21 CFR Part 820
Quality System Regulation QSR Requirements for Medical Device Manufacturers for 21 CFR Part 820 Compliance
FDA 21 CFR Part 820, also known as the Quality System Regulation QSR outlines Current Good Manufacturing Practice CGMP regulations that govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. These requirements are meant to ensure that medical devices are safe and effective. Medical device manufacturers undergo FDA inspections to ensure QSR compliance.
The MasterControl™ quality management suite is an integrated, configurable, and easy-to-use software solution especially designed to facilitate compliance with 21 CFR Part 820 and other FDA regulations. Here's how MasterControl can help medical device companies meet key QSR requirements and at the same time increase efficiency and keep compliance costs down:
| QSR / 21 CFR Part 820 Requirements |
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MasterControl Integrated Quality Suite Features |
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Require controls in design, document, purchase, and production process. This entails establishment of processes to ensure that a medical device conforms to specifications. Requirements emphasize maintenance of records of document changes, documentation of instructions of production processes and SOPs, and monitoring of process parameters.
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MasterControl Documents™, the building block within the MasterControl quality suite, automates and streamlines controls. It effectively manages and connects quality processes to allow continuous monitoring and improvement of the quality system. It offers advanced routing, approval, escalation, and revision control. Provides advanced analytics and reporting capability for a real-time view of the quality system.
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Each manufacturer must have sufficient personnel with the necessary background, training, and experience. It must have established procedures for identifying training needs and ensuring that employees are adequately trained to perform their jobs. Training should be documented.
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MasterControl Training™ automates assignment and monitoring of training tasks and grading of online exams. Allows sequencing of training courses, so after a prerequisite is completed, the next course is automatically launched. Provides group sign-off feature for verifying training of large groups of employees.
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Production and process changes: Each manufacturer shall establish and maintain procedures for changes to a specification, method, process, or procedure. Such changes shall be verified, or where appropriate, validated - before implementation and these activities shall be documented.
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MasterControl Change Control™ streamlines the entire change management procedure for faster turnaround. It offers a best-practice form that incorporates priority level and prompts risk assessment and classification of the change as low, medium, or high. Any high-level change is likely to require regulatory filing. Customizable reports provide real-time status of change control tasks and the entire QS.
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Require establishment and maintenance of nonconformance and corrective and preventive action (CAPA) procedures. Nonconformances relating to product, processes, and quality system should be investigated. Actions needed to correct and prevent recurrence must be identified. Corrective action has to be validated to ensure effectiveness. All activities pertaining to nonconformance and CAPA must be documented.
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MasterControl CAPA™ integrates corrective action process with other quality processes. A CAPA form can be launched directly from another form (i.e., a nonconformance report). Automatically enters relevant data into a CAPA form, reducing data entry and eliminating errors from manual transfer of information. Through the Internet, customers and vendors outside the company can submit customer complaint or other forms that could lead to CAPA. Provides customizable reporting capabilities to help managers monitor entire quality management life cycle.
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Appropriate controls over system documentation including access to documentation for system operation and revision and change control procedures that documents time-based system modification.
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MasterControl Audit™ automates, streamlines, and effectively manages the audit process. Provides advanced tracking capability, from scheduling and planning to execution and completion. Offers best practice forms for tracking basic audit information and audit findings. Automates scheduling of all recurring audit-related activities and provides analytics and reporting capability for Increased Management Visability.
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Each manufacturer shall maintain complaint files-establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit.
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MasterControl Customer Complaints™ streamlines the complaint-handling process and reduces the lifecycle from submission to resolution. A simple, three-step process is incorporated in a pre-configured, multi-page form that starts with processing of a complaint, moving to internal investigation, and culminating with issue resolution. Includes the FDA's MedWatch 3500A form for mandatory reporting of adverse events, allowing a seamless handover to an adverse events specialist while ensuring that required data is immediately collected.
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( 21 CFR Part 820 Subpart, Sec. 820.90)
Requires medical device manufacturers to establish and maintain procedures to control product that does not conform to specified requirements. The disposition of the nonconforming product must be documented.
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MasterControl Nonconformance™ is designed to automate, manage, and streamline the process for identifying, evaluating, reviewing, and handling of nonconforming materials, components, parts, and finished products. The solution's best-practice form and five-step process connect all responsible personnel for effective and timely disposition of a nonconformance.
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MasterControl is compliant, helping you meet 21 CFR Part 11 and other FDA regulations year after year, while keeping compliance costs down.
MasterControl is connected, giving you the ability to monitor the entire quality system and continuously improve it.
MasterControl is complete, meeting every department's needs to ensure that quality initiatives are enforced across the enterprise.
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