SALT LAKE CITY – June 19, 2007– MasterControl Inc., the leading provider of GxP process and document management software solutions for the life science industry, today announced the availability of MasterControl DHF JumpStart™, a solution for collecting, organizing, and reviewing all the documents required to meet FDA requirements. The software is specifically created for automating the design control process at a price affordable for startup and small-sized 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 JumpStart meets all these requirements.?
With DHF JumpStart, 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 JumpStart include:
- ASP Model: MasterControl DHF JumpStart 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 JumpStart affordable for small companies who are not ready for a full-scale document control system.
- 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.
- 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: 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.
- Turnkey Solution: MasterControl DHF JumpStart 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.
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.