FDA 21 CFR Part 820

FDA 21 CFR Part 820 Quality System Regulation QSR Requirements for Medical Device Manufacturers for FDA 21 CFR Part 820 Compliance

(FDA 21 CFR Part 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.

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 Part 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 Part 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 Part 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.

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