SALT LAKE CITY--(BUSINESS WIRE)--MasterControl, a leading global provider of enterprise software solutions that enable life science and other regulated companies to deliver life-improving products to more people sooner, 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.
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.
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 an ongoing inspection readiness state.”
MasterControl Inc. produces enterprise software solutions that enable life science and other regulated companies to deliver life-improving products to more people sooner. MasterControl’s integrated solutions securely manage a company's critical information throughout the entire product lifecycle while reducing overall costs and increasing internal efficiencies. More than 1,000 companies worldwide ranging from five employees to tens of thousands use MasterControl’s suite of scalable cloud solutions for document management, quality management, electronic batch record management, supplier management, and clinical and regulatory information management. MasterControl solutions are known for being easy to implement, easy to validate and easy to use. For more information, visit www.mastercontrol.com.