Design Control Procedures

Automate Your Design Control Procedures to Improve Quality and Compliance

Automating design control procedures is critical for product quality and compliance. Add to that the regulatory environment in which medical device developers must comply with FDA's Quality System Regulation (QSR), and the task can seem insurmountable. Through the implementation of design control procedures, companies can become more efficient and improve product quality and compliance with global regulatory agencies.

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Converting a paper-based design control process to an electronic process may be challenging, but it ultimately helps eliminate common errors that could lead to serious regulatory problems.

How can MasterControl's Design Control Procedures Software Help 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:

• Design Revision Control: MasterControl provides automatic document revision control to ensure that only the current version of a standard operating procedure SOP is available and right design control procedures are implemented. 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: Software for design control procedures provide 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's design control procedures, 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 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.
• Analytics and Reporting on Design Control Processes: 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 according to design control procedures.
• 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 design control procedures and handle all types of electronic documents regardless of the software used to create them.
• Design Control Procedures for 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: 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 and predefined design control procedures 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 and design control procedures.
• 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.
• 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. A department can keep the look and function of existing forms or create entirely new ones according to design control procedures.
• 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 related to design control procedures. 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.

For More Information on Design Control Procedures

To learn more about design control procedures and change management software solutions, please contact a MasterControl representative.