Here are the steps to access LabVantage and complete the requested exercises:
1. Open your web browser and navigate to the LabVantage training URL provided by your administrator.
2. Sign in using the username and password provided for the training database.
3. Click on your profile menu and select "Startup Page" then choose the "LIMS" site map.
4. Click the bulletin envelope icon and view any available bulletins, then mark them as read.
5. Click the help icon and browse the available help documentation.
6. When finished, click the profile menu again and select "Log Off" to properly close your session.
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Introductions - Welcome
Instructor:
Anass BOUNHAR
Team Lead & Senior SE
abounhar@labvantage.com
Learners:
SEs
LabVantage Morocco
Beginner
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LV Familiarization Training Course Agenda Overview
Day 1:
Overview
The Site Maps
Master Data
Sample Life Cycle
Day 2:
Physical Storage
Performing Queries Searches
Batches: AQM, AQC, Sample Grouping
Request Management
Day 3:
Instruments & Analysts
Consumables
Conclusion
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What is LabVantage LIMS?
Manufacturing
Data
Specifications
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What Functionality is Included?
Full Sample life cycle management
Lot and batch management
Complete lot genealogy and quality dispositioning
Stability testing and inventory management templates
Label printing, reporting and charting
Automated calculations and specification checking
Instrument calibration and maintenance
Analyst training and qualification tracking
Reagent/consumables inventory tracking
Regulatory compliance suite
Company Confidential – LabVantage Solutions, Inc.
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Component Landscape
LabVantage employs a 3-tier architecture
Application Server Reports Server
Database
Overview and Architecture
Safari
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General Workflow - Manufacturing
Material is
manufactured or
purchased
Technician takes a
Sample of the
material, recording
critical information
Sample is logged in
LabVantage and
label is generated
Laboratory receives
Sample from
technician
Testing for Sample is
added to a “QC
Batch”
Analyst performs
testing on a batch of
Samples and
performs data entry
Analyst reviews
test results for
completeness and
accuracy
Lab Manager
assigns a Sample
disposition
Quality Release
reviews Lot and
assigns a disposition
Warehouse or Shop floor Laboratory QA / QC
Company Confidential – LabVantage Solutions, Inc.
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General Workflow - Stability
Stability Protocol
defined in LIMS
Stability Protocol
Approved and Study
created using protocol
Physical Samples held
in quarantine until
study start date
Time Zero Sample
tested. Remaining
Samples stored in
appropriate conditions
Pull Samples and print
Sample labels at the
appropriate time
points
Sample Receipt, Data
Entry and Approval
activities
Quality Release Activity
Stability Manager
reviews study data
Study is complete,
reports are printed
Study Initiation Study Execution Study Completion
Company Confidential – LabVantage Solutions, Inc.
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Connecting to LabVantage Pharma
http://hostname/WebApplicationName
Currently supports Edge, Chrome, and Safari as the browser
Runs on PC, Mac, Apple and Android hand-held devices
Other browsers may be added in the future such as Firefox (currently not supported)
Company Confidential – LabVantage Solutions, Inc.
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Signing On
UserName – User name assigned to you by your Administrator
Password – Provided by Administrator
Database – Select from the dropdown the proper Database if necessary
Provide your unique
Credentials
“Forgot Password”
request is
available
You might have
production, validation,
training, etcetera
A maximum number of
invalid sign-on attempts
will be enforced
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Understanding the Site Map
Once connected, you can navigate through LabVantage using a variety of Site Maps, Tram Lines, Tram Stops,
Menus, Buttons and other Tools
Menu
Picker
Site Map
Tram Stops
Tram Lines
Side Bar
Tabs and
Menus
Company Confidential – LabVantage Solutions, Inc.
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Links and Profile Menu
1. Profile Menu options are located in the top-right corner of pages within LabVantage. The Help, Search,
Bulletins, and Menu Picker links are accessible on
all pages.
2. It is necessary to Log Off in order
to properly end your session.
Closing the browser without
logging off can, in some cases,
result in a denial
of service to other users.
Company Confidential – LabVantage Solutions, Inc.
Bulletins
Menu Picker
Search LabVantage
Help
Logoff
Change Password
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Bulletins
Your number of unread Bulletins shows on the envelope link
Use the buttons to send a new bulletin,
mark them as read or unread, delete, or
close and return to the site map
Details can be viewed by clicking a bulletin
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Tool Bar Buttons
Buttons appear in the toolbar or ribbon located across the top of pages and perform a
defined operation when clicked
Some buttons will be
presented similar to
menu selections
through drop-lists
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Hot Keys
Some keyboard shortcuts are assigned to the tool bar buttons. Some are preconfigured by
LabVantage and others can be defined by your administrator. The shortcut is activated by
holding CTRL plus the character(s) defined.
To see a specific short-cut, hover the mouse over the button on the tool bar.
Typically these shortcuts will make use of some [Ctrl] + [Shift] + letter combination.
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Search
Use the search options to filter the list and reduce the number of records on your screen
Keyword
Search
Filter using some
criteria
Advanced Search
Calendar
View
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Advanced Search
Appears to the left when activated
Scan an ID. Click Add for
multiple.
Filter Using Categories
Create and use Folders
Create and search by
Ad Hoc Queries
Select listed items
using a scanner
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The Side Bar
The Side Bar is on the left side of pages. Click on any item to activate.
Hide entire bar [ << ]
Click to manage your sidebar
(shown)
Hide this section
Click to change your sidebar view
You can create a new
sidebar or modify an
existing one to give
yourself a tailored list of
favorite shortcuts.
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Different Types of Pages
List, Maintenance, and View pages
List Page
View Page
Maintenance
Page
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Record Locking
When a user accesses a record to edit (maintenance), it becomes locked. This prevents
multiple simultaneous edit attempts from different users .
The sample can still be ‘viewed’ by others while it is locked for editing.
Locked by [user one].
Click to send a message
User one is Editing User two attempts to edit the
same sample
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What is the Navigator?
Navigator is a generic way to view objects in a hierarchical tree view. It is shown as a tree
structure allowing you to drill down to various nodes and to illustrate parent/child
relationships.
There are 9 Navigators within
LabVantage. Some of them are:
• Quality Management
Navigator
• Request Navigator
• ReagentLot Navigator
• Stability Study Navigator by
Condition
See notes on this page for
additional navigators
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Navigating the Navigator
Use the drop-list in the navigation panel to access other pages. The maintenance page on
the right will change with the node selected on the left.
Highlight
words in the
tree
Return to
Previous Page
View Available
Options
Collapse
subordinate
nodes
Expand all
subordinate
nodes
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Time Out
Logging out is a decision made by a user to end their LabVantage session
Timing out occurs after an extended period of inactivity within your session. Timing out
will give you a 2 minute countdown. If you do not click Continue, you are disconnected and
shown the login page.
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Departmental Security Concept
Who can view (or perform operations on) an SDI, depends on ownership and departmental
membership.
Sample S-001
Owner = Jim
Department = QC
Sample S-002
Owner = QC
Department = QC
Sample S-003
Owner = Sally
Department = R&D
Sample S-004
Owner = (none)
Department = (none)
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Electronic Signatures
Some changes to records will require your
electronic signature. This comes in the form of a
prompt for your password (e-Sig) and the reason
for the change.
Other changes may only require a reason, without
requiring an e-Sig.
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Audit History
The ‘View Audit” link is found under Other Tasks in the toolbar . Clicking on ‘View Audit’
will open the audit report for the selected record
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Translating the Interface
LabVantage provides a translation tool to enable multiple, simultaneous language
translations. An example is shown here where some of the tabs, menus, and side bar options
have been translated into Spanish. Your administrator will create languages and choose your
language for you or may allow you to select a language using your profile settings.
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Summary / Conclusion
Let’s review what we’ve leaned so far:
General information about LabVantage: how it is built and how it works
Users within LabVantage: licenses, roles, how to access your database
Site Maps, Buttons, Tool Bars, Hot Keys, Pages
Search Bar, Side Bar and Queries, Bulletins and Notes
Time-Out and Log-Out
Navigator Tool
Data Security, eSignatures (eSig), Record Locking, Audits
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Exercise: Accessing LabVantage
Access the training database and sign in
Set your Startup Page to the LIMS site map
Try out some Bulletins
Browse the help system
Log out of LabVantage
Editor's Notes
101-v87_01_Overview.pptx R01
Please share your level of involvement with LabVantage or other LIMS products and your background in this industry with the rest of the class. Use this space to record contact
information about your classmates (with their permission).
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
This slide shows the overview of our 3-day training session. The detailed daily agenda will be shown at the start of each day.
Overview: What is LabVantage and How does it work; User Roles and Access; Accessing LabVantage; Understanding the layout and features of LabVantage.
Site Maps: Three site maps; what each contains and how they are used.
Master Data: How is LabVantage structured; Parameters, Tests, Products, Materials, & Specifications.
Sample Life Cycle: What is a Sample; Sample Log-in; Managing Samples; Data Entry; Release and Approval; Sample Disposal.
Performing Searches: Queries and Searches; Ad Hoc Queries; Textual Searches.
Reporting: Reporting Tools and Outputs.
Batches: Analytical Quality Management; Analytical Quality Control; Batch Management.
Request Management: Grouping of Common Samples.
Consumables: Overview of the Consumables Module (i.e. consumable management, using recipes).
Physical Storage: Storage Locations; Moving Samples in/out of Storage.
Instruments & Analysts: Tracking Instrument & Analyst Certifications; Instrument Calibrations.
Summary: Review; Putting it all together.
Vantage Care & Next Steps: Post-training Resources; Other Training Course considerations.
LIMS is a Laboratory Information Management System used to track and retrieve sample information, such as:
Tests performed
Results of the tests
Specifications used
Manufacturing data
And More!
Sample progress is tracked from receipt until all testing is complete
LabVantage LIMS makes use of the following technologies (among others) to present data to you:
AJAX (asynchronous JavaScript and XML) is a group of interrelated web development methods used on the client-side to create interactive web applications.
JSP (Java Server Pages) Java technology that helps software developers serve dynamically generated web pages based on HTML, XML, or other document types.
SQL (Structured Query Language) is a database computer language designed for managing data in relational database management systems (RDBMS). Its scope includes data query and update, schema creation and modification, and data access control. It is the most widely used language for databases today.
Groovy is an object-oriented programming language for the Java platform. It is a dynamic language with features similar to those of Python, Ruby, Perl, and Smalltalk. It can be used as a scripting language for the Java Platform.
Through a simple and intuitive spreadsheet style interface, LabVantage Stability allows you to automate:
Shelf-life Sample generation based on specified times and number of product pulls for each study
Label creation based upon scheduled pull dates
Calculation of the required number of containers to start a stability study
And much more!
An operational challenge for many laboratories is the management, maintenance, and tracking of laboratory instruments and consumables.
Instruments and Reagents in LabVantage:
Define different types of instruments and consumables
Identify which type of consumable and instrument is required for each test method or control
Construct a recipe for "mixing" a known amount of a reagent
Supports re-calibration and expiration dates
And much more!
LabVantage Batch Management permits the definition of a testing optimization strategy so that the lab need not perform all tests on all Samples of every batch. LabVantage supports both Skip Lot and Reduced Testing strategies, providing the utmost in flexibility to match your standard procedures.
LabVantage offers a variety of mechanisms for grouping, tracking, and viewing Samples. Designed for use in multi-site and multi-language settings, LabVantage enables collaborative research efforts across far-ranging physical & cultural boundaries. Fully satisfying 21 CFR Part 11 regulations, LabVantage provides all of the security, auditing, authentication and approval controls necessary to attain compliance.
Three Tiered Application
Client Layer – A browser on PC, Mac, iPhone, Android, or device server
Application Layer – Jboss, WebSphere or WebLogic
Database Layer – Oracle or Microsoft
Reports server – many options available
LabVantage Recommends Red Hat JBoss EAP 7.3 (for LV8.7).
JBoss Enterprise Application Platform is the leading open source platform for next-generation JavaEE applications. Built on open standards, JBoss Enterprise Application Platform enhances JBoss Application Server with enterprise features and leading open source frameworks to provide a complete solution for Java applications.
http://docs.redhat.com/docs/en-US/JBoss_Enterprise_Application_Platform/index.html
Other Supported Application Servers:
Oracle WebLogic 12.1.2
IBM WebSphere 8.5.5.11 or 9.0.0.11
End-user clients communicate with the web server using standard HTTP requests via a request controller servlet, which manages all requests by redirecting control to the appropriate service. Services may be authentication requests, web pages, attachment downloads, reports or other atomic operations, such as Asynchronous JavaScript and XML (AJAX) requests. Pure HTML LabVantage web pages are generated using Java Server Pages (JSPs). LabVantage custom tags and Java APIs facilitate the generation process by communicating directly with the LabVantage application server
Batches or Products will both be the primary device for Sample creation. They will contain pre-defined testing schemas and specifications limits per the product Specification.
Logging activities are controlled by Roles and Departments. Users must have the correct combination of access and view properties to perform Sample creation.
Creation of the Batch may be accomplished by Raw Materials QC Receiving or by Manufacturing / Planning.
Creation of the Batch and receipt of the Stages will occur at the same time. Receipt of the Samples will be left to the individual labs via the Sample Receipt page.
At the time of Batch creation, or when known, any associated Raw Material or Intermediate Batches will be linked to the Finished Goods Batch through the Associated Batch feature. The disposition of the Finished Goods Batch can be restricted in LIMS until all associated batches have been dispositioned.
A Sample Label Report may be created which will contain information directly from the LIMS batch in order to assist the lab personnel in processing the Samples.
Sample Receipt will be utilized to record the receipt date of the Samples in each individual lab. This will allow metrics to be gathered regarding the time between batch creation and the initiation of testing activities.
Reduced testing for approved vendors may be achieved using the product variant and sampling plan levels.
All data entry for the testing of a batch will reside in LIMS. Lab notebooks and/or additional documentation used for assistance during testing may be referenced as parameter values.
Approval roles will be defined to allow peer approval in addition to manager approval.
Stability Studies will be created in LIMS per material protocols and SOPS. The creation, initiation, approval, and management of Stability Studies will be controlled by security.
Stability reports will be created to support the day to day processing of the various Stability Study elements such as stability study creation (Stability Template Report), Sample pull dates (Pull List Report) and summary data reporting (Stability Summary/Matrix report).
A Stability Sample Label report will be created to assist in managing the delivery of Stability Samples to the various testing labs
Data entry for Stability Samples will take place in the labs, with final review still residing with the Stability Manager.
LabVantage’s LIMS helps laboratories increase productivity, lower operating costs, and improve quality. It is able to do this through its Configurable Process, Automation, and Communication capabilities. LabVantage Pharma allows you to access the application using nothing more than a browser. Both the Application Server and the Database need to be running in order to connect to the application.
Requires the most current browser for that version (see the SaphCoreInstall.chm file under Sapphire Prerequisites for platform requirements for your specific version.)
Connects via a URL http://hostname:80/applicationName
http:- Hyper Text Transfer Protocol (http), the communications protocol that enables web browsing
hostname – Application Server Name
80 – Optional port used for the Web App to communicate with the Server. Different installations may use different port numbers
WebApplicationName – During the LabVantage installation, you will give a name to your Web Application. This name will allow you to access the Web App via the URL.
Username and password are not case sensitive by default. These can be made case-sensitive by your administrator.
Your access will be "disabled" after three unsuccessful logon attempts. You can be "enabled" by the System Administrator in SystemAdmin Users. If username is “disabled”, you must contact your system administrator. Only the Administrator can set it back to ‘Enabled’.
If you’ve forgotten your password, click the “Forgot your password?” link. You will be asked to provide your user name and email address. An email confirming that you’ve requested a new password will be sent to the email address you’ve provided, with a “Reset” action button. You will then receive a 2nd email with your new, temporary password. Remember to change the temporary password when you next sign in to LabVantage.
Access to LabVantage is allowed based on the number of active licenses your organization holds. When the number of available licenses are in use, any new users attempting to log-in will be denied access until such time as another user logs out and frees up a license.
The drop-list of available databases is populated by the ADMIN database. This database retains a list of all installed LabVantage database names.
Once you have successfully logged in, you are presented with a ‘Site Map’. The three Site Maps are called Lab Admin, System Admin and LIMS. Each Site Map will display only the Tram Lines and Tram Stops assigned to your role by your System Administrator. The Site Map may be accessed at any point by clicking on the Menu Picker located at the top right of the page in the Menu Bar.
The Side Bar is an expandable, collapsible, and configurable set of links. It displays links to pages you elect to show through options available in the cog wheel.
Tram Lines (modules) and Tram Stops (pages or actions within the modules) are visual representations of the tabs located across the top of each page. Clicking on a Tram Stop will open a new page within LabVantage.
Tabs are a standardized series of Menus which mimic the relevant Site Map, Tram Lines, and Tram Stops. They will only list the Menus that the user is able to access based on their security and assigned roles within Lab.
The Breadcrumb Bar is directly beneath the top Menu Bar. This has two modes: Recent History and Related items. If you choose Recent History, as you navigate through the application, your last 6 recent items are shown. Clicking any of these takes you back to them. The list of recent items is unique for each tab (or window). The title for the current page is shown in black at the end of the Recent Items. Collapsing the window resolution collapses from the left, so the current page is always shown. As you navigate using the Top Menu and Full Page Menu, the Related Items shows other items that are in the same sub-Menu (and are therefore related). The current page title is shown in black on the left, and the current Menu loaded into the page is highlighted. As the window resolution collapses, the Related Items collapse from the right.
Some common Buttons are accessible on every page:
Menu Picker allows you to exit your current page, returning to the Site Map or to navigate to a different Site Map.
Bulletins (see next page).
Search LabVantage is covered in the chapter on searching.
Help opens a page that allows you to access the help file and search, view topics, or print the help.
Logoff ends your session and frees up a license for another user. It is recommended that you log off at the end of each of your sessions. Logoff will bring you back to the login screen, ready to log into your next session.
In addition to the above list, the following buttons are accessible through the drop-selector in the top right:
Change Profile Picture makes it fun and easy to see who is currently connected on this computer.
Change (User) Preferences allows you to adjust your contact information and some default settings including Business Objects integration.
Change Password allows you to change your password
Set as Start-up Page allows you to designate the page you wish to see upon log-in, normally the page used most often.
Show Hidden Records allows users with the appropriate security and roles to view records no longer visible to general users.
Add Page to Sidebar will create a link to your current page as an item in the left-hand side bar.
Edit [Page] will allow you to change the functionality of the current page assuming you have a license for LabVantage’s Web Page Designer suite.
Bulletins are informative messages you can send to other LabVantage Users or to groups of users with the same Role(s) and/or Department(s). You can configure the system to send bulletins automatically, or you can send them personally through this page. A user preference allows you to decide if you would like to receive these messages in your email inbox.
To view new Bulletins, click on the envelope. After reading, you can close or delete the bulletin. To mark the bulletin as read or unread, select the bulletin and click the down arrow on the Bulletins button, then click the appropriate button.
To send a Bulletin to an individual or group(s), click the Send New button. You can make your messages a high priority and provide a URL link to a web page.
Example of sending a new bulletin:
The buttons appearing across the tool bar will vary from page to page depending upon the activities related to the page and, the roles of each end-user
The Tool Bar Buttons are groups of buttons arranged into logical groups within a Tool Bar. The Tool Bar is a combination of symbols and text.
The above Tool Bar is for the Sample Receipt page.
You may notice that LabVantage will automatically adjust the number of displayed buttons according to your screen size. As your screen size or window size is reduced, buttons will be grouped as sub-buttons for use.
Hot keys are not available for all styles of buttons or buttons in a detail panel.
Button hot key combinations can be redefined for you by your administrator.
The Search Element executes queries to populate or filter a List page. You can click a query which might execute without any additional input from you, or you might need to provide some search criteria.
Keyword search will match records found in the ID or Description columns of this list page.
These options and functionality are covered in detail in the “Performing Searches” portion of this course. The Advanced Search bar can be collapsed to give you more on-screen work space.
Advanced Search Options:
Scan in IDs searches for an exact ID or IDs on the list page. Barcode Scanning searches for an exact ID or IDs on the list page.
Folders and Categories are additional ways to filter the list page. These are all different ways to find what you need on a list.
Adhoc Search
LabVantage Adhoc Query tools provide an interface to build and execute SDI-centric queries without using SQL. Queries are generated by Red Hat Hibernate, a Java open source object-relational persistence and query tool. LabVantage dynamically generates object-relational mappings according to the data model. At runtime, Hibernate Query Language (HQL) is generated from the search criteria. Hibernate then generates SQL script using the corresponding database dialect.
The Sidebar allows a collection of Gizmos to be displayed. The Sidebar lists the Gizmos and allows different operations to be performed when the Gizmo is selected (such as navigation or processing logic). Like the Menu Bar Gizmos, the Sidebar Gizmos can also show counter information. There are several display versions of the sidebars (such as large icons, small icons, and text only) that can be configured in the GUI Policy or for the Group Gizmos LINK themselves. You can switch Sidebars by selecting the Cog wheel at the top of the Sidebar. The Sidebar can also be resized and collapsed and on mobile touch devices, revealed with a swipe. The Sidebar is vertically responsive (if the vertical space reduces, a scrollbar is shown when you hover over the Sidebar).
If you have the correct permissions and the Group Gizmo can be customized, you can dynamically add and remove Gizmos to your Sidebar. Add Gizmos by selecting "Add Gizmo" in the Cog menu. You can then select from configured Gizmos to which you have access. Selecting Gizmos pushes them to the end of your Sidebar. To change the order of the Sidebar Gizmos, select "Unlock Sidebar" from the Cog menu. You can then drag-and-drop the Gizmos into position. To remove a Gizmo, drag it off the Sidebar and confirm in the confirmation dialog. When finished rearranging, you can select "Lock Sidebar" to set the positions. You can also use "Reset Sidebar" to reset back to administrator defaults.
LabVantage contains List Pages, Maintenance pages and other types that allow you to view and maintain data in the database. It is through these pages that LabVantage allows you to safely populate, update and delete data from the LabVantage database. The different page types define what you are able to do with the information on a page.
List Pages are indexed lists with a toolbar letting you add, view, copy, or delete database records depending on your role. Generally, a click on a tram stop from the site map will open a List Page. A list page retrieves rows from the database.
Maintenance Pages let you alter database information. They are used to add and edit existing database information, and enter information as you add new records. To open a maintenance page, select one or more rows by clicking the check boxes next to those rows, then click Edit. You might also click Add. To open the maintenance page for just one record at a time, click the blue hyperlink and the maintenance page will open. Clicking anywhere on a row, other than the check-box, will clear the previous selection and allow you to select edit, view, delete, etc. for the new selection. List and Maintenance pages have a toolbar with operation buttons. They also often have a side bar and a search bar.
View Pages let you view all information captured against a record. Edits are not permitted on a view page. Select your sample by clicking the check-box beside the Sample ID or, by clicking anywhere on the sample row, other than the blue hyperlink. Then click View to open a popup view page in a separate window for the one record. To view more than one record at a time, select the required records by clicking the check-box beside each Sample ID and click the View button on the tool bar ribbon.
Depending on how a record is accessed, a lock could be placed on the record and its details. For example, when a sample is being edited, no test results for that sample can be entered. The data is in 'view only' mode for all other users until the user making the edits saves their changes and exits the maintenance page.
Note: If test results are being entered “by test”, then the other tests for the same sample will remain unlocked.
If you hover your mouse pointer over the red padlock, the userid of the person who placed the lock is revealed.
Each link, tab, or button has a ‘Lock Property’. A locked record is shown with a red lock beside the edit fields. This is a "Yes/No" flag property to specify that any data on the page should (no) or should not be released (yes) when the link is selected. Using the Web Page Designer, your administrator can adjust this property. This property defaults to "Yes".
To release a lock, the person editing the record must save their changes and exit the maintenance page. Pop-up windows which open from the list page and allow editing will also lock the record which is released when the pop-up is closed. In the event a user “forgets” they have selected and therefore locked a record, your administrator can override the lock by forcing a user off the system.
The lock will also automatically release after 20 minutes of inactivity, again freeing up the record for another user.
Navigators are accessible through the ellipsis button which is seen at the far right side of the list page’s toolbar. Select a record and then click on the appropriate navigator to observe the layout. You may not have all / any navigators attached to your pages as they are role dependant.
Some navigators apply only to additional licensed modules. Other navigators you might find throughout the LabVantage application:
Biobanking Sample Navigator
BioBanking Study Navigator
CAPA Incident Navigator
Stability Study Navigator by Timepoint
StorageUnit Navigator
View Available Options: Shows you a list of available actions for each node. Upon selection of Edit, View, Data Entry or View Results Attributes, the appropriate maintenance page will open in the right panel of the page. This allows you to perform the required action without having to exit and return to the sample list page.
Click on a different sample or use the up/down arrow to select the desired node and open the default operation page in the panel on the right side of the page.
Don’t forget to Save your edits before exiting Navigator!
Time Out occurs when you leave your LabVantage session idle for too long . This will close your session and release your license. If this happens, you will automatically be prompted to log back in. Any data entered, but not yet saved, will be lost.
The default timeout period is one hour. This can be adjusted by the Administrator. Logging out will bring you back to the main login page.
The timeout dialog contains a "Continue" button that can be used to keep the connection alive."Continue" updates the last updated date for the connection and restarts the countdown from the set connection timeout. Closing the dialog (x) or pressing the Esc key does the same. The timeout dialog contains a "Log Off" button, which stops the countdown and forces logoff. This disables both the application and the dialog, automatically logs you off, and loads the Login page.
When multiple browser windows are open, a mechanism causes the server to initialize and synchronize the timeout dialog in each window (as long as they are using the Sapphire JavaScript Global API). Clicking "Continue" or "Log Off" in any window causes the other windows to react to this change when the next connection check is activated. Note that this could be as long as 20 seconds after the dialog opens. When time-to-timeout reaches 0, all windows load the login page. As with multiple windows, tabs are also synchronized if they are in the same session, i.e., using the same ConnectionId. The timeout dialog loads in all frames that share the connection that is timing out. When time-to-timeout reaches 0, all tabs are directed back to the login page.
Departmental Security is based on ownership of an SDI. What you can do with the SDI (the "SDC Operation") depends on who owns it. Both Users and Departments can own SDIs. We'll look at this by example. Assume these starting conditions:
"Jim" owns Sample "S-001".
The "QC" Department owns Sample "S-002".
The "SDC Operation" available for the Sample SDC is "view" (meaning view the Sample in read-only mode).
Jim can view "S-001", and all members of "QC" can view "S-002".
Since Jim is a member of "QC", and "QC" owns "S-002", Jim can view "S-002".
All Users in all Departments can view S-004 (no restrictions).
If Jim is also a member of R&D, he can view S-003. If Sally is not a member of QC, she can only view S-003 and S-004.
If your organization requires compliance with FDA guideline 21 CFR Part 11 for trustworthy electronic records, e-Sig can be set to require your user id/password and the reason for the change to the record.
However, if you are not working in a regulatory environment but you still wish to track changes for audit or other internal checks, e-Sig rules can be changed by the Systems Admin to the following options:
Suppress the password requirement for reauthorization while still requiring a reason to be entered
Suppress e-Sig if Adding vs Editing
Suppress e-Sig based on user activity. For example, a user changing a result may be required to provide an e-Sig but the same user may not have to provide an e-Sig when adding a new test or assigning an analyst, depending upon their role.
If you fail to supply the correct password, you will be prompted again. Data is not saved until you supply the correct password. If you supply the incorrect password four times, your account will be disabled and you are immediately disconnected from LIMS and the entered data is not saved. An administrator will need to re-enable your account.
There is also the option of suppressing e-Sig completely.
Quoted from the US Code 21 of Federal Regulations:§ 11.50 Signature manifestations.(a) Signed electronic records shall contain information associated with the signing that clearly indicates all of the following: (1) The printed name of the signer;(2) The date and time when the signature was executed; and(3) The meaning (such as review, approval, responsibility, or authorship) associated with the signature.
Auditing is a built-in, automated procedures within LabVantage that records all changes made to each SDI that is added to an SDC. Each change is a revision that is tracked by a sequential numbering system referred to as an Audit Sequence. The resulting Audit Table is an historical account of all the activity within each SDI.
Usually only a manager or QA is interested in the audit report.
Auditing may also be viewed from within Data Entry:
Display the Detail Tab to view the Audit History of the sample selected.
Auditing may be turned on or off by your administrator for each type of record. For example, Samples might have auditing enabled whereas Locations may not.
Caution - Audit tables can grow large and might be difficult to read, which is why access is normally restricted to only a few users with a very specific need for this information.
Virtually every word or phrase including buttons, error messages, and even data can be translated to a different language. Here are some details and caveats:
Coming up…
The Site Maps
Master Data
Sample Life Cycle
Day 2:
Performing Searches
Batches: AQM, AQC, Sample Grouping
Request Management
Day 3:
Instruments & Analysts
Reagents and Standards
Stability
Workflows
Conclusion
This exercise will give you some time to become accustomed to the LabVantage end-user interface. Your instructor will provide you with a URL, username, password, and database to use for these exercises. It is important that you use the same connection information for this and all future exercises.
Logging into LabVantage will be a frequent occurrence. Short-cuts are easier than the extra step of opening a browser for each log-in.
It is important to change your assigned password when you first log into to LabVantage and to keep your password secure. As many organizations have password change policies, you’ll need to know how to change your password within LabVantage.
LabVantage comes with an extensive help system. The topics are searchable and offer examples to help you understand how to make use of the product features.
Logging out of LabVantage is also important to keep your account secure and to free up your concurrent user license for the next person who may need to sign into the application.
"Timeout" is an event that automatically clears a connection. Sixty (60) seconds after you login or load a page, a connection check is conducted. The connection check returns:
Time-to-timeout: Time remaining until timeout.
Interval: Time between connection checks.
If your administrator has enabled this time-out feature, you may be automatically logged out if you exceed a maximum number of idle minutes during your session.