MassHunter Quantitative Analysis Audit Trail And
MassHunter Quantitative AnalysisAudit Trail and ComplianceQuick Start GuideGetting Started for Users 4To log into MassHunter 4To lock your computer screen when unattended 5To use MassHunter with Compliance features 5Installation and Setup - Compliance Mode 6Step 1. Install the OpenLAB ECM server 6Step 2. Install the OpenLAB ECM client 7Step 3. Enable Compliance for Quantitative Analysis 8Step 4. Set up Users, Groups, and Roles 9Step 5. Install ECM Send To add-in 11Step 6. Copy Report Templates to the OpenLAB ECM server 12Installation and Setup - User Management and Audit Trail Only Mode 18Step 1. Enable User Management and Audit Trail Only mode 18Step 2a. Create Users and Groups 19Step 2b. Set up Roles for existing Windows Groups 20Step 3. Customize Roles 20Administration Tasks 21To open the ATM Configuration tool 21To associate Roles with Command Groups 22To enable/disable audit requirements for individual commands 23To view method audit history 24To check integrity of batch files 28To view Audit Trail 31To protect Excel reports 35To change global settings 37
Reference 39Users/Groups/Roles/Privileges/Commands 39MassHunter Quantitative Analysis Commands 41Comparing Compliance Mode with other Quantitative AnalysisModes 44Retrieve versus Checkout (Compliance Mode) 4621 CFR Part 11 is a result of the efforts of the US Food and DrugAdministration (FDA) and members of the pharmaceutical industry toestablish a uniform and enforceable standard by which the FDA will considerelectronic records equivalent to paper records and electronic signaturesequivalent to traditional handwritten signatures. For more information, ces/ucm125067.htm.MassHunter Quantitative Analysis Audit Trail and Compliance includes thefollowing features to support 21 CFR Part 11 compliance: Roles that restrict actions to certain Users Audit Trails Record Security through integration with Agilent OpenLAB EnterpriseContent Manager (ECM) Hash Signature for data files allow you to check the integrity of files duringa compliance auditBesides full Compliance mode, MassHunter Quantitative Analysis also offersthe User Management and Audit Trail Only mode, which gives you a subset ofcompliance features.This Quick Start Guide introduces you to these capabilities. See the onlinehelp for more information on these features.2MassHunter Quantitative Analysis Audit Trail and Compliance Quick Start Guide
Where to Find More InformationWhere to Find More InformationAgilent Web SiteTo view support information for MassHunter Quantitative Analysis Audit Trailand Compliance and other Agilent products, see e OnlineHelpYou can access MassHunter Workstation online help from the Help menu inthe software or by pressing the F1 key in the MassHunter Workstationwindows or dialog boxes.Other manualsAdditional user information for MassHunter software and the LC/MSinstrument can be found from the MassHunter online Help after installation.Additional user information for ECM administration tasks can be found in theonline Help for the OpenLAB ECM server. (Log onto the OpenLAB ECM Serverto access the online Help.)MassHunter Quantitative Analysis Audit Trail and Compliance Quick Start Guide3
Getting Started for UsersTo log into MassHunterGetting Started for UsersAfter Compliance mode is enabled on your system, and the OpenLAB ECMserver is installed and configured, you use the MassHunter programs exactlyas you would in standard mode, with just a few exceptions.For more information about the differences between Compliance mode andother modes, see “Comparing Compliance Mode with other QuantitativeAnalysis Modes” on page 44.To log into MassHunter1 Double-click the Quantitative Analysis program icon on your desktop.If the Compliance mode is enabled, the OpenLAB ECM Login dialog boxopens.2 Enter your Username and Password. Then, click OK.4MassHunter Quantitative Analysis Audit Trail and Compliance Quick Start Guide
Getting Started for UsersTo lock your computer screen when unattendedTo lock your computer screen when unattendedWhen you are going to be away from your computer for awhile, lock yourcomputer so that it can’t be accessed by others.1 Press Ctrl and Alt and Delete.2 Click the Lock Computer button.To unlock your computer on your return, press Ctrl and Alt and Delete,type in your password, and click OK.To use MassHunter with Compliance features If your Role is restricted, some commands in the MassHunter programs willbe unavailable to you. If validation requirements are turned on for your Role and the action thatyou are performing, you are required to enter your User name andPassword and/or a reason for any changes that you make. For example, youmay need to give a reason when you manually integrate a peak or disable acalibration point. The User Validation and Reason dialog box is displayedwhen you do the action.Figure 1User Validation and Reason dialog boxMassHunter Quantitative Analysis Audit Trail and Compliance Quick Start Guide5
Installation and Setup - Compliance ModeStep 1. Install the OpenLAB ECM serverInstallation and Setup - Compliance ModeBefore you begin, make sure that you have the OpenLAB ECM software that iscompatible with your MassHunter Data Acquisition or Quantitative Analysissoftware.Step 1. Install the OpenLAB ECM server1 If you don’t already have one installed, install an OpenLAB ECM server foryour work group.Refer to the OpenLAB ECM installation guide. Make sure that the OpenLABECM version is compatible with your version of MassHunter software.2 If the appropriate ECM Database Account has not been created yet, createone on the OpenLAB ECM server.Accounts are created to ensure that only authorized users can access dataon an OpenLAB ECM server. Users log in with a specific Account namewhen they run MassHunter Data Acquisition and Quantitative Analysis.MassHunter objects that are created and stored while logged in to anAccount can be accessed only by other users with access to that Account.6MassHunter Quantitative Analysis Audit Trail and Compliance Quick Start Guide
Installation and Setup - Compliance ModeStep 2. Install the OpenLAB ECM clientStep 2. Install the OpenLAB ECM clientDo this step on each MassHunter Workstation that has never connected to anOpenLAB ECM server.1 Connect to the OpenLAB ECM server:a In Internet Explorer, go to the OpenLAB ECM server URL. The URL istypically in the format http://ECMServerName/ecm.b In the OpenLAB ECM Login box, type in the OpenLAB ECM Usernameand Password. Click Login.The first time the OpenLAB ECM server is accessed from this MassHunterWorkstation, these components are downloaded and installed: Agilent OpenLAB ECM API Agilent OpenLAB ECM Client Agilent OpenLAB ECM ResourcesDo not install OpenLAB ECM Scheduler or Cyberprinter. They are notsupported by the MassHunter Data Acquisition program.2 On the MassHunter Workstation, add the OpenLAB ECM server to the list ofTrusted Sites:a In Internet Explorer, click Tools Internet Options Security Trusted Sites Sites.b Clear the check box for Require server verification (https:) for all sitesin this zone.c In the Add websites to the zone text box, type the URL for yourOpenLAB ECM server and click Add.d Click Close OK.e Restart Internet Explorer to apply the changes.This step allows users to retrieve files from the OpenLAB ECM serverthrough Internet Explorer. For more details on retrieving files, see “Retrieveversus Checkout (Compliance Mode)” on page 46.NOTENote that the lowest storage unit that you can define for tune files and Studies areDrawers. Tune files and Studies are stored in separate Folders within the Drawers.MassHunter Quantitative Analysis Audit Trail and Compliance Quick Start Guide7
Installation and Setup - Compliance ModeStep 3. Enable Compliance for Quantitative AnalysisStep 3. Enable Compliance for Quantitative AnalysisDo this step on each MassHunter Workstation.1 If you are doing a new system installation that includes Data Acquisition:a Install MassHunter Quantitative Analysis in standard workflow mode.b Make sure that the Quantitative Analysis program operates properly.c Continue to step 3.2 If you are doing a new offline installation:a Start the MassHunter Quantitative Analysis installation as a newinstallation.b When prompted for Feature Type, click Activate Compliance.c Continue installation as instructed in the installation guide.3 If MassHunter Quantitative Analysis is already installed in standardworkflow mode:a Click Start Control Panel Programs and Features.b Click Change.c Click Activate Compliance.d Follow the instructions as they are presented to complete activation.4 If MassHunter Quantitative Analysis is already installed in Manage Usersand Audit Trail Only mode, or a previous release is installed:a Remove the MassHunter Quantitative Analysis software.b Start the MassHunter Quantitative Analysis installation as a newinstallation.c When prompted for Feature Type, click Activate Compliance.d Continue installation as instructed in the installation guide.5 Run the ATM Configuration tool and save the settings:a From the Windows Start menu, click All Programs Agilent QuantTools ATM Configuration.b Log onto the OpenLAB ECM server as the user admin.c Click File Save. Then click File Exit.This step installs Quantitative Analysis Privileges on the OpenLAB ECMserver. You do this step only once for each ECM Server.8MassHunter Quantitative Analysis Audit Trail and Compliance Quick Start Guide
Installation and Setup - Compliance ModeStep 4. Set up Users, Groups, and RolesStep 4. Set up Users, Groups, and RolesAccess to the Quantitative Analysis program is determined by the Groups andRoles that are set up on the OpenLAB ECM server. You can change thesesettings from the MassHunter Workstation. See “To associate Roles withCommand Groups” on page 22.1 Connect to the OpenLAB ECM server:a In Internet Explorer, go to the OpenLAB ECM server URL. The URL istypically in the format http://ECMServerName/ecm.b In the OpenLAB ECM Login box, type in the OpenLAB ECM Usernameand Password. Click Login.2 Click the Admin tab, then click Account Administration.3 Click Users/Groups/Roles to open the Account Administration window.4 If you are not using your organization’s Windows domain to control access,create an ECM User for each user. These ECM Users become part of theBUILT-IN domain.MassHunter Quantitative Analysis Audit Trail and Compliance Quick Start Guide9
Installation and Setup - Compliance ModeStep 4. Set up Users, Groups, and Roles5 Set up MassHunter Quantitative Analysis ECM Users and Roles:a Optional. Create ECM User Groups for MassHunter QuantitativeAnalysis. Assign each User to one User Group.For example, you can create the “Developers” Group for users who needaccess to all Quantitative Analysis commands, and “Analysts” for userswho need access to just a part of the commands.b Create ECM Roles for different classes of users, such as “Developers” and“Analysts”. Add Users and Groups to each Role.c Assign Quantitative Analysis Privileges to each Role.Four built-in Quantitative Analysis Privileges are available: MassHunter Quantitative Analysis: Batch Analysis MassHunter Quantitative Analysis: Batch Review MassHunter Quantitative Analysis: Report MassHunter Quantitative Analysis: Method DevelopmentThese Privileges are installed on the OpenLAB ECM server the first timean ATM Configuration is saved from a connected MassHunterWorkstation Quantitative Analysis session.d Add the Privilege Contributor and Folder Administrator to each Role.This Privilege lets users read, create, and retrieve files and folders on theOpenLAB ECM server.e Assign each User and Group to a Quantitative Analysis Role.The Privileges that are assigned to each ECM Role determines theCommand Groups that each user in that Role can access on anyMassHunter Workstation, while logged into the same ECM account.These Role assignments can also be done on any MassHunter Workstationin the ATM Configuration tool.6 Ask each user to verify his or her account:a Log into the MassHunter Workstation.b Open Internet Explorer and go to the OpenLAB ECM URL. The URL istypically in the format:http://ECMServerName/ecmc Create a folder within the user’s assigned ECM environment.d Upload a file to the user’s assigned ECM environment.10MassHunter Quantitative Analysis Audit Trail and Compliance Quick Start Guide
Installation and Setup - Compliance ModeStep 5. Install ECM Send To add-inStep 5. Install ECM Send To add-inIf you want to transfer files to the OpenLAB ECM server outside of theMassHunter program (such as to copy report templates to the server), installthe Send To add-in.Do this on each MassHunter workstation.1 Connect to the OpenLAB ECM server:a In Internet Explorer, go to the OpenLAB ECM server URL. The URL istypically in the format http://ECMServerName/ecm.b In the OpenLAB ECM Login box, type in the OpenLAB ECM Usernameand Password. Click Login.2 Click the Administration tab.3 Click Downloads.4 Click ECM SendTo Add-in for Windows Explorer.5 Follow the instructions as they are presented to complete the installation.6 Log off of the OpenLAB ECM Server, then log back in.7 If you are asked to install updates, follow the instructions to do so. Log offthe OpenLAB ECM server, then log back in. Continue to install updates ifyou are prompted to do so.MassHunter Quantitative Analysis Audit Trail and Compliance Quick Start Guide11
Installation and Setup - Compliance ModeStep 6. Copy Report Templates to the OpenLAB ECM serverStep 6. Copy Report Templates to the OpenLAB ECM serverIf Report Templates were installed on the MassHunter Workstation, uploadthem to a location in ECM that MassHunter Quantitative Analysis users will beable to access.Copy only the templates that you need.1 Connect to the OpenLAB ECM server:a In Internet Explorer, go to the OpenLAB ECM server URL. The URL istypically in the format http://ECMServerName/ecm.b In the OpenLAB ECM Login box, type in your OpenLAB ECM Usernameand Password. Click Login.2 On the OpenLAB ECM server, create or identify folders to store the reporttemplates.As an example, in the location of your choice, create the cabinet ReportTemplates. In the Report Templates cabinet, create drawers named PDFand Excel. In each of these drawers, create folders named Quant andUnknowns.3 In a Windows Explorer window, open the folder \MassHunter\Report Templates\Quant\PDF-Reporting.4 Select all the files, right-click the selection, and click Send to AgilentOpenLAB ECM.If you don’t see the Send to Agilent OpenLAB ECM command, do thesteps in “Step 5. Install ECM Send To add-in” on page 11.12MassHunter Quantitative Analysis Audit Trail and Compliance Quick Start Guide
Installation and Setup - Compliance ModeStep 6. Copy Report Templates to the OpenLAB ECM serverMassHunter Quantitative Analysis Audit Trail and Compliance Quick Start Guide13
Installation and Setup - Compliance ModeStep 6. Copy Report Templates to the OpenLAB ECM server5 In the Agilent OpenLAB ECM Send Files window: For Destination, navigate to the folder .\Report Templates\PDF\Quant that was just created. Click Upload.14MassHunter Quantitative Analysis Audit Trail and Compliance Quick Start Guide
Installation and Setup - Compliance ModeStep 6. Copy Report Templates to the OpenLAB ECM server6 In the Add File dialog box, mark the Apply to all files check box. Ifprompted, type a reason. Click OK.7 In the Windows Explorer window, right-click the folder Codes, then clickSend to Agilent OpenLAB ECM.MassHunter Quantitative Analysis Audit Trail and Compliance Quick Start Guide15
Installation and Setup - Compliance ModeStep 6. Copy Report Templates to the OpenLAB ECM server8 In the Agilent OpenLAB ECM Send Files window: For Destination, navigate to the folder .\Report Templates\PDF\Quant that was just created. Set Profile to 05. Upload a MassHunter Data Folder - Standard Profile. Click Upload.9 In the Agilent OpenLAB ECM Send Files - Upload Information dialog box,click Upload.10 In the Add File Dialog, click OK.11 Repeat step 3 through step 10, but with the source and destination foldersand locations in Table 1.Table 1Source and destination folders for report templatesContentWindows FolderOpenLAB ECM server foldersFiles\MassHunter\Report Templates\Quant\PDF-Reporting\Unknowns.\Report Templates\PDF\UnknownsFolder\MassHunter\Report rt Templates\PDF\UnknownsFilesMassHunter\Report Templates\Quant\en-US\Letter\ISTD\Parts Graphics*.\Report Templates\Excel\QuantFilesMassHunter\Report Templates\Quant\en-US\Letter\ISTD\Parts Graphics*.\Report Templates\Excel\QuantFilesMassHunter\Report Templates\Quant\en-US\Letter\Unknowns*.\Report Templates\Excel\Unknowns* These files are in English, for letter-sized paper. Choose the appropriate source folder for your language and locale.16MassHunter Quantitative Analysis Audit Trail and Compliance Quick Start Guide
Installation and Setup - Compliance ModeStep 6. Copy Report Templates to the OpenLAB ECM serverIf Excel report templates need to be customized, check out the report templatefrom the OpenLAB ECM server. Make the needed changes, test the changes,then check the file back in.If you want to use the Excel version of the Quantitative Analysis Audit Trailreport template instead of the PDF version, make sure you copyQuantReport AuditTrail B 06 00.xltx in MassHunter\Report Templates\Quant\en-US\Letter\Compliance to the OpenLAB ECM server.If multiple language or paper sizes are required, create separate folders on theOpenLAB ECM server with descriptive names, such as “Quant - Eng A4”.Unlike PDF report templates, Excel report templates are fixed to a singlelanguage and paper size.MassHunter Quantitative Analysis Audit Trail and Compliance Quick Start Guide17
Installation and Setup - User Management and Audit Trail Only ModeStep 1. Enable User Management and Audit Trail Only modeInstallation and Setup - User Management and Audit Trail Only ModeStep 1. Enable User Management and Audit Trail Only mode1 If MassHunter Quantitative Analysis is not already installed:a Start the MassHunter Quantitative Analysis installation.b When prompted, click Activate User Management and Audit Trail Only.c Follow the instructions as they are presented to complete activation.2 If MassHunter Quantitative Analysis is already installed in standardworkflow mode:a Click Start Control Panel Programs and Features.b Click Change.c Click Activate User Management and Audit Trail Only.d Follow the instructions as they are presented to complete activation.18MassHunter Quantitative Analysis Audit Trail and Compliance Quick Start Guide
Installation and Setup - User Management and Audit Trail Only ModeStep 2a. Create Users and GroupsStep 2a. Create Users and GroupsDo this step to create Users and Groups on the computer where you arerunning MassHunter Quantitative Analysis program.Refer to instructions from Microsoft to create Users and Groups.NOTEIf you prefer to use existing Windows Groups to assign Roles, skip to “Step 2b. Set up Rolesfor existing Windows Groups” on page 20.1 If needed, create a User account for each user.2 Create these new groups. Make sure they are spelled exactly as shown: QuantAdministrators QuantBatchAnalyzer QuantBatchReviewer QuantMethodDeveloper QuantReportGenerator3 Add each User to a Group based on the role that they will play in yourlaboratory.You can also add Users to the Groups as you create each Group.If you are using the Study Manager program and submitting a Bioanalysisstudy, make sure that the person using the Study Manager program hasthe correct permissions for the Quantitative Analysis program. See theStudy Manager Quick Start Guide for a list of the permissions that aperson submitting a Bioanalysis study needs.MassHunter Quantitativ
a Install MassHunter Quantitative Analysis in standard workflow mode. b Make sure that the Quantitative Analysis program operates properly. c Continue to step 3. 2 If you are doing a new offline installation: a Start the MassHunter Quantitative Analysis installation as a new installation. b W
MassHunter supports only Microsoft Excel 2013, or Microsoft Office 2013. 1 Close all MassHunter Workstation programs. 2 Make sure that the DA Reprocessor program is not running. 3 Start the installation: a Follow the instructions that came with the Microsoft Excel or Microsoft Office software or Product Key to start the installation.
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To open Optimizer Open MassHunter Optimizer in either of the following ways: Double-click the Optimizer icon on the desktop, or Select Programs Agilent MassHunter Workstation Optimizer from the Windows Start menu. To open Optimizer for Peptides A version of MassHunter Optimizer is available for optimizing peptides. Open
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