MakroCare has extensive experience working with big Pharma / Bio Pharma in maintaining their licenses globally. After noticing the gaps in process and workflow management between multiple stake holders in these type of engagements, MakroCare has developed an application, mTrack that is flexible and easily configurable with sponsors work flow. mTrack is helping project teams in supporting and tracking regulatory communication between internal and external stakeholders. mTrack also supports the teams on regulatory correspondence (between Sponsor Project team, Mfg site coordinators, third party vendors, local affiliates & MakroCare Project teams) and tracking of activities. This application has been very helpful for managing global regulatory engagements.
mTrack is a centralized, web-based system which is accessible through any browser. mTrack tracks and reports all the tasks to all the stakeholders (Sponsor project team, Sponsor project manager, MakroCare project team and MakroCare QC Team) in project and also provide a detailed daily summary sheet to Sponsor project Management and simplifies communication process.
This process follows:
mTrack also supports both the teams on regulatory correspondence (between Sponsor Project team, Sponsor Mfg site coordinators, Sponsor third party vendors, Sponsor local affiliates & MakroCare Project teams) and tracking of activities. This application has been very helpful for managing global regulatory engagements.
- mTrack keeps team members synchronized, increases accountability and ensures reliability of information
- Configurable workflows and reinforced process to enable all stakeholders track the project.
- When a task is assigned, an E-mail notification will be automatically sent to assignee containing a brief description and a URL link to the tasks record.
- Complete Audit trial
- User, role and group level permission to restrict access to content and actions at any level of the project
- Reports based on status, due date and time, responsible person and reports can be generated in XML/CSV format.
In an engagement of this complexity, mTrack avoids manual intervention and saves costs on project management and functional stakeholders’ hours. In addition to providing the ability to track the project in real time, this MakroCare developed innovation is expected to significantly save cost to Sponsor.