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

Extension of xEVMPD Sending NEW

It is now possible to send xEVMPD messages on the packaging level! That means, the updated data model implemented in the October 2017 Release can now be fully used to send xEVMPD messages to the EMA. To reduce time and clicks when sending data, you can select multiple data-sets and then validate and send these to the EMA in one process.

New Business Object: Medical Device Application NEW

You can now track product information for Medical Device Applications within drugTrack! The new business object also contains a full life-cycle module (Regulatory Activities and Change Control Management) which means you can track the whole life-cycle of your Medical Device Applications with LORENZ drugTrack.

New History Concept NEW

All Regulatory Activity objects in drugTrack (Marketing Authorisations, Development Products, Medical Device Applications) are now versioned and have a history. This enables you to do a full life-cycle management of Regulatory Activities. In addition, the 4-Eye Approval is now available for all Regulatory Activities and ensures the internal validation of entered data.

Extension of Instant Reporting Functionality NEW

It is now possible to do a full export of table content in the Details Pane. The Excel export contains all information found in a specific table, even if that table contains another sub-table. With this you are able to export all the data you need within seconds!

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.