Issued by the FDA, 21 CFR Part 820 lays a foundation of Current Good Manufacturing Practice (CGMP) regulations that delineate the processes involved in designing, manufacturing, packaging, labeling, storing, installing and servicing finished medical devices intended for use by humans. The 21 CFR Part 820 software solutions offered by MasterControl Inc. are expressly designed to streamline and enhance medical device development while sustaining regulatory compliance.
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At all times during the development process of a medical device, project managers routinely stumble upon significant obstacles such as regulatory constraints, limited resources, and timely delivery of finished products. Regulatory requirements such as 21 CFR Part 820, otherwise known as the Quality System Regulation (QSR), outline elements which, while intended to ensure product quality and safety, may often be viewed as contributing factors to such stumbling blocks. As mentioned above, the FDA 21 CFR Part 820 guidelines are intended to clearly define the regulation of quality systems related to the methods used in and the facilities and controls used for design, purchasing, manufacturing, packaging, labeling, storing, installing, and servicing of a medical device. Effective 21 CFR Part 820 software solutions can help companies subject to intensive regulatory guidelines by automating, simplifying, and streamlining the processes mentioned above.
MasterControl's integrated, user-friendly 21 CFR Part 820 software solutions are specifically engineered to meet the demands of companies doing business in demanding business environments that must comply with strict medical device development regulations. MasterControl's 21 CFR Part 820 software allows companies to overcome device development challenges by automating and connecting project management processes. The efficient task assignment and robust reporting capabilities provided by MasterControl's proven system can help project managers accelerate and simplify project execution and better identify and eliminate bottlenecks. It effectively manages and connects quality processes to allow continuous monitoring and improvement of quality systems.
MasterControl integrates document and quality management with project management systems to help companies efficiently utilize and manage resources, maintain compliance with regulatory requirements, and get products to market according to schedule. By handling the legwork of document management and task tracking, MasterControl 21 CFR Part 820 software makes it possible for project leads to focus on the technical components of projects rather than the administrative aspects.
MasterControl also integrates corrective action processes with other quality processes to ensure 21 CFR Part 820 compliance. For instance, a corrective action and preventive action (CAPA) form can be launched directly from another form (such as a nonconformance report). The 21 CFR Part 820 software system then directly enters relevant data into a CAPA form, thereby reducing data entry and eliminating errors that may otherwise occur during the manual transfer of such information. Because the system is web-based, customers, vendors, and other authorized parties outside the company can submit forms (such as customer complaints) that could potentially lead to a CAPA. The entire quality management life cycle can be monitored through the 21 CFR Part 820 software system's customizable reporting capabilities.
MasterControl provides advanced analytics and reporting features that offer a real time view of the quality system which is compliant to FDA 21 CFR Part 820. The 21 CFR Part 820 software system's filtering and project "baselining" features make it possible for development teams to view tasks by category and monitor the evolution and expansion of ongoing projects. Project workflows are dramatically streamlined as tasks are automatically updated and electronically managed by MasterControl's comprehensive 21 CFR Part 820 software system.
To learn more about how MasterControl's 21 CFR Part 820 software can facilitate your company's medical device development processes, contact a MasterControl expert by calling toll free at 800-825-9117.