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FDA 21 CFR Part 820 Software

Learn from industry practitioners and experts about Quality System Regulation (QSR) Requirements for Medical Device Manufacturers for FDA 21 CFR 820 Compliance. FDA 21 CFR Part 820, also known as the 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.

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Product Information

Discover how MasterControl Software can manage your FDA 21 CFR Part 820 process, all while mitigating risk, improving speed-to-market, and generating ROI.

  • What do you need to know about compliance with 21 CFR 820 and ISO 13485? This informative question and answer summary explains what these standards are, who they cover, their relationship to each other, and much more.

Demos & Toolkits

Get in-depth, comprehensive resources to guide development of your ISO 13485 program.

Interactive and Live Demonstrations
  • The MasterControl quality management system (QMS) delivers a wide range of software solutions for quality management, document control, product lifecycle management, supplier management, audit management, training management, and more based on your business needs. This overview demonstration shows how MasterControl's QMS eliminates waste, simplifies audits, and facilitates compliance with regulatory guidelines.

Educational Materials

Get insider information about the most relevant issues in 21 CFR Part 820 today, and how to navigate and overcome the complexities of ISO compliance.

  • This white paper provides a concise overview of ISO 13485 and examines how obtaining certification to the standard can open doors to untapped domestic and international business opportunities. It also explains how to avoid becoming one of the 50 percent of device companies that fail to obtain recertification due to inadequate manual processes.
  • Since the majority of medical device manufacturers must comply with both 21 CFR 820 QSR and ISO 13485 standards, it is practical to consider establishing an integrated 21 CFR 820 and ISO 13485 quality management system (QMS). This white paper delineates the intersection points of these regulatory requirements and provides valuable information about document naming and numbering strategies for enhanced compliance.
  • Since 2000, we have benefited from a technology-driven era in regulatory compliance. This e-book identifies 16 laws and initiatives that have helped spur such modernization. It explores how the use of technology in the past decade has helped both sides of the fence—regulated companies and regulatory agencies—in easing the pains and costs of compliance.

Educational Materials

Analyst Report
  • This research shows is that companies are rightly focused on risk management and analysis, but that their processes and practices may be incomplete. Learn how to avoid pitfalls and help your company make significant gains in quality, operations, and financial metrics.

MasterControl Software Designed For Compliance With FDA 21 CFR 820

MasterControl品質管理Suiteは、統合され、構成可能で、使いやすいソフトウェアソリューションであり、FDA 21 CFR Part 820及びその他の FDA規制 へのコンプライアンスを促進するために特に設計されています。医療機器製造業者が主要なQSR要件を満たし、同時に効率を高め、コンプライアンスコストを低く抑えるうえで、マスターコントロールは次の支援を行うことが出来ます。

FDA Compliance Needs

MasterControl Quality Management Software Solutions

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


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)


MasterControl Trainingは、トレーニングタスクの割り当てとモニタリング、及びオンライン試験のグレーディングを自動化します。トレーニングコースの順序を設定出来るため、前提条件が完了したら、次のコースが自動的に開始されます。グループサインオフ機能を搭載しているため、規模の大きな担当者グループのトレーニングの検証にも対応可能です。

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

FDA 21 CFR Part 820に従った製造及びプロセス変更: 各製造業者は、仕様や方法、プロセス、手順に対する変更のための手続きを確立し維持するものとします。そのような変更は実装前に確認するか適宜検証するものとし、これらの活動を文書化するものとします。

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は、是正措置プロセスを他の品質プロセスと連携し、FDA 21 CFR Part 820へのコンプライアンスを保証します。CAPAフォームは別のフォーム(つまり不適合レポート)から直接開始することが出来ます。CAPAフォームには自動的に関連データが入力されるため、データ入力が削減され、手作業による情報移行に伴うエラーが排除されます。 企業の外部の顧客とベンダーは、インターネットを通じて、CAPAにつながる可能性がある品質報告やその他のフォームを送信出来ます。管理者が品質管理ライフサイクル全体をモニタリングするのに役立つ、カスタマイズ可能なレポート作成機能が提供されます。

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

システムの操作と、時間ベースのシステム変更を文書化する改訂及び 変更管理手順 へのアクセスを含む、システムの文書化に対する適切な管理。

MasterControl Auditは、監査プロセスの自動化及び合理化ならびに効果的な管理を実現します。スケジューリングや計画から実行や完了までの高度なトラッキング機能があります。基本的な監査情報及び監査所見をトラッキングするベストプラクティスフォームを提供します。繰り返し行われる全ての監査関連活動のスケジューリングを自動化し、分析とレポート作成機能を提供して管理の視認性を向上させます。

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


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 I, 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は、適合していない原料や成分、部品、最終製品の識別や評価、レビュー、対処のためのプロセスの自動化や管理、効率化を行うように設計されています。ソリューションのベストプラクティスフォーム及び5段階プロセスにより、責任担当者全員を連携させ、不適合品の効果的かつタイムリーな処理を実現します。

FDA 21 CFR Part 820の仕組み

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

マスターコントロールはコンプライアンスを遵守し、FDA 21 CFR Part 820及びその他のFDA規制を継続的に満たすとともに、コンプライアンスコストを低く抑えるのに役立ちます。

Connected - Integrated Quality Management Suite for FDA 21 CFR 820


包括的 - FDA 21 CFR Part 820へのコンプライアンスのための、企業全体の製品アプリケーション