Change is inevitable. This inevitability is the reason why regulated companies are required to establish control measures that will ensure the efficacy and safety of their products and services in spite of changes. Change control procedures apply to many areas in manufacturing, including design, components, labeling, and packaging. It is particularly critical in the engineering process. Increasingly, medical device and other manufacturers are relying on engineering change control software as the basis for their engineering change control systems.
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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).
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.
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:
To learn more about MasterControl solutions, visit a MasterControl online. or call toll free at 1.800.825.9117 to speak with a representative.