FDA Regulations and Engineering Change Control Software
The FDA's Quality System Regulation (QSR) for medical device manufacturers contains what is, perhaps, the mostly widely known change control regulation today. Under the QSR, change control procedures apply to design, components (including software), labeling and packaging, device manufacturing processes, production equipment, manufacturing materials, and all associated documentation. If your company is looking for engineering change control software, be sure to choose a solution that addresses those areas.
QSR requires that change control procedures, including engineering change control systems, should incorporate review and assessment of the impact of any design and/or engineering change. In evaluating engineering change control solutions, choose a system that includes a mechanism for tracking all change requests and change orders. These systems typically include any or all of the following forms and documents: request for engineering action (REA), engineering change order (ECO), and engineering change notice (ECN).
ISO Standards and Engineering Change Control Software
Manufacturers throughout the world adhere to ISO standards primarily because more and more companies prefer suppliers and providers with ISO certification. ISO compliance provides a competitive edge for manufacturers. Both the ISO 9000 series and ISO 13485 emphasize the importance of change control, prompting many manufacturers to use engineering change control software to help them comply with ISO standards.
A wide range of manufacturers adhere to ISO 9001 standards, which require manufacturers to identify, record, review, verify, validate, and approve changes in design and development. A key advantage for manufacturers that have switched to electronic engineering change control systems is the capability to connect different aspects of change control, from identifying change and numbering change requests all the way to approval and validation of the change.
ISO 13485, a set of standards for medical device manufacturers, requires the control of product development. This covers engineering change control and should be addressed in your choice of software.
Specifically, Clause 7.3 of ISO 13485 includes design and development reviews, verifications, and validations of changes. Electronic engineering change control systems are more efficient in generating, routing, approving, verifying, and validating design and development changes.
Choosing the Right Engineering Change Control Software Solution
Manufacturers are aware that not all engineering change control systems are created equal. Increasingly, they are switching from paper-based or hybrid (combination paper and electronic) change control systems to fully automated systems.
MasterControl quality and compliance software helps companies throughout the world in adhering to FDA regulations, GMP requirements, ISO standards, EU directives, and other regulatory requirements. Regardless of the regulations or standards that your company complies with, the following MasterControl solution can serve as the centerpiece for engineering change control systems:
MasterControl Change Control™: This software solution has all the elements necessary for engineering change control systems, as well as for other aspects of quality control. Here are some of the benefits it offers:
- Automates Change Control Process for Faster Turnaround: Timely response is essential to change control and should be a consideration when establishing. engineering change control systems. MasterControl will help you achieve a faster turnaround by automating all aspects of change control, including routing, notification, follow-up, escalation, and approval.
- Integrates Training Control: Unlike other engineering change control software, MasterControl offers the capability to integrate training control with the change control process. Any change to a process or document that requires training will automatically invoke training tasks for all affected users.
- Best-Practice Forms to Help Ensure Compliance: MasterControl streamlines the entire change control process with the help of best-practice forms that incorporates priority level and escalations. A pre-configured form collects and tracks data throughout the entire change control process.
- Efficient Management of Product Spec Iterations: With MasterControl, engineering and product development teams will be able to manage the continuous flow of spec iterations. MasterControl automates the review and approval process, making collaboration among geographically dispersed teams faster and more effective. Unlike other engineering change control software, MasterControl allows design engineers to continue working in the CAD environments they are accustomed to, with the added benefit of streamlining workflows and processes.
- Centralized, Web-Based Location for Documents: MasterControl provides a centralized location for all design history files and technical dossiers. As a platform for engineering change control systems, MasterControl allows access to all authorized users 24/7 from virtually anywhere because it is web-based. It provides a virtual collaboration space for all team members regardless of where they are located.
- Makes Compliance Easier: As an engineering change control software solution, MasterControl offers out-of-the-box configurations based on industry best practices for compliance with ISO 9000 series, ISO 13485, and FDA's QSR requirements.
For More Information on MasterControl
To learn more about MasterControl solutions, visit a MasterControl online. or call toll free at 1.800.825.9117 to speak with a representative.
