What is it?What's new?FeaturesEVMPD/IDMP
What's new?

Health Authority Commitment Tracking NEW

The Commitment object has been added for Marketing Authorisations. This feature allows for the tracking of various commitments made to Health Authorities, e.g. Post Approval or Post Marketing commitments. It has its own value lists, including milestones with respective status effects and fields to link each commitment to the Marketing Authorisations and/or Regulatory Activities which triggered it. It is also possible to include links to the Regulatory Activities and Change Control Management records that were created to address a specific commitment.

Standard System Reports NEW

Several pre-defined system reports are now available in the drugTrack Advanced Reporting module, which can be used to report on certain use cases.

Extended Volume Edit Functionality NEW

drugTrack now offers a ´Volume Replace´ functionality that allows you to select several records and select certain information in tables to be either replaced or deleted. This new functionality allows for more complex use-cases to be performed with just a few clicks, and also now allows you to batch edit records in a much more precise manner.

Dashboard Gadget: Bookmarks NEW

A new gadget has been added to the drugTrack dashboard – Bookmarks. By selecting it, you can create a list of hyperlinks on your dashboard. This can be used to save any hyperlink, e.g. docuBridge webAccess links, drugTrack links or links to guidance documents on agency websites.

xEVMPD: Re-submission Recommendation NEW

drugTrack now checks whether changes done to a record necessitate a resubmission to the EMA and will flag those records accordingly. The drugTrack Scheduler Service will run through the database at regular intervals and compare the XML used in the previously sent xEVMPD message with the current XML message, in order to find and flag any changes in the records which would necessitate a resubmission of a data record.

Separate Customer Configuration NEW

drugTrack has enabled the configuration of field properties using the LORENZ adminPanel. In the new area “Business Object Fields”, each single business object field in the system can be displayed. You can also select an entry to open the Details Pane for more detailed information. It is also possible to customize field labels, hide fields or make them mandatory, or to add additional configured fields to certain objects.

Highlights

Enhanced Grid Searches in the Browser Client

It is now possible to search for underlying objects immediately from the higher level object. Within marketing authorizations, you are now able to search for and filter by substances or other criteria.

Editing EVMPD Data in a Browser Client

The browser client is now capable of editing and validating all information in a marketing authorization. This enables the managing of all EVMPD-relevant changes in the new web client.

Receiving the EMA 3rd ACK Messages with the Desktop Client

The desktop client has been enhanced in order to receive 3rd ACK messages coming from the EMA, as a quality review of EVMPD messages. The scheduler service has also been extended to support this task.

Prepare to be Stunned: A Brand-New Web User Interface!

LORENZ drugTrack 5 now boasts a brand-new web user view client. Based on feedback from user interviews, the new client was consciously designed to provide an enhanced user experience. When working with the new client, you will notice that Navigation within your Product and Regulatory Information is greatly improved. With drugTrack 5 you can find the required data directly and can seamlessly navigate through your data. If you didn´t know, you wouldn´t think it was a web interface!

Create "Ad-hoc" Reports

drugTrack provides advanced filter functionality. With this feature you can find answers to questions directly in the tool, create a print friendly view or export it to Microsoft Excel for further processing

Structured Detail Information

drugTrack now provides a new configurable layout that allows you to display detailed product information in a structured format. The new Details Scroll-bar allows you to jump directly to the area of interest and new Tabs provide additional layout options. In addition, companies can configure a Summary Page which includes all information relevant to their work-environments.

Controlled Vocabulary Updates

When complying to external standards that you do not control, such as the xEVMPD standard, you are faced with continuously changing vocabulary lists. With drugTrack, you can now automatically update these vocabulary lists. drugTrack will guide you through the entire update process, let you know which records may be affected (if any), and help you make alternative choices. There is no longer a need to be worried about changes you cannot control.

Improved Workflow through Related Submissions

Some registrations are connected. For example, if you use Mutual Recognition procedures to register your product then you can now create a group of selected registrations and share data between them.

Easy Data Comparison

You can now highlight all changes made within one marketing authorisation very quick and easy. Time consuming comparisons between the older and the newer version of one marketing authorisation is no longer needed. The marked entries tell you what has changed between the versions.

Email Notifications

You want to have e-mail notifications of all the due dates from your regulatory lifecycle? You do not want to open the program every morning to see what tasks you have for today? With the new version of drugTrack you will receive an e-mail notifications for all marketing authorisations that need to be renewed, PSUR that have to be filed and all other actions with other due dates you have entered. So you will never forget what to do next to fulfil all your deadlines.

Security

An audit trail is available with the new version of drugTrack. Administrators can easily view and report on any changes within the user interface.

Dashboard

drugTrack now offers a dashboard with pre-configured filters which provide exportable information.

Clicking on a chart will open a Details Pane that displays the relevant information.