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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:
| # | Date | Filename | Type | Size |
|---|---|---|---|---|
| 26/04/2009 | Validation-PB-Systems_2292_V10_Nov04.pdf | 790 KB |
The downloads section on profibus.com offers a wealth of valuable resources that are essential for companies working in industrial automation. These documents, including technical descriptions, installation guides, and white papers, provide detailed insights into the implementation and use of PROFIBUS and PROFINET technologies. By accessing these resources, engineers and technical teams can significantly improve their understanding and efficiency in deploying robust, standardized communication solutions in industrial environments.
For companies looking to gain even more from the PROFIBUS ecosystem, becoming a member of PROFIBUS & PROFINET International (PI) offers additional benefits. Members enjoy exclusive access to advanced technical documentation, expert certification programs, and development tools that can accelerate innovation and ensure compliance with the latest industry standards. Membership also provides networking opportunities with other industry leaders, fostering collaboration and knowledge sharing, which is crucial in staying ahead in the fast-evolving automation landscape.
By joining PI, companies position themselves at the forefront of industrial communication technology, ensuring they remain competitive and well-equipped to tackle future challenges.