VIDAS
®
161150-1087 - C - en – 2018-10 – P/N 161150-1246
Qualification
Protocol for the
®
VIDAS system
with VIDAS® Run
Control feature
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.
Change type categories
N/A:
Correction:
Technical change:
Administrative:
Release Date
Not applicable (First publication)
Correction of documentation anomalies
Addition, revision and/or removal of information related to the product
Implementation of non-technical changes noticeable to the user
Revision
Change Type
Change Summary
2017-06
A
N/A
First publication
2018-03
B
Administrative
4.8.1 replaced by 4.8.2 in :

The file name of the protocol.

The section Checking that the
“Configuration” menu is properly
updated.
2018-10
C
Administrative
4.8.2 replaced by 4.10 in the file name of the protocol.
Technical change
Section Checking that the “Configuration” menu is
properly updated, modification of the Note
concerning the knowledge base update in connection
with the software update.
TABLE OF CONTENTS
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
Checking that the customer settings are preserved
2 Results
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1
Qualification procedure
Introduction
This procedure should be followed to qualify your VIDAS® System after
any hardware or software modification (including Windows® and
antivirus software updates) on your computer.
It should also be performed after a specific installation (i.e on the
customer computer) and after installation of a new software patch.
CAUTION
In case of antivirus and/or Windows® security updates activation:
Before installing the antivirus software and any Windows®
update, complete all the analyses and shut down any bioMérieux
applications running on the system.
The antivirus scan parameters must be defined before this
protocol is performed.
The scan must be done when the instrument is not being used for
analyses and when automatic backup is not running.
The automatic backup of Windows® patches must not be
activated on the systems involved.
At the end of the update, the system must be rebooted following
the instructions in the User's Manual.
CAUTION!
Set automatic backup before starting the protocol.
To run the qualification, select the Complete Demographics
mode, in the configuration menu of the VIDAS® PC software.
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Scenario 1a – Create a user account (for local user
accounts only)
Following the instructions in the VIDAS® User’s Manual:
1． Create a new "standard" user’s account.
2． Choose a password (a password change will be required at first
login).
3． Open a Windows® session using this profile.
4． Start the VIDAS® PC software.
Verification:
It is possible to create a new user
account, open a Windows session and
start the VIDAS® PC software.
OK
NOK
Scenario 1b – Create a user account (for PCs included in a
domain only)
Note: This step must be performed by a local administrator or by a domain
administrator, if required.
Following the recommendations in the “VIDAS PC software installed
on Industry customer computers ADDENDUM to the User’s
Manual”:
1． Create a local user account.
2． Only select the VIDAS_ROUTINE group to give the user limited
access rights to VIDAS® PC.
3． If necessary, set the BCI group membership, as described in the
VIDAS® user’s manual.
4． Open a Windows® session with a user account from the Active
directory.
5． Start the VIDAS® PC software with the local user account created
previously.
Verification:
It is possible to open a Windows®
session and start the VIDAS® PC
software.
OK
NOK
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Scenario 2 – Read PTC barcodes (if applicable) and MLE
barcodes

Go to the "Configuration - assay activation" menu and read the
PTC barcodes (if applicable).
Verification:
OK
NOK
No error occurs during the reading.
The PTC data are printed.
The assay is added to the assay list.

Go to the “Calibration” menu and read the MLE barcode with the
barcode reader.
Verification:
OK
NOK
No error occurs during the reading.
MLE data are printed.
MLE data are properly saved in the
“Calibration” menu.
Scenario 3a – Create a work list (in connected mode)
CAUTION !
Perform this part only if the system is connected.

Send a work list from the LIMS to the VIDAS® PC.
Verification:
The list received and displayed in the
work list matches the one sent by the
LIMS.
OK
NOK
Scenario 3b – Create a work list (in non connected mode)
CAUTION !
Perform this part only if the system is not connected.
Following the instructions in the VIDAS® User’s Manual:
 create a work list.
Verification:
The work list has been correctly created.
OK
NOK
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Scenario 4 – Launch analyses

Perform the assays.
Verification:
No error messages are displayed during
the assay.
OK
NOK
OK
NOK
The correct results are printed.
Scenario 5 – "Calibrations" Menu

Go to the "Calibrations" menu.
Verification:
This menu must not be unusually slow to
open.
Scenario 6a – “Results” menu

Go to the “Results” menu (refresh the list if necessary).
Verification:
(1) The new “VRC” column is displayed.
OK
NOK
(2) The samples results are displayed.
(3) The VRC statuses are displayed.
1
2
3 Status could be
Passed or
Failed or
INVALID or
Not Run
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Scenario 6b – “Results” menu (in connected mode only)
CAUTION !
Perform this part only if the system is connected.

If the validation mode is not automatic, manually validate any
results that have not been validated.
Verification:
The biological results are sent to the
LIMS and the information matches the
results displayed in VIDAS® PC.
OK
NOK
OK
NOK
Scenario 7 – Export results
Following the instructions in the User’s Manual,
 Start the data export.
Verification:
The export file in CSV format is present
in the expected directory.
This file can be opened using Excel
The information contained in this file
matches the results displayed in
VIDAS® PC.
Scenario 8 – Manual and automatic backup
Automatic backup was configured and was therefore performed at the
time defined by the user.
Verification:
The backup file is present on the
expected storage location (correct date
and time).
OK
NOK
OK
NOK
Following the instructions in the User’s Manual,
 Start manual backup.
Verification:
The backup is performed.
The backup file is present on the
expected storage location (correct date
and time).
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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.
Ch ec k ing th at t he “Co nf igu rat io n ” me nu is pr op er ly u p d at ed
1． Click
in the main window,
2． Select “Configuration”.
3． Check the “VIDAS Run Control” submenu is displayed.
Before update
Note:
After update
®
The knowledge base is updated when VIDAS Software is updated from 4.7.1 to 4.10.
4． In the “Assay activation” submenu, check that the J9 Code for
the SET2 assay is deleted from the list (old version of the assay)
and the QB Code for the ESP1 Assay and QC Code for the ESP2
Assay are displayed in the list.
Verification:
The VIDAS Run Control submenu is
displayed.
OK
NOK
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
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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
1． Click
in the main window,
2． Select “Configuration”.
3． Check the settings of the following submenus:

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).
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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:
Routine is the same as before the update.
OK
NOK
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.
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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
Tests performed by:
Date:
VIDAS® - Qualification Protocol for the VIDAS® System with VIDAS® Run Control feature
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bioMérieux SA
376, Chemin de l’Orme 69280 Marcy-l'Etoile – France
Tel. 33 (0)4 78 87 20 00 Fax 33 (0)4 78 87 20 90
www.biomerieux.com