MasterControl DHF JumpStart™ - Design History File Management Software

Automate the Management of Your Design History Files with MasterControl DHF JumpStart Software

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 meets their desires, point for point.

How Can MasterControl DHF JumpStart Help You Manage Design History Files?

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 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 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
Design Review: 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: Using MasterControl Organizers, industry best practices, and regulatory guidelines, the DHF 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.		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.
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 delivery to market.		Faster Turn Around: 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.
Slow Installation and Training: Other document 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.

Summary of Features:

MasterControl DHF JumpStart is an ideal 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:

• 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 to improve efficiency and time-to-market.
• Best Practice Processes: The system is pre-configured based on industry best practices and design control guidelines. Users are able to create, collaborate, and route design documents without having to spend hours configuring the system.
• Continuous Validation: For FDA-regulated companies, MasterControl offers a "continuous validation" approach that dramatically cuts the time, pain, and cost involved in validation.
• Electronic Approval Signatures: The system allows documents to display for review, collaboration, and/or electronic approval, accelerating the approval process.
• Grows with Your Business :Familiarity with the pre-configured system will allow the customer's sysadmin to make changes to accommodate new processes and procedures. As the company grows, it 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.
• Web-based Platform: MasterControl is Web-based so it can connect all employees involved in the design process from virtually anywhere.
• Validation: 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 software upgrades easier, faster, and more cost effective.