Customer Complaint Management System
As they say, the customer is always right. In regulated environments, the motto takes on a new significance. The stakes are higher when complaints come from adverse events or safety issues. For this reason, many regulated companies are switching from legacy systems to fully automated complaint management systems.
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Role of Complaint Management Software in Regulatory Compliance
The FDA’s Current Good Manufacturing Practice (CGMP) regulations and ISO quality standards require a formal complaint management system. Customer complaints alert regulators about potential quality issues, making complaint management crucial. For regulated companies, complaints offer a chance to address issues quickly. The need for a timely response to quality problems compels many companies to use complaint management software. Thousands of companies worldwide use MasterControl to comply with regulations and ensure product quality and safety.
Why You Need MasterControl Customer Complaint Management Software
In a fast-paced regulated environment, you need to be able to collect customer complaints, categorize the incidents, and process them for a timely and effective disposition. You also need to be able to track the complaints, escalate them if necessary, and identify any correlation or related quality events to get the big picture. MasterControl’s robust complaint management system is designed to address all of those needs every step of the way, from the complaint input through disposition and resolution.
Complaint Management System Features
A robust solution for optimizing complaint management
- Ease of UseMasterControl Customer Complaints is an easy-to-use software solution for automating paper-based complaint management systems. A cloud infrastructure means your system will be up and running immediately.
- Best-Practice FormsMasterControl helps ensure compliance by providing best-practice forms and a complaint management process designed to address FDA, ISO and other regulatory requirements.
- Centralized LocationMasterControl provides a centralized location for all records related to complaint management and other quality processes. End users will be able to retrieve information from a single location. During audits, all relevant information will also come from one place, making the process faster.
- Connected PlatformAn integrated platform like MasterControl connects complaint management to document control, CAPA, training control and other quality processes for a seamless compliance effort.
- Powerful AnalyticsA powerful analytics and reporting capability allows stakeholders to leverage quality data in making decisions, understanding trends and predicting outcomes.
- Best-Practice ProcessesWith MasterControl, risk management is built into best-practice processes to help companies evaluate and mitigate risks that impact product quality.
Challenges |
MasterControl Solutions |
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Inefficient It takes longer to gather customer complaints using paper forms. Manual data entry is also prone to errors. All of this can cause delays in disposition of complaints. |
Efficient MasterControl’s customer complaint management software greatly increases efficiency by automating the entire process, beginning with the collection of complaints from various channels through the resolution of incidents. |
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Lack of Standardization Complaints may come from paper forms, phone calls, email messages and social media. The lack of a standard procedure for capturing and resolving complaints makes it more difficult to comply with required documentation. |
Standardization MasterControl standardizes complaint management with best-practice forms and workflow that will guide users throughout the process. Standardization makes it easier for everyone in the organization to comply with requirements. |
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Lack of Connectivity In a manual system, customer complaint management is not integrated with the corrective action and preventive action (CAPA), nonconformance, audit and other quality processes. The lack of connectivity can cause delays in addressing complaints and requires extra vigilance on the part of stakeholders. |
Connected Processes MasterControl provides an integrated platform that connects the complaint management system with CAPA for a seamless escalation if necessary. The connectivity makes it easier to see if the complaints have correlation to nonconformances or other quality events. |
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Lack of Transparency Tracking down customer complaints in paper forms and those coming from social media or a corporate website is harder when the information is not transparent. Likewise, paper documents are not readily visible or accessible during an audit. |
Increased Transparency MasterControl makes the complaint management process transparent to users and auditors alike. The system’s dashboard, audit trail and reporting capability make quality data accessible and easier to use. |
QMS-Anbieter für die FDA
MasterControl Inc. und sein Partnerunternehmen i4DM erweitern ihr FDA-Projekt und wollen als QMS-Anbieter für einen zweiten FDA-Bereich fungieren. Die beiden Unternehmen sind seit 2009 als QMS-Anbieter für das Office of Regulatory Affairs der FDA tätig und möchten nun auch als Qualitätsanbieter für die Division of Pharmaceutical Analysis fungieren, die Teil des Center for Drug Evaluation and Research der FDA ist.
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