PROFIBUS International is publishing a new guideline, ?Validation of PROFIBUS Systems?, in which the validation-supporting functions of PROFIBUS are described. Requirements from the NAMUR recommendation NE 72, ISPE GAMP 4 and FDA 21 CRF Part 11 are taken up in this guideline and implemented.
Systems subject to validation must meet different regulations and recommendations of various institutes that were set up based on the general legal guidelines of the Food and Drug Administration (FDA) in the United States.
The validation guideline of PROFIBUS International is primarily intended for users of PROFIBUS whose systems are subject to validation. In particular, this includes plants in the food and drug industry. It is intended for decision-makers, persons in charge of industry-specific system concepts as well as persons in charge of projects and system administrators. The guideline represents the PROFIBUS qualification for supporting the validation. In addition, it describes standard operating procedures (SOP) which serve not only as configuration support, but can also be used for training purposes.
The guideline ?Validation of PROFIBUS Systems? is immediately available for download as a draft in the member area under www.profibus.com (order no. 2.292).
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