16.3 Enable United States Food and Drug Administration (FDA)
21CFR Part 11 Compliance
16.3.1 FDA 21CFR Part 11 compliant functions
Some functions can only be accessed with 21 CFR Part 11 compliance enabled.
To comply with FDA 21CFR Part 11 standards, the user will be asked to enter a
username and password to either give approval or to access certain features.
The events that occur on the pump are recorded in the batch reports and audit trail
logs.
If FDA 21CFR Part 11 compliance is enabled, the following functionality applies;
l
Usernames must be typed—"Logging in to the pump" on page 145
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Passwords are required for all users—"Switching the pump on for the first time"
on page 45, "Users" on page 110.
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User accounts are blocked after a number of incorrect entry’s— "Log in" on
page 53.
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Passwords expire after a set duration—"Password expiry duration" on page 109.
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Session timeout period cannot be disabled— "Session timeout period" on
page 109.
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The users password must be re- entered to ‘sign’ the report at the end of a
batch—"First user batch approval" on page 91.
l
A second user must approve a batch report before it can be saved to PDF—
"Export as PDF" on page 155
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Service access to the pump can be blocked—"Users" on page 110.
i
When FDA 21CFR Part 11 compliance is enabled, there
must be at least two user accounts to allow a second user
to approve a batch report before it can be saved to PDF. To
create a second user account refer to "Users" on page 110.
i
The option to enable or disable FDA 21CFR Part 11
compliance is only available during initial setup. To change
FDA 21CFR Part 11 compliance between enabled or
disabled, factory reset the pump. (Refer to "Backup and
reset" on page 116).
PF7/PF7+ Peristaltic Filler with QC14 Pumphead User Manual
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