Appendix C Tracer Summit Critical Control System
248
the PC, not just the FDA compliant facility, will require operator authen-
tication for changes to the system
After the site has been commissioned and tested, use steps 1-9 above to
register the authorization code for Critical Control System(E1148 or
E1149). This registration will activate all the special Critical Control Sys-
tem features. FDA compliance requires that system changes and operator
actions must be authenticated and retained in the audit trail database.
More information is available in BMTX-SVN02A-EN.
BMTW-SVN01F-EN