21 CFR Part 820 outlines the current good manufacturing practice (CGMP) guidelines for developing medical devices. It governs the methods, facilities and controls used for medical device design, manufacture, packaging, labeling, storage, installation and service.
QSR compliance is easier and more effective when quality is part of the business culture. Download these free resources to learn how to infuse quality into the organization.
The MasterControl Quality Excellence solution integrates all quality processes. Unify document control, training, change control, corrective and preventive action (CAPA), customer complaints and audit management. Also, automate design control and reduce the time and effort involved in maintaining your design history file (DHF).
Connected
Control every aspect of quality from a single platform. This helps you avoid mishaps and other issues that can cause costly delays and setbacks.
Consistent
With MasterControl, you improve communication, unify business units and make better use of time and resources.
Complete
Maintain all documentation, including the design control process and design history file (DHF) contents, in a single location. This gives you confidence that documents are complete, accurate, up to date and easy to locate during an audit.
Compliant
A solid quality infrastructure enables you to overcome challenges along the regulatory pathway. Meet every milestone and goal toward compliance and market success.
21 CFR Part 820 establishes the basic requirements for manufacturers of finished medical devices. It is designed to ensure devices are safe and effective and comply with the Federal Food, Drug and Cosmetic Act (FD&C Act).
Gain a competitive edge with the MasterControl Quality Excellence solution. Automate all quality processes. Comply with 21 CFR Part 820 requirements faster and get to market sooner.
Complies with subparts C, D, E, G by offering a real-time view of the quality system for continuous monitoring and improvement. MasterControl automates design control processes, which helps ensure your design history file (DHF) is complete and accurate. With this approach to maintaining the DHF you have a complete record of the design that's always available. This makes it easier to demonstrate that you followed the approved design plan, which can prevent possible product recalls.
Complies with subpart B, section 820.25 by automating the management of all training processes. Easily route, follow-up and escalate training. Provide online exams, allow group sign off and automate sequencing of training tasks.
Complies with subpart B, section 820.70 by automating every step in the change control processes. Achieve faster turnaround times. Customizable reports show real-time status of change control tasks and the entire quality system.
Complies with subparts I, J by automating all CAPA processes. It integrates with other quality processes, such as document control, change control and audit. Allows for a holistic approach to quality management.
Complies with subpart B, section 820.22 by automating all audit processes. Simplify audit preparation, scheduling, issues, verification and completion. Reduces the time and effort needed to pass an audit.
Complies with Subpart M, section 820.198 by streamlining different steps and combining multiple sources of complaints under a single platform. It provides a configurable form that captures all necessary information and provides automatic follow-up notification to ensure timely responses.
Complies with subpart I, section 820.90. It automates processes set up to identify, evaluate, review and handle nonconforming materials. This includes all components, parts and finished products.
Easily meet QSR requirements, improve efficiency and keep compliance costs down.
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