The concept of total quality and quality management implementation took off in earnest after World War II, just as W. Edwards Deming was shaping a quality movement in Japan. Deming, a world-famous proponent of quality control, focused on improving all processes from the get-go instead of waiting for product inspection at the end of the manufacturing process. Deming’s concept has had a great impact on implementing quality management systems in the manufacturing world.
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In the pharmaceutical industry, there are two widely used documents that provide guidance for implementing quality management systems: Q10 Pharmaceutical Quality Management System and “Quality Systems Approach to Pharmaceutical CGMP Regulations.”
Q10 refers to “ICH Q10,” which describes a comprehensive model for an effective quality management system for the pharmaceutical industry based on ISO standards quality concepts. Q10 is considered a model system for quality management implementation and it can be implemented through the different stages of a product lifecycle.
Q10 gives a concrete framework for implementing quality management systems, including management responsibilities, continual improvement of process performance and product quality, and continual improvement of the QMS itself.
The FDA’s “Quality Systems Approach to Pharmaceutical CGMP Regulations” is a guidance designed to explain how manufacturers implementing quality management systems can comply with 21 CFR Part 211. The guidance defines quality concepts of a modern quality system, such as quality by design, risk management, CAPA, change control, and the six-system inspection unit.
For medical device manufacturers, the FDA’s 21 CFR 820 (Quality System Regulation or QSR) and 1SO 13485 are two of the most widely applied regulations and standards for implementing quality management systems.
21 CFR 820 identifies the essential elements of a good quality system, but it leaves manufacturers enough leeway to develop specific procedures for quality management implementation. The FDA’s Medical Device Quality Systems Manual also provides guidelines for implementing quality management systems and should be used by device firms in conjunction with QSR.
ISO 13485 outlines the requirements for device manufacturers in implementing quality management systems, including requirements pertaining to management, resources, remediation, and the quality system itself. For device manufacturers located in the U.S. or selling their products in the U.S., complying with both ISO 13485 and 21 CFR 820 is easier with the FDA’s harmonization of QSR with ISO standards.
MasterControl quality and compliance software has all the components that manufacturers need in implementing quality management systems, including document control, CAPA, audit management, change control, supplier management, and training control. In addition to providing software solutions, MasterControl offers the following services to facilitate quality management implementation:
Validation Services: MasterControl offers a full, front-to-back validation services and solutions—planning, protocol creation and definition of the project, systems configuration, risk management through customized validation testing and reporting—to make quality management implementation easier, faster, and cost-effective.
Cloud-Based Services: Implementing quality management systems doesn’t have to be prohibitive. For small and other companies concerned about the high cost of owning a QMS, MasterControl offers cloud-based services. A cloud-based QMS offers the same robust system in a secure environment without the need for a huge, up-front cost of, or a large IT staff.
Professional Services: MasterControl offers extensive consulting services to support customers in implementing quality management systems. The services include business process consulting and development, project management, best-practice consulting, and project integration management.
Education Services: To support customers’ quality management implementation efforts, MasterControl offers intensive training for system administrators, quality professionals, and other MasterControl users. The Education Services team conducts software training either at the customer’s facility or at MasterControl’s Salt Lake City headquarters.
MasterControl provides a complete solution to facilitate quality management implementation. To learn more about MasterControl, contact a MasterControl representative.