MasterControl DHF Express Targeted at Growing Medical Device Companies
“There are roughly 15,000 medical device companies in the United States and 80 percent of them employ fewer than 50 people,” said Matt Lowe, medical device product manager for MasterControl. “But these small groups generate a tremendous amount of paperwork in the medical device design process. They need an electronic system that can manage all the design documentation they generate, at a price they can afford, from a vendor able to host the product and handle all the administration. MasterControl DHF Express meets all these requirements.”
With DHF Express, MasterControl aims to:
· Provide an integrated, out-of-the-box, preconfigured solution that connects users, data, and processes into a centralized system.
· Swiftly provide documents as needed, whether for a design review or FDA inspection.
· Automate collaboration, routing, follow-up, escalation, and approval of important design control documentation, removing this as an obstacle to product launch.
Key features of MasterControl DHF Express include: ASP Model: MasterControl DHF Express delivery model is ASP-based. The system is extremely easy to administer and can usually be installed in a matter of days. Affordable: The total cost of ownership is minimal because no special equipment is required. The ASP model makes DHF Express affordable for small companies who are looking for a system that will grow with them. Analytics and Reporting: MasterControl’s advanced analytics and reporting capability provides standard and customized reports. Design control documents can be summarized in multiple levels such as product, department, and document type. MasterControl includes dashboard and drill-down features. Automated Routing, Escalation, and Approval: Automates all design control document tasks, including routing, notification, follow-up, escalation, and approval. Automation helps sustain compliance by simplifying processes. Best Practice Processes: The system is pre-configured based on industry best practices and design control guidelines. Users are able to create, collaborate on, and route design documents without having to spend hours configuring the system.
Validation Flexibility: For FDA-regulated companies, MasterControl provides several flexible validation offerings and services to meet each company’s individual validation requirements. These offerings dramatically cut the time, pain, and cost involved in validation to ensure continuous compliance. Electronic Approval Signatures: The system allows documents to display for review, collaboration, and/or electronic approval, accelerating the approval process. Grows with Your Business: If required, MasterControl’s Professional Services staff can make changes to the preconfigured software to meet new requirements as a company proceeds through its growth cycle. More importantly, as the company grows, you can move into a full MasterControl system that can include training, CAPA, process automation, etc. without losing the efficiency of the preconfigured system or changes that may have been incorporated along the way. Organizers: MasterControl’s Organizer, similar to Windows Explorer, is an easy to use tool that helps users find and access documents quickly. DHFs are structured such that design reviews can be conducted entirely from within the DHF Organizer.
Part 11-Compliant Features: Provides time-stamped audit trail, reporting, and electronic signature capabilities that fully satisfy FDA’s 21 CFR Part 11 requirements. Security features include dual passwords for document approval; password expiration, encryption and certification; and account lockout to stop unauthorized users from gaining system access. Publishing: MasterControl offers automated conversion/publishing to PDF throughout the document lifecycle. Auto converting of documents to PDF reduces errors commonly associated with manual publishing. PDF conversion from multiple document types into a common, unalterable format helps improve efficiency and reduce costs by eliminating additional desktop software that would be required for users to view documents. Revision Control: Automatic revision control ensures that the history of the design is properly documented. Rights-based access to documents ensures that the most current, approved version of a document is being used. Turnkey Solution: MasterControl DHF Express is ready out-of-the-box. There is no special hardware to buy or system to configure. Data backup, antivirus protection and redundant hardware are all provided with minimal upfront costs. Web-based Platform: MasterControl is Web-based so it can connect all employees involved in the design process from virtually anywhere.
About MasterControl
MasterControl Inc. is a global provider of GxP process and document management software solutions for life science companies. The MasterControl™ suite is easy to use, easy to deploy, easy to validate, and easy to maintain. It incorporates industry best practices for automating and connecting every stage of the product development cycle, while facilitating regulatory compliance. By combining an integrated platform with a continuum of risk-based software validation products and services, MasterControl drives down the total cost of ownership and enables customers to extend their investment across the enterprise. Hundreds of companies worldwide use MasterControl for easier compliance, faster validation, and better process management. For more information, visit www.mastercontrol.com, or call 800-825-9117.