Development
Design Control Management Software
Design Control is often mandatory for companies in regulated industries when they design and develop products. This should be a formal methodology or process to implement when working on product development projects.
Medical device development requires a large amount of documentation for demonstrating compliance with design control guidelines. When speed to market is critical, see how you can gain a significant advantage by automating your design history file (DHF) and document management processes.
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MasterControl DHF
Complete and accurate device planning, review, verification, validation, etc. documents are pivotal in building your DHF. MasterControl’s design control software is specifically designed to help you maintain a well-organized, error-free DHF.
Design Control Challenges |
MasterControl Design Control Software |
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Disconnected Processes Communication breakdowns that cause production errors and delays commonly occur with disconnected, paper-based design control processes. |
Connected Processes MasterControl’s integrated design control management software connects organizational units, data and processes. This vastly improves communication, production efficiency and your ability to stay on schedule with product releases. |
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Inadequate Document Management All documentation is reviewed at each phase of production in a design control system. Having to search for missing documents and artifacts is a waste of time and resources. |
Efficient Document Management With MasterControl, all documents and artifacts are stored and maintained in a centralized repository, allowing users to easily access, update and review materials, as well as provide a complete DHF during audits. |
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Slow Document Review Processes Design documents must be reviewed and approved by several stakeholders. Manually routing documents can delay production and product launch timelines. |
Streamlined Document Reviews MasterControl automates collaboration, routing, escalation, follow-up and approval of DHF documents. Using electronic signatures accelerates approval and regulatory compliance. |
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System Complexity Using disparate design control systems and processes can be complicated and require extensive training for configuration and system administration functions. |
Easy-to-Use Solutions MasterControl’s design control management software is ready to start using out of the box. It requires minimal user training, and MasterControl’s system administrators handle the system setup and configuration needs. |
Software as a Medical Device
Software continues to become more prevalent in medical devices. While software as a medical device (SaMD) provides increasing value to providers and patients, meeting the regulatory requirements for quality, safety and efficacy of evolving technology is a challenge. It’s important to have a design control system to easily manage the frequent changes with design and documentation.
Popular Design Control Software Features
MasterControl’s design control management software is the ideal design control system for medical device companies of any size.
- Document Revision Control Automatically track all changes to documents, and ensure that only the most current version of a document is accessible.
- Design Control Security Add another layer of security by limiting access of data and documents to only authorized users. Both login and approval processes are automatically locked if either are compromised.
- Time-Stamped Audit TrailDesign control regulations include guidelines around ensuring the security and trustworthiness of documents and records. MasterControl automatically tracks all design control processes, as well as document and metadata changes, including who makes changes and when.
- Collaboration Workspace Streamline document reviews and eliminate duplicated efforts using MasterControl’s centralized collaboration workspace. Multiple users can work on the same document anytime from anywhere in real time.
- Advanced Tracking Track documents by status (e.g., in process or complete) or history (e.g., revision or approval history). Immediately retrieve any documents needed during each stage of production.
- Electronic Signature Eliminate paper. Stakeholders can review and sign off documents electronically. Signature metadata (name, date, time, etc.) can be automatically appended to each document.
- Automated Routing, Escalation, Approval Reduce document cycle time by automating routing and approval, and incorporate escalation for overdue tasks.
- Multiple Document Types MasterControl seamlessly handles all types of electronic documents and other DHF artifacts regardless of the software used to create them.
- Analytics and Reporting Customize reports based on the specific needs of different stakeholders using MasterControl’s advanced analytics and reporting functionality. This helps with creating more granular documents for your DHF.
- Integrate With Other Applications Unify business units and processes. MasterControl’s system software seamlessly integrates with other applications, such as ERP, LIMS, accounting and human resources applications.
Ready for ISO 13485 Compliance
Automating your DHF and document management processes helps you achieve and maintain compliance with the requirements of ISO 13485, creating a faster pathway to more global markets.
ISO 13485 certification is not a requirement for regulatory approval. However, since the U.S. Food and Drug Administration (FDA) and other regulatory agencies worldwide started adopting the standard for quality management, compliance makes your organization audit-ready in more markets.
The QMS Provider for the FDA
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.
Need more information?
To learn more about MasterControl's software systems, please contact a MasterControl representative.
