To understand the importance of online quality management software in regulated environments, one has to grasp the concept of quality control. W. Edwards Deming, the world-famous proponent of quality control, believed that quality should be incorporated at the start of the manufacturing process, instead of inspecting products for defects at the end.
Deming helped Japan turn around its post-World War II economy by helping Japanese manufacturers produce high-quality products that dominated the global market. The application of Deming's concept of quality eventually spread from general manufacturing to life science and other regulated industries. He has greatly influenced the prevalent concept of quality management system (QMS) today, as well as the use of online quality management software and online QMS in regulated industries.
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Deming famously said that "quality is everyone's responsibility." In the life science industry, quality is incorporated in the entire development and manufacturing process, making it everyone's concern. Using online quality management software and establishing a QMS make it easier to connect all stakeholders so quality becomes everybody's business.
The U.S. FDA's regulations and guidelines for the life science industry reflect the importance of quality management in keeping medicines, medical devices, and other regulated products safe and effective. In particular, the FDA's Quality System Regulation (21 CFR 820) for medical devices outlines what constitutes an effective quality system. Medical device and other FDA-regulated companies were among the first to utilize online quality management software as the platform for their online QMS.
The FDA's 21 CFR 211 requires pharmaceutical companies to establish a quality control unit, whose major responsibility is to ensure quality in all facets of the manufacturing process. A quality management system, whether it's manual or online, is the quality control unit's responsibility. If a pharmaceutical company decides to use online quality management software, then the unit typically spearheads the effort to purchase the system.
ISO 13485 for medical device manufacturers and the ISO 9000 series for general manufacturers emphasize the importance of an effective quality management system. Online quality management software that exists in the market today is largely based on those ISO standards, in addition to FDA and other regulations.
ISO 13485 requires the establishment of a QMS that covers quality and remedial procedures. Similarly the ISO 9000 series requires the establishment of a QMS, including documentation of quality processes. Manufacturers are increasingly switching from paper-based or hybrid systems to online QMS.
MasterControl's online quality management software is widely used in life science and other regulated industries. Its enduring appeal lies in its fundamental characteristics - it is easy to use, configurable, and all applications are built on a common web-based platform. Users attest that the software is easy to implement and easy to validate.
For companies that prefer to use individual modules, consider the following MasterControl modules:
Please feel free to contact a MasterControl representative about questions you may have about online quality management software.