Torque Filtering; Cfr Part 11 Compliance (Compliant Instruments Only) - Ametek BROOKFIELD DVNext Operation Instructions Manual

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5.4.11 Torque filtering

Torque filtering is an option that is available on the DVNext. When torque filtering is turned on, quickly changing
torque values are dampened. Through enabling torque filtering allows for the performance of the DVNext to meet
the same performance of the Legacy DV-II and DV-III viscometers. The administrator is able to enable or disable this
setting.

5.5 21 CFR Part 11 compliance (compliant instruments only)

The Compliant Edition DVNext provides features for 21 CFR Part 11 compliance. These features include:
Password protection and Lockout
Electronic Signatures
Multiple User Access Levels
Multiple User logins
Archiving
Audit Trail
Uneditable PDF File Format
These ensure that the system performs record retention, protection, and allows for the systems administrator to
track the actions of the individual users on the DVNext.
Password protection and lockout
The DVNext device features password protection and a lockout feature. The device can be set up to disable a user's
account after a specified number of failed login attempts. Password policies for the device can also be set up. These
include a minimum length requirement, options to require a capital letter, number, or special character. In addition to
this, the device can be set up to have user passwords expire after a specified length of time, with a warning set up to
alert the user a specified length of time before the expiration. In addition to password protection, the device can be
set up to lock users out after a specified period of inactivity. Alternatively, a manual lockout can also be used.
All of the settings for password protection and lockout settings are only available to the Administrator account on the
device.
Electronic Signatures
The DVNext device features electronic signatures. The electronic signatures feature can be enabled by the admin
under the Electronic Signatures menu in Admin Functions by selecting the "Data files must be signed" option. From
this menu, the Admin can set the approval work-flow as well: Submit/Approve or Submit/Review/Approve. A user's
individual signature role can be set during the creation of the user profile or can be changed through the Edit Users
menu. From there, the user can be assigned to either the submitter (default), reviewer, or approver role. These
electronic signatures can be added to any data file by selecting the drop-down menu and selecting signatures. This
M19-2101 REVISION 2.0
Figure 5-16
D V N E X T R H E O M E T E R - O P E R AT I O N A L M A N U A L
Figure 5-17
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