100-412-234 REV. 06 35
2.7 21 CFR Part 11 Capability
The Branson 2000Xc welding system is capable of helping the user meet FDA’s 21 CFR
Part 11 regulations. The 2000Xc system should be set to Authentication mode to when
complying to 21 CFR Part 11 requirements. The intended use is for Subpart B-Closed
Systems- Section 10, since the 2000Xc produces and stores data.
The data generated from the 2000Xc are in readable format and can be copied in a PDF
format to a USB flash drive or downloaded from the Ethernet port using webservices. The
data in the 2000Xc is buffered and saved in the system but is limited in storage capacity.
To open up storage capacity for new data, the current data can be copied to a USB flash
drive or downloaded with webservices. After copying or downloading the data can be
deleted.
User authorized access and authority check security is set in the 2000Xc configuration.
Controls can be setup to govern frequency of password change, idle log out time, and
ability to disable accounts. User IDs must be unique and industry standards for password
complexity are used.
Audit trails are accessible from the event history screen. Changes made to validated weld
presets, system configuration, and user ID authority table are recorded in the event
history along with the logged in user, time, date, and comments for the changes made.
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