Small Medical Device Companies Can Now Manage and Automate their Design Control Process to Ensure Compliance with 21 CFR Part 820 with the Help of MasterControl's Design Control Software Systems at a Low Monthly Cost
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.
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 Organizers 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.
Die Schulung von Systemadministratoren ist zeitaufwendig und kostspielig. Mit guten Designlenkungssystemen können Sie diese Herausforderung aber ganz einfach bewältigen. Außerdem müssen Sie einen Mitarbeiter bestimmen, der diese Rolle übernimmt, oder einen neuen Mitarbeiter einstellen, der sich um die Systemadministration kümmert.
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.
Summary of Features of our Design Control Software
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:
Design Revision Control: MasterControl's design control systems provide automatic document revision control to ensure that only the current version of a standard operating procedure SOP is available. When a user makes a change in the InfoCard (the MasterControl tool that provides basic information for every electronic document), the user must enter a reason for the change. The software tracks all changes made to the InfoCard.
Design Control Changes: Solid Audit Trail: The design control software provides a secure, time-stamped audit trail exceeding 21 CFR part 11 requirements. MasterControl documents the identity of anyone who creates or modifies an electronic record, when the action occurred, and the changes made.
Design Control Security: 21 CFR Part 11 emphasizes security practices that limit access to authorized users and holding them accountable for written policies. With MasterControl, an electronic document is stored in virtual vaults located in a central database for access by authorized users only. The software automatically locks both login and approval anytime either one is compromised.
Design Documents - Advanced Tracking: MasterControl's electronic design control system tracks documents by status or history. A document will show as either in process or complete, if tracked by status. The revision or approval history of electronic documents can also be reviewed using the history feature.
Analytics and Reporting on Design Control Processes: MasterControl's electronic design control system uses advanced analytics and reporting capabilities in the form of standard and customized reports to help increase management oversight.
Electronic Sign-offs: With MasterControl's design control software, electronic documents can be signed and approved in an automated fashion. Electronic signature manifestation, name, date, time, and meaning of electronic signature, can be appended automatically to each document.
Manage Different Document Types: MasterControl's electronic document management system is uniquely qualified to be the focal point of any compliance initiative because it can manage different documents-based processes and handle all types of electronic documents regardless of the software used to create them.
Easy Access: MasterControl's design control software is web-based so it can connect all employees involved in document and quality control from virtually anywhere. Provides a centralized repository for easy access, search, and retrieval of electronic documents by all authorized users.
Automates Routing, Escalation, Approval: Reduces document cycle time by automating routing and approval and incorporating escalation for overdue tasks.
Dependent Routing: Completion of a task can be made dependent on another task to give managers more control and reduce cycle time by prompting users immediately to their next task.
Streamlines Collaboration: Creating and revising documents as a team is easier because MasterControl's design control system provides a collaboration workspace that allows a user to see other people's input, avoiding duplication. A rejected document is automatically returned to the originator for a new task, so rejected packets don't languish in the system.
Integrates with Other Applications: MasterControl's electronic document management system can integrate with other applications like ERP, LIMS, accounting, and human resources applications to accommodate departmental needs.
Pre-Defined Workflow: Company-wide policies, SOPs, and other electronic documents that require inter-departmental collaboration move along a pre-defined workflow, from one department to the next. Overdue tasks automatically escalate to a manager by the design control systems.
Automation of Forms-Based Processes: Form processes unique to a department (i.e., application forms for HR, customer satisfaction survey forms for Customer Service Department) can be integrated with document-based processes under one secure repository in the design control sofware. A department can keep the look and function of existing forms or create entirely new ones.
Easy to Search: A standardized Google-like search window is available throughout the application, which means all authorized users throughout the organization can search for tasks, training records, policies, and other documents using a familiar search interface.
Easy to Find: MasterControl's Organizer, similar to Windows Explorer, is an easy-to-use tool that helps users find and access documents quickly within the design control system. Every department can maintain its own Organizers and documents can be stored in multiple Organizers. System administrators can control and automatically update the documents through a dynamic link in the InfoCard.
To Learn about Design Control Software Systems
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.
MasterControl Inc. and its partner, i4DM, are expanding their FDA project, serving as the QMS providers for a second FDA division. The two companies have been the QMS providers for the FDA's Office of Regulatory Affairs since 2009. Now they will also serve as quality providers for the Division of Pharmaceutical Analysis, which is part of the FDA's Center for Drug Evaluation and Research.