品質報告手続き


Why is MasterControl Customer Complaint Procedures Software Right for You?

MasterControl Customer Complaints™, an integrated part of the MasterControl quality suite, automates and manages customer complaint procedures in an efficient and cost-effective manner. Here are some of its robust features to ensure your system is always Compliant, Connected, and Complete:

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Compliant Customer Complaint Procedures Software

Sustained Compliance: MasterControl's customer complaint procedures software helps biotechnology companies attain and sustain FDA GMP compliance by optimizing the process of customer complaint management by speeding up the turnaround from complaint submission to resolution, and keeping the overall quality system always ready for FDA GMP inspections or ISO quality audits.

  • Increase the Efficiency of Customer Complaint Procedures Through Automation: MasterControl software automates all tasks pertaining to customer complaints, including notification, follow-up, and escalation of overdue assignments. Automation helps simplify the compliance environment, making it easier to stay compliant.
  • シンプルな3ステッププロセス: このベストプラクティスプロセスは、事前設定済みの複数ページからなるフォームに組み込まれています。このプロセスは、苦情の処理から始まり、内部調査に自動的に移行し、問題解決で終了します。
  • 集中化されたリポジトリ: 苦情管理に関連する全ての品質報告手続きは1つの安全な集中化されたリポジトリに保管され、FDA査察や ISO監査時 にそれらの文書の検索と抽出が容易になります。
  • Analytics and Reporting for Customer Complaint Procedures: MasterControl's advanced analytics and reporting capability increases management oversight and demonstrates appropriate controls to regulatory agencies. The solution includes the following customizable reports: complaint summary; in-process complaints; complaints categorized by type, product, and department; trending categorized by complaint type, product, and department.
  • MedWatchフォーム : 品質報告手続きによって有害事象のレポート作成を合理化することが出来ます。このレポート作成には一連の固有の薬事規制要件が使用されます。このソリューションには、有害事象についての必須の報告のための、FDAのMedWatch 3500Aフォームが含まれており、有害事象の専門家にシームレスに引き渡すことが出来るとともに、必要なデータをすぐに収集出来ます。
  • Solid Audit Trail: Customer Complaint Procedures Software Provides a secure, time-stamped audit trail as required by 21 CFR Part 11. MasterControl documents the identity of anyone who creates or modifies an electronic record, when the action occurred, and the changes made.
  • 改訂管理: マスターコントロールは、文書の現在のバージョンのみ利用可能にします。

Connected Customer Complaint Procedures

連携された品質管理: マスターコントロールでは、ペーパーレスの 品質報告ソフトウェア とその他の品質プロセスを連携して、品質管理の全体的アプローチを実現します。

  • Easy Access: MasterControl Customer Complaint procedures software is configured on a web-based system so it can connect employees, customers, suppliers, and others involved in the customer-complaint process regardless of location.
  • External Links: MasterControl connects the complaint-handling process to the rest of the quality system, providing links to corrective actions and adverse-event handling. Via an external link, this solution can be integrated with other computer systems. For example, a link can be provided on a company website, within a CRM application (or any application that supports URL links), so employees, customers, or partners can easily initiate a customer complaint. This connectivity will help managers track a complaint from initiation to completion and give them the ability to proactively improve the customer complaint procedures.
  • CAPA Integration: MasterControl provides the option to integrate customer-complaint handling with the corrective and preventive action process to automatically escalate any serious quality problem.

Complete Customer Complaint Procedures Software

Enterprise-wide Product Application: MasterControl can handle every department's forms and documents-based processes with the help of customer complaint procedures software, making it an ideal enterprise-wide solution.

  • Integrate Customer Complaint Procedures Software with Other Applications: MasterControl can integrate with other applications like ERP, LIMS, accounting, and human resources applications to accommodate departmental needs.
  • 容易な検索: 標準化されたGoogleに似た検索ウィンドウをアプリケーション全体で使用して、組織内の承認された全てのユーザーは 変更管理 関連のタスクと文書を検索及び抽出することが出来ます。
  • Easy to Find: MasterControl's Explorer, similar to Windows Explorer, is an easy-to-use tool that helps users find and access documents quickly. Every department can maintain its own Explorers and documents can be stored in multiple Explorers. System administrators can control and automatically update the documents through a dynamic link in the InfoCard.
  • Automation of Forms-Based Processes: Any forms-based process unique to a department (i.e., application forms for HR, customer satisfaction survey forms for Customer Service Department) can be automated. A department can keep the look and function of existing forms or create entirely new customer complaint procedures.

For More Information on Customer Complaint Procedures Software

For more information about customer complaint procedures, please feel free to contact a MasterControl representative.