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監査管理システム

MasterControl's Automated Audit Management System can dramatically reduce the time and effort involved in preparing for and conducting audits. Almost all types of businesses undergo audit, but it is particularly critical for Life Science and other regulated companies. For these organizations, regular audits are necessary to comply with regulations and to ensure product safety and quality. That is why regulated companies are increasingly using audit management software systems to facilitate all audit-related tasks and activities.


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Product Information

MasterControl's automated audit management system can dramatically reduce the time and effort involved in preparing for and conducting audits.

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  • MasterControl Audit facilitates all tasks and activities from start to finish of an audit. The solution automates planning and scheduling of audits and provides checklists with audit scoring, powerful analytics and reporting capabilities, and audit workspace for managing all information.
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Audit Assessment
  • MasterControl QEM Assessment will help you overhaul and streamline ineffective quality systems and resolve CAPAs, deviations, and nonconformances. This consulting service includes data gathering through interviews and in-depth meetings with your team.

Demos & Toolkits

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

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Interactive and Live Demonstrations
  • MasterControl offers the most complete choice of integrated solutions covering all core areas necessary to successfully maintain quality and compliance processes, as well as a variety of services based on industry best practices.
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Toolkits
  • The Audit Toolkit is your one-stop shop for information you need to build an efficient and compliant audit program or to improve your existing program. It includes four videos, two white papers, and three data sheets for audit solutions and services.

Educational Materials

Get insider information about the most relevant issues in Audit Management Software Systems today, and how to navigate and overcome the complexities of FDA Audits.

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  • This white paper explains how you can turn an audit from an adversary process into an occasion for auditees and auditors to work together in improving performance. It gives an overview of the different types of audits, how to use it as a primary tool for continuous improvement, as well as for ensuring a compliant system.
  • This white paper discusses common audit-related challenges faced by non-clinical research laboratories that still use a paper-based quality system. Learn the five key benefits of switching to an automated system.
Educational Materials
E-Book
  • 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.

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Audit Management Software Systems for Companies in FDA and ISO Environments


監査管理システムや電子監査管理システムの需要は、品質規制及び品質規格への準拠という規制対象企業のニーズに端を発しています。

The FDA's regulations, such as 21 CFR 211 for pharmaceutical companies, Quality System Regulation (21 CFR 820) for medical device firms, and 21 CFR 606 for blood establishments all require regular audits. Similarly, audits are expected of general manufacturers that adhere to the ISO 9000 quality standards and medical device firms that follow ISO 13485 standards. Audit management software systems and electronic audit management systems that exist in the market today are generally designed to address those regulations and standards.


How Can MasterControl Audit Management Software Help You?


Audits must be performed regularly to be effective. MasterControl Audit™ is an electronic audit management system designed to facilitate regular audits by making them faster, easier, and more effective. MasterControl's audit management software integrates the different steps of the audit process-from preparation to completion- to ensure compliance.


以下に、監査プロセスに関連する最も一般的な問題にマスターコントロールがどのように対処するかについて概要を示します。

Audit Management System Challenges

MasterControl Audit Management Software Systems


Disconnected Audit Management Systems

効果的なコンプライアンスと監査管理システムを維持するには、複数のシステム間の連携が必要です。例えば、監査すべき対象、リスクシステムから入力を要求する頻度を把握すると、監査結果は是正措置・予防措置(CAPA)に繋がる可能性があり、承認されたベンダーのリストを維持するにはベンダーの監査からのフィードバックが必要になります。


Connected Audit Management Software

マスターコントロールは監査ソフトのプロセスを残りの品質システムと連携し、品質マネジメントに対して全体的なアプローチを採ります。監査データはサプライヤーのスコアカードと統合され、リスクスコアによって実行する監査の頻度及び種類を変えることが出来、CAPAやSCARなどの品質イベントフォームは監査の結果から直接起動することが出来るため、プロセスが合理化され、監査中に発生した問題に適切に対処出来るようになります。


Inefficient Audit Scheduling

監査の計画及びスケジューリングは見かけによらず複雑になることがあります。一部の監査は定期的な周期で発生しますが、実行する監査の種類(内部、顧客、コンプライアンス)と頻度は多数の要因によって異なることがあります。その他の監査はその場その場で行われ、全てが完了するようにリソースを管理することは、特に多数の監査がある会社の場合、大きな障害となる可能性があります。

Advance Audit Scheduling

Automates planning of all recurring audit management related activities so they won't be overlooked. Scheduling conflicts that result from double-booked auditors or out-of-office events are highlighted for easy resolution. The audit calendar can be searched and filtered to streamline the scheduling process.


Audit Management Results Lack Visibility

It's difficult to generate accurate and timely reports and trends using disparate electronic spreadsheets and paper documents. Without an effective audit reporting tool, managers are unable to see the big picture of their audit management program.

Audit Management Software Increases Visibility

カスタマイズ可能なレポートとオンラインのカルテ記入を含む、強力な分析及びレポート作成機能を提供します。レポートを通じて管理者は監査プロセスをリアルタイムで閲覧し、品質システムの向上に関してより積極的になることが出来ます。監査管理ソフトで監査中に発生した問題を容易に追跡し、問題が解決されたことを確認することが出来ます。



  1. Advanced Audit Scheduling: Create a plan of all audit-related activities with an easy-to-use, drag-and-drop audit scheduling calendar. Set up groups to view audits by status, type or auditor. Filter groups to display only the views you need. Avoid scheduling conflicts with functionality that automatically sends notifications and updates of appointments to auditors and displays any conflicts (double-booked, out-of-office, etc.). Create an automatic risk-based schedule of future audits based on audit results or the importance of the process, supplier, system, etc. being audited.
  2. Simplified Approval Processes: Eliminate the time-consuming tasks of manually distributing paper reports to all the stakeholders and locating appropriate personnel for signatures. Set up a different default approval group for each type of audit. Notifications are automatically sent when a report needs an approval. The electronic record reveals who has signed and which signatures are missing and can be included as a signature manifest on the issued audit report.
  3. Increased Visibility of Overall QMS: Track and trend observations by finding, rating and category to better understand where issues are occurring. Connect audit process to CAPA, change control, training and other quality processes. Get a real-time view of the audit process through advanced analytics and reporting, including customizable reports and online charting. Easily identify all weak areas to improve internal processes and prepare for future inspections.
  4. Checklists: Create multiple checklist templates for different audit types to ensure standardization across your organization. Import standards and criteria from industry regulations, and customize your checklist templates by selecting just the applicable sections. Auditors can complete checklists online, offline through Microsoft Word or on a mobile device.
  5. Controlled Response Collection: Assign observations to internal users or to external responders via a guest connection to enable direct response entry. Create fully customizable Microsoft Word templates to capture offline responses. Create and track actions directly from the observations.
  6. Automated Audit Report Creation: Create fully customizable audit report templates and assign them to different audit types. Allow peer review collaborations of reports and submit them for approvals. Create default approval groups for different audit types, and generate PDF documents with watermarks and signature manifests.
  7. Centralized Audit Management for Multiple Audit Types: Facilitate all the audit-related tasks, activities and reports for various audit types with different requirements and complexities. Enable multiple auditors to collaborate from a single audit workspace. Filter audits by type, status or auditors. Generate global trending reports.
  8. Fully Satisfies 21 CFR Part 11 Requirements: Limit access to authorized users. Require dual-password approval process. Enforce third-party password certification. Ensure that electronic records are reliable and authentic using a secure, time-stamped audit trail that records the identity of anyone who creates, modifies or deletes an electronic record.
  9. Closed Loop Process: Create actions ranging from a simple notification through an action item form with a review and approval cycle or up to a full issue review/CAPA process or Deviation form. The Audit Management Software closes the loop for an audit by creating a final consolidated report for management, which includes all the data from the issued audit report, responses and any action information.

What Sets MasterControl Audit Apart from Other Audit Management Software Solutions?

MasterControl provides professionals with superior tools to conduct and manage the perfect audit. With MasterControl's unrivaled audit management system, auditors can:

  • Microsoft WordやOutlookのようなよく慣れたツールを利用して快適に監査を行う
  • Effortlessly plan and schedule audit management resources using MasterControl's online drag and drop calendar
  • 監査人の入力とピア・レビューから自動化されたレポート生成まで全て維持されるリッチテキストデータのおかげで監査管理ソフトの容易なレポート作成を利用する
  • CAPAやサプライヤー、リスクのストレスのない管理を実現するシームレスな連携を楽しむ

Top 5 Benefits of MasterControl Audit Management Software

  1. Simplifies Auditor's Job: Task-based system allows auditors to easily and efficiently participate in different stages across multiple audits. They can complete their tasks faster and more effectively when companies have readily-available, organized and comprehensive documents
  2. Reduces Audit Preparation Time and Effort: Planning, scheduling and conducting audits requires much less time and resources. Creating templates for audit memos and announcement letters facilitates fast, consistent and professional communication.
  3. Instant Access to Important Data: Company executives have immediate access to critical data, which makes it easier to pinpoint the root cause of non-compliance issues. This helps them maintain confidence with audit processes and achieve their continuous improvement and compliance objectives.
  4. Consolidation of Data: With quality audits, data is commonly interspersed and controlled using a variety of processes and procedures. An automated audit management system enables auditors to consolidate data from disparate tools and other auditors and manage it all from a centralized tool.
  5. Easy to Implement and Validate: The unique validation approach significantly reduces the time, effort and costs involved with validation.

Top 10 Features of MasterControl Audit Management Software

  1. Connected Audit Management: Integrate all the steps of the audit process from preparation to completion. Automatically determine what should be audited and how often by integrating with Risk, Supplier, and our new Studies module. Launch quality event forms, such as CAPAs and SCARs, right from the audit findings. Web-based platform allows all employees involved in audits to connect from virtually anywhere. Guest connections provide external responders secure and direct access to the audit.

監査管理システムの詳細


For more information about audit management software systems or the solutions from MasterControl, please don't hesitate to contact a MasterControl representative.

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