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Validation of PROFIBUS Systems

PROFIBUS

Description:

The focus is on pharmaceutical applications that are required to adhere to Current Good Manufacturing Practice (cGMP) in meeting the regulations of national authorities as inspected and enforced by them. For example the Food and Drug Administration (FDA) with the Code of Federal Regulations (CFRs) of the USA.
This guideline addresses each ”phase” of Validation as it applies to new applications with PROFIBUS based automation systems from PI members, including the process management functions. Within the scope of validation for an entire, automated production plant / process, the PROFIBUS based automation systems is only a component part. This guideline will assist the reader in understanding and generating the procedures, documentation and information necessary to qualify a PROFIBUS based automation system.
This guideline does not include the qualification of the controlled function (e.g., process equipment) and associated operating procedures, or other systems not provided by PROFIBUS devices.
This guideline represents the PROFIBUS qualification for supporting the validation. It offers arguments for the use of PROFIBUS in systems requiring validation based on GAMP 4, NAMUR and FDA requirements. In addition, it describes standard operating procedures (SOP) to support the configuration, It can also be used for training purposes.

Details:
Version: 1.0
Order No.: 2.292
Language: English

Files:
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# Date Filename Type Size
26/04/2009 Validation-PB-Systems_2292_V10_Nov04.pdf pdf 790 KB

Le nostre tecnologie

PROFIBUS è un sistema di comunicazione digitale standardizzato ed aperto, utilizzabile in tutte le aree di applicazione, dal manifatturiero al processo.

PROFINET è l'innovativo standard aperto per l'Industrial Ethernet. E' in grado di soddisfare tutti i requisiti necessari per le applicazioni di automazione industriale.

IO-LINK è la prima tecnologia IO standardizzata a livello mondiale (IEC 61131-9) per comunicare con sensori ed attuatori sotto il livello di comunicazione del bus di campo. Può essere integrata con PROFIBUS e PROFINET.