FDA Compliance
- gok
- Posts:1
- Joined: Wed May 27, 2015 8:36 am
FDA Compliance
Can WinCC OA be used in a project that has to be compliant with the FDA Part 11? Like in Pharmacy and F&B business
- kkembel
- Posts:12
- Joined: Wed Dec 18, 2013 9:44 pm
Re: FDA Compliance
Short answer is yes... WinCC OA can be configured to conform to CFR 21 part11 standards. As with any SCADA program, compliance requires an Audit trail (can be enabled in OA) as well Access Control using Windows Domain User (from an Active Directory server) mapping for User Administration. The rest is a matter of hardening OA Project access using authorization levels, etc..
- leoknipp
- Posts:2928
- Joined: Tue Aug 24, 2010 7:28 pm
Re: FDA Compliance
Hello,
yoiu can also have look at some documents in the Download section in the ETM Portal.
There you can find information concerning topics which also refer to FDA topics.
https://portal.etm.at/index.php?option= ... &Itemid=81
https://portal.etm.at/index.php?option= ... &Itemid=81
Best Regards
Leopold Knipp
Senior Support Specialist
yoiu can also have look at some documents in the Download section in the ETM Portal.
There you can find information concerning topics which also refer to FDA topics.
https://portal.etm.at/index.php?option= ... &Itemid=81
https://portal.etm.at/index.php?option= ... &Itemid=81
Best Regards
Leopold Knipp
Senior Support Specialist