Security & Fda 21 Cfr Part 11 Compliance - Brainchild VR18 User Manual

4.6 Security & FDA 21 CFR part 11 compliance
In 4.4 Instrument, in column Security select Normal or higher security CFR-21. If the normal security is
selected, for different users it needs just to key in a common password in maximum 8 characters. Once the
password has been entered, the user needs to key in the password whenever Config, Dump, Clear or
Operate soft keys are required. These keys enable the user to do configuration, dump data, clear data or
manually operate the job. For easy access Config, Dump, Clear or Operate soft keys, the user may
ignore the password.
If the higher security CFR-21 is selected, it is required to operate the recorder in more restricted rules
which are complied with FDA 21 CFR part 11. This higher security defines two types of users including
Supervisor and Operator with different authority to access the recorder by using different passwords as
Figure 4-12. It has time limit during operation. If hands are off from keys in 10 minutes, the user needs to
key in password again. It also offers audit trail function to record the user, the timing and what type work
he was doing on the recorder before. Incorrect password and unauthorized operation will be recorded into
the event list as well.
Figure 4 – 12
Security level:
Supervisor: The top Supervisor can define all the user names including other Supervisors and Operators
total in 30 numbers including him. He can access all the keys too, and his Time of validity for the
password is unlimited.
Operator: He can access vertical keys to view the historical data, events and status but no authority to
access horizontal keys to do configuration, neither to dump, clear data.
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