic records and signatures, is imminent. Compliance policy Guidelines were issued May 1999 to clarify the agency’s expectations of pharmaceutical and medical device manufacturers. FDA scrutiny of system implementations is anticipated to be extensive. The popular use of “open” architectures and commercial-off-the-shelf software products for automated batch control and data management has introduced 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. Regulatory requirements shall be reviewed, with real-world examples of assessment and compliance resolution for Batch SCADA Systems. System functionality requirements shall be stressed without direct reference to product or service brand names.

Author: Stanley L. Whitman, Consulting Project Manager, Raytheon Consulting & Systems Integration Inc.  | File Type: PDF

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