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 VIDAS® - Qualification Protocol for the VIDAS® System with VIDAS® Run Control feature 161150-1087 - C 7 8 10 1 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. VIDAS® - Qualification Protocol for the VIDAS® System with VIDAS® Run Control feature 161150-1087 - C 2 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 VIDAS® - Qualification Protocol for the VIDAS® System with VIDAS® Run Control feature 161150-1087 - C 3 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 VIDAS® - Qualification Protocol for the VIDAS® System with VIDAS® Run Control feature 161150-1087 - C 4 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 VIDAS® - Qualification Protocol for the VIDAS® System with VIDAS® Run Control feature 161150-1087 - C 5 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). VIDAS® - Qualification Protocol for the VIDAS® System with VIDAS® Run Control feature 161150-1087 - C 6 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 VIDAS® - Qualification Protocol for the VIDAS® System with VIDAS® Run Control feature 161150-1087 - C 7 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). VIDAS® - Qualification Protocol for the VIDAS® System with VIDAS® Run Control feature 161150-1087 - C 8 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. VIDAS® - Qualification Protocol for the VIDAS® System with VIDAS® Run Control feature 161150-1087 - C 9 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 161150-1087 - C 10 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