Design Control

Automate Design Control Processes to Improve Efficiency and Ensure Compliance with FDA 21 CFR Part 820 QSR

Engineers must design, develop, and test new medical devices, and at the same time ensure that all of the necessary documentation is in place to demonstrate compliance with design controls. Find out how to reduce your documentation burdens during the design control process.

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How can MasterControl DHF for Design Control Benefit You?

MasterControl DHF and MasterControl Documents are an integrated part of the MasterControl's software suite that automates electronic document management and design control processes in an efficient and cost-effective manner. Here are some of the features and benefits of implementing an electronic document management software solution:

• Revision Control: MasterControl provides 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 design control software tracks all changes made to the InfoCard.
• Solid Audit Trail: 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.
• 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 design control software automatically locks both login and approval anytime either one is compromised.
• Advanced Tracking: MasterControl's electronic document management 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 wihtin the design control process.
• Analytics and Reporting: MasterControl's electronic document management 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, 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 in the design control process.
• Manage Different Document Types: MasterControl's electronic document management system is uniquely qualified to be the focal point of any compliance initiative of the design control 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 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: Due to the design control process, it 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 provides a collaboration workspace for design control 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. In a design control system, overdue tasks are automatically escalated to a manager.
• 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 design control processes under one secure repository. 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 design control tool that helps users find and access documents quickly. 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.

How Can MasterControl DHF Help Reduce Documentation in Design Control?

MasterControl DHF Express provides a design control 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.

Find Out More About Design Control by MasterControl

Find more information on MasterControl's design control software, by giving a visit to MasterControl online or call toll free at 1.800.825.9117 to speak with a representative.