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21 CFR Part 820

Maintain medical device quality and safety as per FDA's 21 CFR 820 regulation. Qualityze offers a comprehensive approach to seamlessly meet these requirements.

21-cfr-part-820

Overview

21 CFR Part 820 is a section of the United States Code of Federal Regulations (CFR) that outlines the Quality System Regulation (QSR) for medical device manufacturers. It is also known as the Current Good Manufacturing Practice (CGMP) regulation for medical devices.

Benefits of 21 CFR Part 820 Compliant Quality Management Software

There are many benefits to using 21 CFR Part 820 compliant quality management software (QMS software). Here are some of the most important benefits:

Increased compliance

Qualityze can help manufacturers to ensure that they are following all applicable regulations, including 21 CFR Part 820. The software can automate many of the tasks required by the regulation, such as document control, change management, and corrective and preventive action (CAPA). This can help to reduce the risk of errors and omissions, and it can also free up staff time to focus on other important tasks.

Improved efficiency

Qualityze can help to improve the efficiency of the quality system by streamlining processes and automating tasks. This can lead to faster product development, reduced costs, and improved customer satisfaction.

Enhanced traceability

Qualityze can help to improve traceability by tracking the movement of products and materials throughout the manufacturing process. This can help to identify and investigate problems more quickly, and it can also help to comply with regulations that require traceability.

Improved decision-making

Qualityze can provide manufacturers with insights into their quality system that can help them to make better decisions. For example, the software can track trends and identify areas where improvement is needed. This can help manufacturers to improve the quality of their products and processes.

Reduced risk

Qualityze can help to reduce the risk of product recalls and other problems by providing a system for managing risk. The software can help manufacturers to identify and assess risks, and it can also help them to implement controls to mitigate those risks.

Qualityze EQMS software is designed to help an organization to comply with 21 CFR Part 820 standards. The following matrix will provide essential information for you to understand how Qualityze Solution can help:

Which Qualityze System supports the elements of 21 CFR Part 820?

Requirements SectionQualityze Modules
Management Responsibility: Qualityze helps manufacturers to ensure that management is actively involved in the quality system. The software provides tools for managing risk, setting goals, and measuring performance.
  • Document Management
  • Change Management
  • Risk Management
Quality Audit: Qualityze helps manufacturers to conduct effective quality audits. The software provides tools for planning, scheduling, and conducting audits, as well as for tracking the results of audits.
  • Audit Management
  • CAPA Management
Personnel: Qualityze helps manufacturers to ensure that personnel are competent and qualified to perform their tasks. The software provides tools for training, assessing, and evaluating personnel.
  • Document Management
  • Training Management
Nonconforming Product: Qualityze helps manufacturers to control nonconforming product. The software provides tools for identifying, classifying, and dispositioning nonconforming product.
  • Nonconformance Management
  • CAPA Management
Corrective and Preventive Action (CAPA): Qualityze helps manufacturers to take corrective and preventive action to address identified problems. The software provides tools for planning, implementing, and evaluating CAPA activities.
  • CAPA Management
General requirements: Qualityze helps manufacturers to comply with the general requirements of 21 CFR Part 820. The software provides tools for ensuring that the quality system is documented, maintained, and reviewed.
  • Document Management
  • Change Management
  • Nonconformance Management
  • CAPA Management
  • Training Management
  • Audit Management
  • Supplier Management
  • Complaint Management
Complaint Files: Qualityze helps manufacturers to manage complaint files. The software provides tools for tracking complaints, investigating complaints, and taking corrective action.
  • Complaint Management
  • Adverse Events Management
  • CAPA Management

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