21 CFR Part 820 Software

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.

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.