FDA 21 CFR Part 820

Quality System Regulation QSR Requirements for Medical Device Manufacturers for FDA 21 CFR 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 FDA 21 CFR 820 compliance.

Compliance with 21 CFR 820 and ISO 13485 Using MasterControl

Free Resources

Select all the resources you’re interested in downloading

The MasterControl quality management suite is an integrated, configurable, and easy-to-use software solution especially designed to facilitate compliance with FDA 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:

(FDA 21 CFR 820 Subparts C, D, E, G)

FDA 21 CFR Part 820 compliance 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.

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 which is compliant to FDA 21 CFR 820.

(FDA 21 CFR Part 820 Subpart B, Sec. 820.25)

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.

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.

(FDA 21 CFR 820 Subpart B, Sec. 820.70 )

Production and process changes according to FDA 21 CFR Part 820: 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.

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 FDA 21 CFR 820 regulatory filing. Customizable reports provide real-time status of change control tasks and the entire QS.

(FDA 21 CFR Part 820 Subparts I, J)

FDA 21 CFR 820 compliance requires establishment and maintenance of nonconformance and corrective and preventive action (CAPA) procedures. Nonconformance 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.

MasterControl CAPA integrates corrective action process with other quality processes to ensure FDA 21 CFR Part 820 compliance. 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.

(FDA 21 CFR 820 Subpart B, Sec. 820.22)

Appropriate controls over system documentation including access to documentation for system operation and revision and change control procedures that documents time-based system modification.

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 Visibility.

(FDA 21 CFR Part 820 Subpart M, Sec. 820.198)

Each manufacturer shall maintain complaint files-establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit.

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 according to FDA 21 CFR 820 regulations to an adverse events specialist while ensuring that required data is immediately collected.

(FDA 21 CFR Part 820 Subpart, Sec. 820.90)

Requires medical device manufacturers to establish and maintain procedures according to the FDA 21 CFR 820 policies to control product that does not conform to specified requirements. The disposition of the nonconforming product must be documented.

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.

How does FDA 21 CFR Part 820 work?

MasterControl document control and GxP process management solutions work together to meet CFR 820 requirements. For example, FDA 21 CFR 820 mandates that medical device documentation be maintained and that changes in policy or procedure be recorded. Associated documentation may include SOPs, quality manuals, design controls, CAPA information, change control records, employee training records, etc. The MasterControl document control solutions can manage any type of documentation and can automate routing and delivery paths as well as approval and archival FDA 21 CFR Part 820 procedures. MasterControl document control solutions also feature web-based functionality, a centralized archive for document safe keeping, document version control and reporting features.

Compliant - Sustained FDA 21 CFR 820 and Part 11 Compliance

MasterControl is compliant, helping you meet FDA 21 CFR Part 820 and other FDA regulations year after year, while keeping compliance costs down.

Connected - Integrated Quality Management Suite for FDA 21 CFR 820

MasterControl is connected, giving you the ability to monitor the entire quality system and continuously improve it.

Complete - Enterprise-wide Product Application for Compliance With FDA 21 CFR Part 820

MasterControl is complete, meeting every department's needs to ensure that quality initiatives are enforced across the enterprise.