MasterControl today announced it will release MasterControl Registrations™, MasterControl Registrations™ for eCTD and MasterControl eTMF Manager™ along with its next update to MasterControl QMS version 11.7 later this fall.
The three new MasterControl cloud solutions are in keeping with MasterControl's long-term vision as an organization. "MasterControl has been offering the advantages of EQMS solutions in the cloud for more than 10 years. We are excited to put this experience and know-how to work in helping our clients tackle compliance challenges in the regulatory and clinical departments with these new solutions," said Matt Lowe, executive vice president.
The new solutions can deliver life science companies noticeable ROI by helping regulatory and submissions professionals and clinical managers dramatically improve process efficiencies and accelerate time to market.
- MasterControl Registrations - for medical device and discrete manufacturing firms: A dossier management and product registration solution that provides project visibility by region and product. For each device, users will readily see all geographic locations where the product is being registered and the corresponding requirements. Inversely, users will easily see all products and corresponding artifacts that are up for approval or re-registration in every geographic location.
"The typical regulatory manager is juggling multiple projects in multiple phases and collecting documents from many different sources across departments. These projects are then customized across markets. This level of automation accelerates products to market and really shows a fast and sustainable ROI to a company's bottom line," said Alex Butler, manager of medical device solutions, who leads the team responsible for the development of this new offering.
- MasterControl Registrations for eCTD - for pharmaceutical, biologics, and biotechnology companies: The Electronic Common Technical Document (eCTD) is the standard format for submitting applications, amendments, supplements, and reports for pharmaceutical and biologic products to the FDA and other global regulatory agencies. MasterControl Registrations for eCTD allows tracking of all submission requirements per geographic location where a product is being registered. It streamlines content generation and management in preparation for electronic submission publishing via a partner or in-house publishing tool.
- MasterControl eTMF Manager: The electronic trial master file (eTMF) management solution provides users engaged in clinical trials a standardized management tool that provides real-time visibility into the status of all activities related to their clinical studies. This solution was designed in accordance with the latest version of the TMF Reference Model by the Drug Information Association's (DIA) TMF Working Group.
"With the eTMF Manager, we're giving clinical operations a means of organizing their clinical trial documentation in a standardized way that facilitates oversight, management and compliance while still using convenient tools they're already familiar with," said Patricia Santos-Serrao, director of pharmaceutical and biologics solutions. "This solution helps manage the TMF lifecycle from beginning to end and can save time and money by significantly reducing silos, increasing efficiency and improving communication, sharing of information to relevant internal and external parties and maintaining and ongoing inspection readiness state."
