What is it?What's new?CompareEVMPD / IDMPTechnical Specifications
What's new?

Notification Extensions for Marketing Authorizations NEW

Enhancements have been made to drugTrack´s Warnings and Notifications for Marketing Authorizations. These workflow extensions allow users to reschedule, reassign, approve, forward and reject the records, as well as add other team members to the list of notified persons.

Create your own Configurable Business Objects NEW

If you have more specific requirements, we now offer you the ability to create customer-defined configurable business objects, as well as the option to add additional value lists that are not part of drugTrack’s standard configuration.

Example of a potential use case:
You would like to keep track of all Marketing Authorizations that contain ingredients sourced from animals. In addition, you want to track their species and subspecies. First you create three new configurable business objects which you label ´Animal Source´, ´Species´, and ´Subspecies´. You can then define your own attributes for the ´Species´ and ´Subspecies´ objects. Afterwards, you can add ´Species´ and ´Subspecies´ as drop-down items (configured fields) under ´Animal Source´. Once this new business object has been created, you can add it to your Marketing Authorization through an additional configured field.

Master File Tracking NEW

There is a completely new module available: Drug Master Files (DMFs) in the US or Active Substance Master Files (ASMFs) in Europe can now be tracked in drugTrack. In addition, this new object has its own Regulatory Activities and Change Control Management functions.

Extended List of Standard Reports NEW

To make your life easier, drugTrack now offers additional pre-defined standard reports. No need to program reports yourself, a selection of detailed reports is already available for you.

Other 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.