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User Manual Supplements - 161150-1087 - C - en - VIDAS 4.10 Qualification Protocol
User Manual Supplements - 161150-1087 - C - en - VIDAS 4.10 Qualification Protocol
VIDAS
Qualification
Protocol for the
®
VIDAS system
with VIDAS® Run
Control feature
161150-1087 - C - en – 2018-10 – P/N 161150-1246
INDUSTRY USE - EN
Revision Table
This section contains a summary of changes made to each released revision of this protocol starting
with part number 161150-1087 - A.
2018-10 C Administrative 4.8.2 replaced by 4.10 in the file name of the protocol.
1 Qualification procedure 2
Introduction ......................................................................................................................... 2
Scenario 1a – Create a user account (for local user accounts only) .................................. 3
Scenario 1b – Create a user account (for PCs included in a domain only) ........................ 3
Scenario 2 – Read PTC barcodes (if applicable) and MLE barcodes ................................ 4
Scenario 3a – Create a work list (in connected mode) ....................................................... 4
Scenario 3b – Create a work list (in non connected mode) ................................................ 4
Scenario 4 – Launch analyses ........................................................................................... 5
Scenario 5 – "Calibrations" Menu ....................................................................................... 5
Scenario 6a – “Results” menu ............................................................................................ 5
Scenario 6b – “Results” menu (in connected mode only)................................................... 6
Scenario 7 – Export results ................................................................................................ 6
Scenario 8 – Manual and automatic backup ...................................................................... 6
Scenario 9 – Customer settings ......................................................................................... 7
Checking that the “Configuration” menu is properly updated 7
Checking that the customer settings are preserved 8
2 Results 10
VIDAS® - Qualification Protocol for the VIDAS® System with VIDAS® Run Control feature 1
161150-1087 - C
1 Qualification procedure
Introduction
VIDAS® - Qualification Protocol for the VIDAS® System with VIDAS® Run Control feature 2
161150-1087 - C
Scenario 1a – Create a user account (for local user
accounts only)
Verification: OK NOK
It is possible to create a new user
account, open a Windows session and
start the VIDAS® PC software.
Verification: OK NOK
It is possible to open a Windows®
session and start the VIDAS® PC
software.
VIDAS® - Qualification Protocol for the VIDAS® System with VIDAS® Run Control feature 3
161150-1087 - C
Scenario 2 – Read PTC barcodes (if applicable) and MLE
barcodes
Verification: OK NOK
No error occurs during the reading.
Go to the “Calibration” menu and read the MLE barcode with the
barcode reader.
Verification: OK NOK
No error occurs during the reading.
Verification: OK NOK
The list received and displayed in the
work list matches the one sent by the
LIMS.
Verification: OK NOK
The work list has been correctly created.
VIDAS® - Qualification Protocol for the VIDAS® System with VIDAS® Run Control feature 4
161150-1087 - C
Scenario 4 – Launch analyses
Verification: OK NOK
No error messages are displayed during
the assay.
The correct results are printed.
Verification: OK NOK
This menu must not be unusually slow to
open.
Verification: OK NOK
(1) The new “VRC” column is displayed.
(2) The samples results are displayed.
(3) The VRC statuses are displayed.
3 Status could be
2
Passed or
Failed or
INVALID or
Not Run
VIDAS® - Qualification Protocol for the VIDAS® System with VIDAS® Run Control feature 5
161150-1087 - C
Scenario 6b – “Results” menu (in connected mode only)
Verification: OK NOK
The biological results are sent to the
LIMS and the information matches the
results displayed in VIDAS® PC.
Verification: OK NOK
The export file in CSV format is present
in the expected directory.
Verification: OK NOK
The backup file is present on the
expected storage location (correct date
and time).
Verification: OK NOK
The backup is performed.
The backup file is present on the
expected storage location (correct date
and time).
VIDAS® - Qualification Protocol for the VIDAS® System with VIDAS® Run Control feature 6
161150-1087 - C
Scenario 9 – Customer settings
CAUTION! To access the Configuration menu and its submenus, you must
have logged on with a user identifier that belongs to the
VIDAS_ADMIN group.
®
Note: The knowledge base is updated when VIDAS Software is updated from 4.7.1 to 4.10.
Verification: OK NOK
The VIDAS Run Control submenu is
displayed.
The J9 Code for the SET2 assay is deleted
The QB Code for the ESP1 Assay and the
QC Code for the ESP2 Assay are
displayed
VIDAS® - Qualification Protocol for the VIDAS® System with VIDAS® Run Control feature 7
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Ch ec k ing th at t he c us to me r se tt ings ar e p re se r ve d
Routine
The Usual services / Print services / Results validation before
transmission settings should be the same as before the update
(screen copy given as an example).
Assay assignment
The Assay assignment settings should be the same as before the
update (screen copy given as an example).
VIDAS® - Qualification Protocol for the VIDAS® System with VIDAS® Run Control feature 8
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Profiles
If profiles were created before the update, these profiles should be the
same as before the update (screen copy given as an example).
Link BCI
If the VIDAS® system is connected to the LIMS, the Link BCI settings
should be the same as before the update (screen copy given as an
example).
Verification: OK NOK
Routine is the same as before the update.
Assay assignment is the same as before
the update
Profiles (if created) are the same as
before the update.
Link BCI is the same as before the
update.
VIDAS® - Qualification Protocol for the VIDAS® System with VIDAS® Run Control feature 9
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2 Results
VIDAS® software
Version: ………………………………..
RESULTS OK NOK
Scenario 1a – Create a user account (for local user
accounts only)
Scenario 1b – Create a user account (for PCs included in
a domain only)
Scenario 2 – Read PTC barcodes (if applicable) and MLE
barcodes
Scenario 3a – Create a work list (in connected mode)
Scenario 3b – Create a work list (in non connected mode)
Scenario 4 – Launch analyses
Scenario 5 – "Calibrations" Menu
Scenario 6a – “Results” menu
Scenario 6b – “Results” menu (in connected mode only)
Scenario 7 – Export results
Scenario 8 – Manual and automatic backup
Scenario 9 – Customer settings
VIDAS® - Qualification Protocol for the VIDAS® System with VIDAS® Run Control feature 10
161150-1087 - C
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