GlobalTrack

GlobalTrack provides Life Sciences companies with all the necessary information to track and manage their product portfolio in real-time. GlobalTrack integrates seamlessly with existing repositories to provide companies with a single source of truth for all their information and reporting needs, via a visually dynamic web-based interface.

If you have been faced with any of these challenges - GlobalTrack is the right fit for your enterprise:

• FTEs are taken off task to locate and aggregate information.
• Days are wasted while other critical work is neglected although deadlines do not change.
• Once you have it, tracking information is inaccurate or outdated.
• It is not possible to get an overview of what products from which division are registered or approved in which region or country.
• When was correspondence from an agency received and how did we react to it.
• What document was used in which submission or registration for these specific regions or countries.

GlobalTrack's powerful, yet user-friendly, submissions tracking tools help automate a process that has historically been labor intensive, error-prone and is generally considered a significant drag on the productivity of regulatory teams.

GlobalTrack's capabilities include:

• Registration Tracking - helps determine what products are registered in which region and when renewals are due.
• "Where-Used" Tracking - enforces change control by identifying all the submissions where a document is used.
• Correspondence Management - provides a clear audit trail of all regulatory interactions, artifacts and timelines.
• Dashboard and Gantt-based Reporting - enables users to create and export custom reports, on-demand by specifying multiple criteria including metadata.

Enterprise Integration

GlobalTrack is designed and proven to work within your existing enterprise systems. It leverages a standards-based API to interact seamlessly with content repositories, such as Documentum and SharePoint, in a highly secure manner without requiring any re-validation of the existing systems.

GlobalTrack Capabilities

GlobalTrack offers the following tracking and reporting capabilities:

Region and Country-specific Registration Status Tracking

GlobalTrack allows you to configure regions and countries where products are undergoing approvals and help track the progress of submissions in those markets. Some of the capabilities in this regard include:

• Tracking of important metrics such as % completeness and registration statuses by region and country across all products with information retrieved from disparate systems if necessary.
• Customizable reports and searching capabilities that allow you to filter by project and metadata fields, with results available real-time in conveniently downloadable formats as well as on your mobile device (e.g., using Mission3 iPhone App).

Clinical Trial and Regulatory Project Status Tracking

GlobalTrack's project management capabilities can be applied to your existing submission data as well as any content from non-regulatory domains (e.g., clinical, manufacturing) thereby integrating document management with project management in a single interface. The specific benefits include:

• Association of legacy content with specific project tasks including the ability to define timelines and duration, resource assignments and predecessor relationships. Essentially you have full access to Mission3’s Project Management module.
• Access to the Dashboard and Gantt-based Reporting Capabilities mentioned below.

"Where Used" Tracking

The Where-Used feature helps identify the submissions, assemblies and project tasks that a given document was used. It indicates in which version the document was used, in which region, and specifically where the document was placed within a submission or assembly.

This capability serves as a valuable tool for document-level searching especially during the content creation and validation process.

Regulatory Correspondence and Activity tracking

GlobalTrack also provides a tool for managing regulatory interactions so you can be proactive in addressing any agency concerns and ensure a smoother approval process, which has the following benefits:

• A highly intuitive user interface that displays all external correspondence and activities in the submission system stacked in a neat time-line at the application or product level.
• Categorization of interactions by product, region and regulatory agency with a clear view of regulatory feedback, actions taken, resources involved and critical milestones.
• Ability to store documents attached to regulatory interactions.

Dashboard and Gantt-based Reporting Capabilities

GlobalTrack's Dashboard and Gantt-based reporting capabilities complement Mission3's Project Management tools that help define projects and set up tasks based on your program needs. Benefits include the following:

• Interactive, Gantt-based reporting interface that serves as a powerful visual tool for identifying start/end dates, durations and predecessor relationships in a single view.
• Project summaries (e.g., description, owner, start/end dates, metadata, etc.).
• Dashboard charts and reports that depict percent complete (planned vs actual), associated submission statuses, work distribution summary (assigned vs unassigned tasks), upcoming milestones, critical tasks list, delinquent resources.
• Ability to download/print all of the above reports.