Each manufactured medical device must be supported by appropriate documentation which demonstrates that its development followed the Food and Drug Administration's (FDA) design control guidelines. MasterControl offers design control software systems for the design history files (DHF) which are established for each device to house this documentation for the FDA.
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MasterControl DHF JumpStart provides a solution for collecting, organizing, and reviewing all the documents required to meet FDA requirements. A design control system is specifically created for automating the design control process at a price affordable for startup and small-sized medical device companies.
Here's how MasterControl DHF JumpStart addresses some of the major challenges that medical device companies face in controlling documentation to meet FDA requirements:
Design Control System Challenges
Design Control Software Solution
Communication breakdown is likely to occur in a paper-based system that consists of disconnected tools and processes. Missing a step in the design control system may cause critical delays in product development.
MasterControl DHF JumpStart is a good example of design control software which is an integrated solution that connects users, data, and processes in a centralized system. This connectivity vastly improves communication and efficiency, ensuring that goals and objectives are met and completed in a timely fashion.
All documentation is reviewed at each phase of production in a design control system. If the Design History File (DHF) is incomplete, resources are wasted while searching for the required documentation.
Using MasterControl Explorers available in the design control software, industry best practices, and regulatory guidelines, DHF JumpStart is configured to swiftly provide documents as needed, whether for a design review or FDA inspection.
New Product Delay:
Design control requires that key design documents be reviewed and approved by several individuals. Time spent waiting on this process can impede product launch to market.
MasterControl DHF JumpStart automates collaboration, routing, follow-up, escalation, and approval of important design control documentation, removing this as an obstacle of product launch. Using electronic signatures further accelerates the approval process and ensures regulatory compliance.
Training system administrators is time consuming and costly which can be easily overcome with the use of good design control systems. It also means you must designate an employee to specialize in this role or hire a new employee to assume the system administration function.
System administrator training is unnecessary. MasterControl's Design control software, DHF JumpStart is ready out-of-the-box, requiring minimal user training. MasterControl's system administrators attend to any system needs.
MasterControl DHF JumpStart is an ideal design control software solution for early stage medical device companies that need an out-of-the-box, preconfigured document control system based on best practices. Here are some of the features and benefits of implementing an electronic document management software solution:
Find more information on MasterControl's design control software systems, by giving a visit to MasterControl online or call toll free at 1.800.825.9117 to speak with a representative.