Online Quality Management Software Systems (QMS)
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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Life Science Companies and Online Quality Management Software
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 Standards and Online Quality Management Software
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 Online Quality Management Software and Regulated Companies
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:
- MasterControl Documents: This module offers an essential capability for companies switching from a manual process to a fully electronic system. It automates routing, follow-up, escalation, and approval of SOPs and other critical documents. MasterControl is web-based so it is accessible to all authorized users from virtually anywhere 24/7. It provides robust document management features for any online QMS.
- MasterControl CAPA: This module automates and streamlines the CAPA process from start to finish. It offers industry best-practice forms that help reduce error in data entry. It gives users the capability to launch a CAPA form from another form, such as nonconformance or deviation.
- MasterControl Training: This module automates distribution and monitoring of training tasks, as well as online grading of tests. Unlike other online quality management software solutions, MasterControl Training has the capability to sequence training, so a trainee who completes a prerequisite course will automatically get the next training.
- MasterControl Change Control: Change control is a fundamental part of a compliant QMS. MasterControl provides a best-practice change control form that incorporates priority level, risk assessment, and classification of the change. The form can be launched directly from a CAPA form, connecting the change control process with CAPA.
- MasterControl Audit: A key advantage of MasterControl over other online software solutions is its capability to connect the audit management process with all critical quality processes. This module automates all audit-related tasks and schedules and provides robust tools for managing and conducting regular audits.
- MasterControl Mobile: MasterControl Mobile allows users to access documents, tasks, and processes via a tablet or a smartphone. Those users will be able to participate in documents - and forms-based processes quickly and conveniently. Mobile access will increase the "mileage" and utility of any existing QMS.
For More Information about Online Quality Management Software
Please feel free to contact a MasterControl representative about questions you may have about online quality management software.
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.
