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品質報告システム

MasterControl's Customer Complaints Management Software Systems are designed by industry practitioner for automating the Customer Complaints Management process in any organization. A Customer Complaints Management Software system is the crux of any quality and compliance process. It is a regulatory requirement that FDA / global regulatory inspectors and ISO auditors consider critical. An automated Customer Complaints Management system reduces audit time and findings, and a decreases risk of product recalls. It improves product quality and safety, increases customer satisfaction, and ensures FDA and ISO compliance.


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Product Information

Discover how MasterControl Customer Complaints Management Software can manage your Customer Complaints Management process, all while mitigating risk, improving speed-to-market, and generating ROI.

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  • Discover how MasterControl Customer Complaints™ addresses the three key complaints-handling challenges of different sources, disconnected processes and an inefficient complaint process by automating complaint handling and integrating it with your quality system.

Toolkits & Demos

Get in-depth, comprehensive resources to guide development of your Customer Complaints Management program

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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 Customer Complaints Management today, and how to navigate and overcome the complexities of FDA and ISO regulations.

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  • Effective complaint handling is not just a good business practice, but a critical compliance requirement in FDA and ISO environments. Learn the strategies and solutions for managing complaints and turn complaints-related challenges into opportunities for improvement.
  • QMS and CAPA expert Ken Peterson explains how to implement a CAPA system based on deductive reasoning and comparative analysis that follows the “Investigation Funnel” methodology. Learn how to establish a common CAPA model and language within your organization.


Customer Complaint Management Software and Its Role in Regulatory Compliance


効率的な品質報告システムの構築は、どの企業にとっても適切なビジネス手法を確立する上で重要です。 迅速かつ効率的な苦情管理は、不適合製品の出荷の削減や労働コストの削減、工場ダウンタイムの削減に繋がります。しかし、品質が最優先のFDA及びISO環境では更に大きな意味を持ちます。苦情は、FDA及びその他のグローバルな規制機関に、生命を脅かす可能性のある製品の不適合性について警告します。これらの不適合性は、自動化された 品質報告システム ソリューションを導入することで容易に管理出来ます。

医療機器や医薬品、生物製剤などの規制対象業界は、死亡や重傷、副作用に関して品質報告システムを通じて寄せられた苦情を全て報告する必要があります。一部の FDA規制 (21 CFR Part 820.198や 21 CFR Part 606 .170など)では、正式な苦情管理プロセスも必要とされます。品質報告システムにより、このプロセスは簡素化されます。

苦情はISO認定企業にとっても重要です。ISOコンプライアンスは主に自発的に実行されますが、一部の国ではいくつかの規格が薬事規制フレームワークの一部として採用されていたり、市場要件になっている場合もあります。一連の ISO 9000 品質マネジメント規格が、顧客または市場の要件になっているISO規格の良い例です。堅牢な品質報告システムソリューションを含む有効な品質報告システムを構築すると、規制対象製造業者はISOコンプライアンスを維持することが出来ます。


How Customer Complaints Management Software Meets the Challenges of Complaint Resolution


While the importance of a well designed customer complaint management system in attaining regulatory compliance is irrefutable, implementing one isn't easy. When you consider the challenges associated with complaint handling, it's hard to imagine how a company could hope to resolve complaints quickly and efficiently without a customer complaint management software solution. Some of the challenges include:

  • Disparate Complaint Gathering: Customer complaints come from a wide variety of sources: phone, email, sales reps, internal employees, and social media. If your customer complaint management system is paper-based and lacks a standard procedure for capturing or processing complaints, it's highly likely that complaints will fall through the cracks, essentially not making it from someone's email or voicemail into the resolution process. In today's social media age, allowing customer complaints to languish on Twitter or Facebook in front of millions of consumers can cause serious, perhaps even irreversible, reputation and brand damage. Automating your homegrown or manual customer complaints management system with an electronic customer complaints management software system can not only better protect your customers, but also protect your company's reputation and bottom line.
  • Detached Processes: Customer complaint management is a complex process, requiring an enterprise-wide commitment and a unified approach. Unfortunately, many regulated companies, particularly those that rely on a paper-based system rather than an electronic customer complaint management software system, utilize a variety of tools to track and follow up on quality events and complaints. Because of the many sources that feed into the customer complaint management system, this disparate approach compromises collaboration, which can lead to increased error or worse, lost complaints. Automating your complaint management and resolution procedures with an integrated customer complaint management software tool such as MasterControl Customer Complaints™ can help you standardize these processes and correct problems expeditiously.
  • Lack of Efficiency: Both of the above mentioned challenges lead to what is perhaps the biggest challenge to any customer complaints management system: inefficiency. Multiple gathering sources coupled with disconnected processes make it almost impossible for any regulated organization to resolve complaints sufficiently using a paper-based or partially electronic complaint-handling system. Manual systems are plagued by bottlenecks: lost or overlooked complaints, incomplete information, inadequate response time or no response at all. MasterControl's customer complaints management software can help your organization achieve efficiency through automation.


Features and Benefits of MasterControl's Customer Complaint Management Software


MasterControl Customer Complaints™, an integrated part of the MasterControl quality management suite, allows you to create a unified, closed-loop customer complaint management system for tracking complaints across processes, departments, and geographical locations. By automating all complaint-related tasks, such as data collection, notification, follow-up, and escalation, MasterControl's customer complaint management software makes it easier to comply with rigorous regulations from the FDA, EMA, and other regulatory agencies, as well as stringent ISO standards. Here are just a few of the many advantages gained by implementing MasterControl Customer Complaints:

  • Improved Documentation: Using a pre-configured, multi-page electronic form that ensures accurate complaint data capture, the solution streamlines the documentation portion of your customer complaints management system into a simple three-step process: complaint processing, complaint investigation, and finally, complaint resolution. Every step of the process is automated and documented.
  • Advanced Reporting Capabilities: MasterControl's customer complaints management software solution offers advanced analytics and reporting tools to allow for increased management oversight; this increased transparency improves decision making throughout the customer complaint management system. MasterControl Customer Complaints includes the following customizable reports: complaint summary; complaints categorized by type, product, and department; in-process complaints; and trending categorized by complaint type, product, and department. The solution also includes the FDA's MedWatch 3500A form for mandatory reporting of adverse events.
  • Corrective Action and Preventive Action (CAPA) Integration: The overall effort to investigate and streamline quality events is the foundation of any customer complaints management system. MasterControl CAPA™ is an easy-to-use software solution designed to automate and effectively manage all activities associated with the CAPA process, such as triggering events, performing root cause analysis, and assigning the necessary follow up action-all while integrating CAPA with other quality processes, such as change control and audit. Seamless integration is what sets MasterControl's customer complaint management software apart from other solutions.
  • Continuous Compliance: Continuous compliance is, or should be, the quality goal of all regulated manufacturers regardless of industry. To achieve this, every complaint that comes through the customer complaint management system must be properly evaluated, thoroughly investigated, and sufficiently corrected. MasterControl will not only help you attain compliance with the FDA, ISO, and other regulatory agencies, but also help you sustain that level of compliance over the long haul.
  • Industry Customization: MasterControl offers a customer complaints management software solution customized for the medical device industry, MasterControl Customer Complaints MD™, as well as a solution designed for the pharmaceutical industry, MasterControl Customer Complaints Pharma™.

品質報告システムの詳細情報


To learn more about creating, implementing, and maintaining a unified customer complaints management systems, please feel free to contact a MasterControl representative.

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