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Achieving 21 CFR Part 11 Compliance Using CENTUM VP
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, (21 CFR Part 11), 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.
A detailed analysis of Part 11 was performed, the results of which are listed in the Detailed Part 11 Compliance section (section 5) of this document, which supports the compliance of the CENTUM VP system to Part 11.
CENTUM VP is a comprehensive software package containing configurable functions that support Part 11 compliance (audit trails, electronic signatures and electronic records). The system capitalizes on its Part 11 compliance attributes in the marketing strategy of supplying FDA regulated industries with state of the art automation capabilities.
User training and education as well as the development and utilization of policies and procedures are key components of Part 11 compliance which must be established by the user.
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