Engineering change order software systems allow engineers to track the process of product development more easily than with a hybrid-electronic and paper-based system. Engineering change order software provides a structure for files outlining the full description, analysis, cost and impact of a change, and the names of people who are involved in making the change. A well-organized engineering change order software system can make it easy to track all changes made to a product and the date they occurred.
In medical device or pharmaceutical industries, a complete history of product changes is required and may be audited by the regulatory authority. Determining the root cause of a CAPA is much easier when the electronic document history is available.
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What happens without engineering change order software? Errors can be made that could lead to product recalls.
Here's an example. On Oct. 24, 2005, the FDA announced a voluntary recall of certain models of Omron instant thermometers because the thermometer tips could potentially overheat and pose risk to young children using the device. The FDA noted that the overheating was a result of a change in the manufacturing process. The agency's press release was brief and did not describe the circumstances of the change that caused the quality problem, but it illustrates the critical implications of change in the manufacture of medical devices in this case, or any other product for that matter. Whether it's a car or a computer or a pacemaker, the goal of regulatory bodies is to protect public safety by ensuring the highest quality standards. Change control and the need for engineering change order software are closely connected with FDA and ISO compliance.
Change control requirements for medical device companies are outlined in FDA's 21 CFR Part 820.30 (design changes), 820.40 (document changes), and 820.70 (production and process changes). 21 CFR Part 820 requires that manufacturers establish written change control procedures, which describe company-approved procedures.
For pharmaceutical companies, written procedures are considered part of Current Good Manufacturing Practice (CGMP) outlined in 21 CFR Part 210-211. Any changes in production and processes must be controlled - meaning recorded, reviewed, and approved by the quality control unit. CGMP requirements are meant to prevent harm by building quality into the development and production of medicines. Engineering change order software helps facilitate CGMP practices.
Manufacturers certified to ISO 9000:2000 and ISO 13485 standards are required to ensure that any changes affecting the quality management system (including product requirements, design, and development changes) should be controlled.
The underlying message in these regulations is that all changes should be made according to approved (approval implies successful testing or thorough review/investigation) written company policies and procedures. Change control procedures have to be written as a way of standardizing instructions. Written procedures are also more reliable compared with passing on information verbally. "Uncontrolled" change in this context refers to modifications made without review and approval of the quality control unit and other departments affected by the change.
In the FDA and ISO environments, strict adherence to approved policies and procedures is key in keeping manufacturing operations in a state of control and it is what makes change control crucial.
Engineering change order software systems are necessary to prevent inappropriate product modifications. A lack of documentation control can cause internal confusion, noncompliance and possibly a product recall or a product liability lawsuit.
MasterControl Change Control™ is a robust engineering change order system designed to simplify the change control process by automating and effectively managing every step of the way, from submission through actual implementation, verification, and close of project. Here's how MasterControl's powerful features address major challenges in change control:
To learn more about MasterControl's engineering change order software systems, contact a MasterControl representative.