Medical device companies need an out-of-the-box design control tool to help them organize the myriad of drawings, notes, collaborative pieces, reports, and other documents that are created during the design process. They want a tool that bridges the gap between design and manufacturing and provides project management, design control processes, and document control and approval. MasterControl DHF JumpStart is the right design history file management software which meets their desires, point for point.
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MasterControl DHF JumpStart is a tool for medical device developers who work in small- to medium-sized companies. It's a preconfigured document control database that helps development engineers swiftly organize their work so they spend less time with administrative duties and more time in development. The design history file management software provides multiple simple routes for collaboration, approval, and review and is an affordable solution for companies a pre-configured best practices design control process.
MasterControl offers a line of validation products and services addressing different levels of validation needs based on individual risk assessment. They are designed to allow "continuous validation" for FDA-regulated companies by making validation of design history file management software upgrades easier, faster, and more cost effective.
Here's how MasterControl DHF JumpStart addresses some of the major challenges that companies face in meeting FDA design control requirements:
| Design History File Management Challenges | MasterControl Design History File Management Solution | |
| Révision de la conception All documentation is reviewed at each phase of production. If the Design History File (DHF) is incomplete, resources are wasted while searching for the required documentation. | Electronic DHF JumpStart: Using MasterControl Explorers, industry best practices, and regulatory guidelines, the design history file management software is configured to swiftly provide documents as needed, whether for a design review or FDA inspection. | |
| Customization Delays: Smaller companies with tight deadlines rarely have time to work with software requiring full customization as staffing resources are typically not available but MasterControl's DHF JumpStart makes your life easy. | Preconfiguration Speeds Your Work: MasterControl DHF JumpStart is preconfigured to organize documents in a complete design history file ready for design review or FDA scrutiny. | |
| Lancement des nouveaux produits retardé Design control requires that key design documents be reviewed and approved by several individuals. Time spent waiting on this process can impede delivery to market. | Faster Turn Around: MasterControl design history file management software 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. | |
| Slow Installation and Training: Other design history file management software programs can take months to install, weeks for a system administrator to set up and many days for a user to learn. | Quick Start for Staff: DHF JumpStart is out-of-the-box software requiring minimal system administrator and user training that can be installed in a matter of days. LDAP integration is available, if desired. | |
MasterControl DHF JumpStart is an ideal design history file management software solution for growing medical device companies who need an out-of-the-box, pre-configured document control system based on best practices.
Below is a summary of its key features:
To learn more about DHF Jumpstart and how the system from MasterControl can help with your design history file management software needs, please feel free to contact a MasterControl representative.
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