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The MasterControl Customer Complaints software is an integrated customer complaint management system that is a configurable and easy-to-use solution that helps ensure regulatory compliance. Recognizing that validating an electronic customer complaint management system is a necessary component in regulatory compliance, MasterControl offers full-cycle validation services, including IQ, OQ, and PQ validation tests. MasterControl continuously develops new methods to cut the time involved in validating a system and to make it easier to validate software upgrades, both of which are essential in lowering overall validation cost.
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Customer complaint management software systems, such as the one from MasterControl (MasterControl Customer Complaints), is a complete and easy-to-use software solution that helps FDA-regulated contract organizations automate customer complaint handling, integrate it with the rest of a company's quality system, and manage customer complaint resolution more effectively. Here's how the customer complaint software from MasterControl can answer key challenges in the customer complaint process:
|Customer Complaints Handling Challenges||The MasterControl Customer Complaint System|
|Different Sources of Customer Complaints
In a manual customer complaint system, customer complaints may come from different sources (e-mail, phone, fax, letters, corporate Web site, sales reps, etc.). These complaints may languish in someone's 'in' box, especially if there is no formal complaint system and standard procedure for processing them. Without a cohesive structure that captures complete information in a timely manner, it is almost impossible to formulate a strategy for customer complaint resolution.
|Centralized Source for Customer Complaints
MasterControl's customer complaint software system provides a secure and centralized platform for receiving customer complaints and storing all subsequent documentation pertaining to investigation and correction of the problem. A single, cohesive customer complaint system makes search and retrieval of complaints and related data easy. The complaint system offers the capability to formalize and standardize customer complaint handling through a simple three-step process. MasterControl's customer complaint system is Web-based, so customers can log complaints from virtually anywhere.
|Disconnected Complaint Handling Processes
When a company uses different customer complaint system tools that are not connected, tracking complaints and follow-up work can be a major obstacle. If there is no standardized response to customer complaints, the required documentation may fall through the cracks and correction of the problem, delayed.
|Connected Customer Complaint Software
MasterControl's customer complaint software system connects the customer complaint process to the rest of the quality system, providing links to corrective actions and adverse-event handling. Via an external link, customers can integrate MasterControl Customer Complaints with other computer systems. For example, a link can be provided on a company Web site, within a CRM application (or any application that supports URL links), so employees, customers, or partners can easily initiate a customer complaint. Connectivity will help managers track a customer complaint from initiation to completion and give them the ability to proactively improve the complaint-handling process.
| Unwarranted Legal Exposure
In a manual system, record keeping may be inadequate for the purpose of answering a product liability lawsuit. Managers don't have the ability to track customer complaints and see the compliance program as a whole, both of which are essential in developing a strategy for preventing unwarranted legal exposure.
|Controlled Legal Exposure with Customer Complaint Software
MasterControl's customer complaint management software system provides advanced reporting capabilities for real-time view of the state of a company's compliance. It allows continuous monitoring and promotes improvement, both of which can help increase a company's readiness to answer any possible lawsuit. A controlled record-keeping environment that shows how complaints are investigated and addressed may help reduce legal exposure.
|Inefficient Customer Complaint Process
A manual customer complaint management system is plagued by bottlenecks: misplaced or overlooked complaints coming from disparate sources, incomplete information, lack of follow up, and inadequate response. All of these can result in delayed complaint resolution.
|Efficient Customer Complaint Process
The MasterControl customer complaint management system will reduce the life cycle of the complaint process by streamlining different steps and consolidating different sources of customer complaints under a single platform. It provides a customizable form that captures all necessary information, provides automatic follow-up via e-mail notification, and incorporates escalation to ensure timely response.
The customer complaints management system from MasterControl is a robust software solution that manages customer complaint handling more efficiently and effectively with the help of the following features:
Simple Three-Step Process - This best-practice process is incorporated in a pre-configured, multi-page form that starts with the processing of a customer complaint by the coordinator/manager, automatically moving to the internal investigation step (conducted either by an expert or a team of experts), and culminating with the resolution of the issue as approved by the appropriate manager. Additional forms can be customized in the customer complaint management software according to a company's special needs.
Compliant System - 21 CFR Part 11 requires that there be an audit trail of electronic records to demonstrate their reliability. MasterControl maintains a secure, time-stamped audit trail that documents the identity of anyone who creates, modifies, or deletes an electronic record (such as a customer complaint file), when the action occurred, and the changes made to the record. MasterControl's customer complaint software meets FDA requirements for electronic signature and software validation. It facilitates compliance with regulatory standards such as ISO 9000, ISO 14000, and ISO 13485.
Analytics and Reporting Tool - MasterControl's customer complaints system has advanced reporting capabilities increase management oversight and demonstrate appropriate controls to regulatory agencies. The solution includes the following customizable reports:
CAPA Integration - MasterControl gives you the option to integrate customer complaint handling with the corrective and preventive action (CAPA) process to automatically escalate any serious quality problem.
Sustained Compliance - Regulated companies cannot ignore customer complaints. They are the ultimate indicators of product/service quality. Every complaint has to be properly evaluated and investigated, and the situation has to be corrected. The customer complaints system from MasterControl is designed to streamline and simplify the complaint process, foster efficiency throughout the enterprise, and keep compliance costs down. MasterControl not only helps you attain FDA and ISO compliance, it helps you sustain it year after year.
Written procedures describing the handling of all written and oral complaints about a drug product shall be established and followed. Such procedures shall include provisions for review to determine whether the customer complaint represents a serious and unexpected adverse drug experience, which is required to be reported to the FDA.
Each manufacturer shall maintain customer complaint files, establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit.
Perform management reviews: Requirements include examination of customer feedback by management.
The customer complaint software from MasterControl (MasterControl Customer Complaints) complies with GxP regulations and 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 to an adverse events specialist while ensuring that required data is immediately collected.
For more information about complaint handling or the customer complaint management system from MasterControl, please feel free to contact a MasterControl representative.