GlobalTrack

GlobalTrack is an enterprise planning and tracking tool built specifically for Life Sciences using the widely adopted Microsoft SharePoint platform. Enterprise customers benefit from the native features of Microsoft SharePoint and the industry specific expertise and capabilities delivered by Mission3.

GlobalTrack is a business intelligence platform that provides Life Sciences companies increased visibility into their global regulatory initiatives. Its features include the following:

• Collaborative project planning tool for submissions for all regions, including creation of project tasks / milestones, resource delegation and granular content planning for each submission
• Automated registration tracking, including progress tracking for ongoing submissions and real-time access to registration statuses for all products
• Storage and management of agency interactions worldwide
• On-demand reports and interactive visuals to analyze key performance indicators used to measure operational effectiveness
• Seamless integration with existing information systems - ERP databases, document repositories, submission publishing tools and others

Plan

Using GlobalTrack, Life Sciences companies can plan all registrations and associated content for product portfolios that are marketed globally.

GlobalTrack is designed to reduce overall content development time-lines, control issues related to global registrations, and easily manage renewal time-frames and cadence.

• Gantt, Time-line, and task based planning
• Plan products, registrations and associated content and documents
• View all global registration plans individually or in context
• Import Microsoft Project plans
• Save project plans as templates to ensure knowledge and best practices are captured
• Standardized international registration and renewal requirements company-wide

Manage

Before GlobalTrack, it was impossible to completely manage regulatory aspects of product portfolios from a single system.

GlobalTrack provides control over managing products, documents, submissions, and regulatory correspondence even if the data and activity of these artifacts resides on disparate systems.

GlobalTrack brings order, context, and timeliness, and control to activities generally managed by tools that lack real intelligence.

• Associate documents from eDMS systems with submission and product plans
• Manage global regulatory correspondence against products and submissions
• Compare global regulatory correspondence in a timeline view against other regulatory activity
• Associate documents and submissions to get a global "where-used" perspective of your content
• Unify metadata across your disparate systems to eliminate confusion
• Connect data from disconnected systems to reduce data entry

Report

GlobalTrack provides complete Regulatory Business Intelligence, meaning all of your questions can be answered through in-depth reporting and ability to "slice and dice" data to find exactly what you are looking for.

Whether through real-time visual dashboards or exportable formal reports, GlobalTrack provides the most comprehensive and tailored Business Intelligence in the industry.

GlobalTrack reports on data from across your enterprise systems, giving you a complete view of all regulatory activity without the need for error-prone, manual data entry.

• Dozens of prebuilt reports which can be configured, saved, and exported
• User-selectable dashboards that show the information relevant to you
• Real-time reports that let you immediately find the information that you re looking for
• Make better decisions with better data without distracting busy regulatory team members
• Easily extend the reporting capabilities of GlobalTrack using standard Microsoft SharePoint-based reporting technologies
• View global activity from a single system

Implement

Since GlobalTrack is based on Microsoft SharePoint 2010, it is the easiest and most well-understood enterprise Regulatory Information Management system to implement and integrate into your environment.

Mission3 has extended Microsoft SharePoint's native Business Connectivity Services to support cohesive integration between systems and normalize data across your enterprise.

GlobalTrack is designed to support Life Science Regulatory Information Management and can be rapidly and completely validated.

• Utilizes native SharePoint security and enterprise integration functionality
• Out-of-the-box connectors for a variety of eDMS, Submission Publishing, ERP, and Clinical systems
• 21 CFR-Part 11 compliant solution built specifically for Life Sciences
• SharePoint-based system ensures GlobalTrack can be maintained and extended by internal IT and other service providers
• Supports several languages for global deployment
• Eliminates the need to implement proprietary, silo'd, third party systems

Benefits of GlobalTrack

The need for staying on top of registration information is driven by the value of knowing exactly what product is registered where and having a good grasp on ongoing regulatory interactions and upcoming milestones. This information is critical for planning product launches and ensuring the continued sustenance of successful products throughout their life cycles. Most Life Sciences companies, however, struggle to compile and communicate this information to decision-makers efficiently. Supporting data is stored in disparate repositories and ad-hoc formats being managed by different regulatory teams around the world. Thus most tracking and reporting efforts are highly labor-intensive and costly, and a significant source of frustration for execution teams and executives alike. Mission3 has technology capabilities and the best business practices for companies to bear in mind as they cope with the dynamics and challenges of managing regulatory expectations in a global setting.