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| 9/27/2023 6:09 AM | |
Joined: 1/21/2013 Last visit: 12/20/2024 Posts: 3396 Rating:
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Hi Javertz, The WinCC Audit Option is based on the requirements of FDA 21 CFR Part 11. This applies to the WinCC Unified Audit Basis as well as to the Audit Options for the other WinCC systems. However, as far as I know, there is no certificate that confirms compliance with FDA 21 CFR Part 11. To be honest, I do not know of any such confirmation for the other systems either. In my opinion it would be best to ask your local sales representative or create a support request. Kind regards |
| 9/28/2023 8:50 AM | |
Joined: 8/3/2009 Last visit: 12/19/2024 Posts: 14458 Rating:
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Hello S7-Javertz_02 I think there is also an ERES document available for WinCC Unfied: https://support.industry.siemens.com/cs/de/en/view/109822485 Check if there are the needed information Bye Murof |
Last edited by: Murof at: 09/28/2023 08:51:34If this Information really helps, you could use the Rate function |
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| 10/3/2023 3:46 PM | |
Joined: 6/9/2021 Last visit: 12/18/2024 Posts: 25 Rating:
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Thank both for your answers!!!!! |
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