MasterControl DHF Express - Design Control Software
MasterControl DHF Express Introduces Design Control Software to Help Medical Device Companies Manage and Automate the Design Control Process to Ensure Compliance with 21 CFR Part 820
Each manufactured medical device must be supported by appropriate document design control software which demonstrates that its development followed the Food and Drug Administration's (FDA) design control guidelines. MasterControl's DHF Express was established for each device to house this documentation for the FDA.
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How Can MasterControl DHF Express Prove to be the Right Design Control Software for You?
MasterControl DHF Express provides a design control software 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.
Here's how MasterControl DHF Express addresses some of the major challenges that medical device companies face in controlling documentation to meet FDA requirements:
|Design Control Software Challenges||MasterControl DHF Express 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 process may cause critical delays in product development which can be resolved with MasterControl's DHF Express design control software.
MasterControl DHF Express 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.
It is easy to review all documentation at each phase of production by using design control software. If the Design History File (DHF) is incomplete, resources are wasted while searching for the required documentation.
|Electronic DHF Express
Using MasterControl Organizers, industry best practices, and regulatory guidelines, MasterControl's DHF Express is configured to swiftly provide documents as needed, whether for a design review or FDA inspection.
|New Product Delay
Design control software 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 Express 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 Issues
Training system administrators is time consuming and costly. It also means you must designate an employee to specialize in this role or hire a new employee to assume the system administration function which is not required in implementing design control software.
| Minimal Training
System administrator training is unnecessary. MasterControl DHF Express is ready out-of-the-box, requiring minimal user training. MasterControl's system administrators attend to any system needs.
Summary of Features of MasterControl DHF Express - Design Control Software:
MasterControl DHF Express 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.
Below is a summary of its key features and benefits:
- 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 design control software 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 DHF Express includes dashboard and drill-down features.
- Automated Routing, Escalation, and Approval: Design control software 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 preconfigured 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.
- 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 design control software 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 design control 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 DHF Express consist of an 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 DHF Express 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.
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