Achieving 21 CFR Part 11 Compliance Using CENTUM VP

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Achieving 21 CFR Part 11 Compliance Using CENTUM VP

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This technical white paper will discuss Yokogawa’s CENTUM VP DCS (Distributed Control System) product, hereafter referred to as ”CENTUM VP”, and the extent of its compliance with Part 11 of Title 21 of the Code of Federal Regulations the Electronic Records / Electronic Signatures Rule. CENTUM VP Batch Management is the optional Batch control function for CENTUM VP, which provides recipe management and process management functionality based upon the ISA-88 Batch Control System standard. This whitepaper addresses the use of CENTUM VP and the Batch Management function.

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