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Managing the quality processes in the medical devices industry is getting tough with the standards going stringent and involvement of technology. Once the medical device companies comply with the standards of ISO 13485. The next immediate step they need is to adopt FDA 21CFR Part 820. Only then, they get an opportunity to market the medical devices commercially in the U.S.

What is 21 CFR Part 820 Certification?

The 21 CFR 820, also referred as Quality System Regulations (QSR), took effect on June 1, 1997, to provide a framework of a basic minimum requirement for manufacturers to establish an Enterprise Quality Management System (QMS).

FDA 21 CFR Part 820 specifies the requirements for the quality system to meet FDA regulations, commonly referred to as cGMP (current good manufacturing practices). It shares some similarities with ISO 13485 especially when it comes to the requirements for the quality system. It includes other parts as well like

  • Part 810 – It specifically deals with the recall procedure of medical device(s)
  • Part 830 – It deals with unique device identification of medical devices.

FDA 21 CFR Part 820 enables organizations to;

  • Align their documentation structure, which is merely an external condition by U.S. govt., for standardized processes and workflows.
  • Commercially distribute their devices on a larger scale.

All the requirements defined under 21 CFR 820 are quite generic. This certification matters for attaining compliance while ISO 13485 helps to attain the state of conformance.

What are the benefits of having 21 CFR Part 820 QMS Software?

Some of the benefits of having 21 CFR Part 820 Quality Management System are:

Improved Document Control

A 21 CFR Part 820 QMS Software like Qualityze offers you a centralized location to store all your business-critical documents and manage them. Once the documentation process is managed well, you will be able to save yourself from loads of efforts to meet compliance. Each document’s revision history allows you to keep better control of the process.

Better Employee Training Programs

Implement a certified FDA 21 CFR Part 820 QMS Software in your organization to help you create better employee training programs based on the complaints and defects, Corrective Actions and Preventive Actions, and work instructions to ensure that employees are competent enough to perform the designated role and responsibilities.

Effective Audit Management

FDA has mandated the regular audits for the medical device industry in order to keep a check on the effectiveness of quality processes and system. Certified FDA 21 cfr Part 820 quality management software can help you comply with regulatory standards by enabling you to define, schedule, and conduct audits. The software will also enable you to analyze audit findings, implement required action plans, and conduct effectiveness check for the actions plans implemented.

Efficient Tracking and Reporting

Effective tracking and reporting support well to comply with FDA requirements. It’s high time to get a certified QMS tool like Qualityze that can help you to track all the processes efficiently and to prepare detailed reports on trends and factors affecting the quality of products, processes, and systems.

Improved Supplier Quality

The regulations cannot be met by ignoring the aspect of supplier quality management. Make sure you get a powerful 21 CFR Part 820 quality management software like Qualityze to control supplier quality without harming or delaying the current processes. Qualityze supplier quality management helps you manage supplier records and track their performance for better traceability.

Robust CAPA Processes

Having an effective CAPA process is also an essential part of FDA compliance. You need the intuitive QMS tools that can help you link nonconforming records to corrective action and preventive action processes to implement right action plans and can perform the risk assessment to ensure that the implemented CAPA is effective.

Better Risk Management

Risk assessments are generally done to record the why behind the important business decisions. Get a QMS tool that helps you perform a thorough risk assessment before implementing any action plan. If you will maintain such commitment, you will shine through every quality management activity you perform afore regulators and consumers.

You can just ensure conformity with ISO 13485 only, make sure you have FDA 21 CFR Part 820 to attain compliance for your medical devices. Want to know more, get in touch with our technical team today.

Current Good Manufacturing Practice (cGMP) governs the practices used in designing, manufacturing, labeling and packaging, and servicing of finished devices that are intended for human use.  Additionally, the cGMP also governs the facilities requirement for manufacturing and storing environment.

Qualityze Solution Information Matrix for 21 CFR Part 820

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

Requirements Section Description Qualityze Modules
820.20 Management Responsibility Quality policy. Management with executive responsibility shall establish its policy and objectives for, and commitment to, quality.

Management review. Management with executive responsibility shall review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and the manufacturer’s established quality policy and objectives. The dates and results of quality system reviews shall be documented.

Quality system procedures. Each manufacturer shall establish quality system procedures and instructions.

  • Change Management
  • Document Management
  • Dashboard & Reports
  • EQMS Suite & User Portal
820.22 Quality Audit Each manufacturer shall establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system.
  • Change Management
  • Document management
  • Training Management
  • Audit Management
820.25 Personnel  Each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed.
  • Document Management
  • Training Management


820.40 Document controls Each manufacturer shall establish and maintain procedures to control all documents that are required by this part. Each manufacturer shall maintain records of changes to documents.
  • Change Management
  • Document Management
820.90 Non-Conforming Product Each manufacturer shall establish and maintain procedures to control product that does not conform to specified requirements. The procedures shall address the identification, documentation, evaluation, segregation, and disposition of nonconforming product. The evaluation of nonconformance shall include a determination of the need for an investigation and notification of the persons or organizations responsible for the nonconformance. The evaluation and any investigation shall be documented.
  • Nonconformance Management
  • CAPA Management
  • Document Management
  • Training Management
820.100 Corrective and Preventive Action Each manufacturer shall establish and maintain procedures for implementing corrective and preventive action. All activities required under this section, and their results, shall be documented.
  • CAPA Management
  • Document Management
  • Training Management
820.180 General requirements All records required by this part shall be maintained at the manufacturing establishment or other location that is reasonably accessible to responsible officials of the manufacturer
  • Change Control Management System
  • Nonconformance Management
  • CAPA Management
  • Document Management
  • Training Management
  • Audit Management
  • Supplier Management
  • Complaint Management
820.198 Complaint Files Each manufacturer shall maintain complaint files. Each manufacturer shall establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit.
  • CAPA Management
  • Document Management
  • Training Management

Related Links

Quality and Compliance Management Software
ISO 9001 Quality Management Software
ISO13485 Quality Management System
FDA 21 CFR Part 11 Software
AS 9100 Quality Management Software
TS 16949 Automotive QMS Software