1 Introduction
16
1.6
Functions of the device version 02
New functions
The following new functions were implemented in device version 02.
•
Extra code 887 "Manipulation detection with digital certificate": manipulation detection for
the recording data by using a certificate (during saving and transfer)
•
Extra code 888 "FDA 21 CFR Part 11 with digital certificate": FDA compliant data recording
with special input masks and functions; manipulation detection with digital certificate
•
Additional user rights
•
User management with PC Security Manager software (PCS) for up to 50 users (only with
extra code 888)
•
Separate transfer of user table and user groups even for a device without extra code 888
•
Electronic signature of the batch report (only with extra code 888)
•
Electronic signature for a certain time period (only with extra code 888)
•
Electronic signature for user logoff (only with extra code 888)
•
Authentication prior to entering the comment text
•
Additional objects in process image editor: entering values and text
•
Additional barcode functions: control characters for reading event text and process values
•
General limit value monitoring functions: limit value and switching differential adjustable in
the parameterization as well as through Modbus
•
Online visualization configurable as standard version or user version
With extra code 888 the device fully supports the requirements for data recording according to
the rules 21 CFR Part 11 of the United States Food and Drug Administration.
The extra code 887 or 888 give the device a TÜV certified function for ensuring data security.
A digital device certificate provides proof that the recording data has not been manipulated in
the device or during transfer.
Changed functions
The following functions were changed from device version 01:
•
Flash manager function "Saving all recording data on USB flash drive (backup)": the user
can select a time period from which the recording data is saved. In addition, the current
readings of the counters and integrators as well as the statistic (report) – even if they have
not yet been completed – can be saved along with the recording data.
•
General limit value monitoring functions: increased amount to 24
•
Batch texts, comment text: maximum number of characters increased to 160
