Dealing with customer complaints is inevitable in any kind of business. They are especially critical for medical device companies because complaints may indicate serious safety issues.
The Quality System Regulation ( 21 CFR Part 820 ) requires medical device companies to establish and maintain procedures for receiving, reviewing, and dealing with customer complaints by a formally designated unit, as well as to maintain complaint files. There are similar requirements for ISO-certified medical device companies. ISO 9000 requires management to review feedback from customers, especially complaints. ISO 13485 requires the establishment of a procedure to gather feedback from customers as a way of monitoring quality.
Wählen Sie alle Ressourcen aus, die Sie herunterladen möchten
The MasterControl™ integrated quality management suite is a configurable and easy-to-use software solution that helps ensure regulatory compliance. Recognizing the significance of dealing with customer complaints with software, and that validating a software solution ( as required by 21 CFR Part 11 ) is a necessary component in CGMP 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.
MasterControl Customer Complaints™ software is a complete and easy-to-use solution for dealing with customer complaints that helps FDA-regulated contract organizations to automate complaint handling, integrate it with the quality system, and manage complaint resolution more effectively. Here's how it can answer key challenges in the customer complaint process:
FDA Contractors Customer Complaints Handling Challenges
MasterControl Customer Complaints Software Solution
In a manual system, dealining with customer complaints may prove to be more complex than it is profitable. Complaints for example 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 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 complaint resolution.
MasterControl Customer Complaints software 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 system for dealing with customer complaints makes search and retrieval of complaints and related data easy. The solution offers the capability to formalize and standardize complaint handling through a simple three-step process. MasterControl is web-based, so customers can log complaints from virtually anywhere.
When a company uses different tools that are not connected, tracking complaints and follow-up work can be a major obstacle. If there is no standardized response to complaints, the required documentation may fall through the cracks and correction of the problem, delayed.
Connected Software System
MasterControl connects the customer complaint process to the rest of the quality system, providing links to corrective actions and adverse event handling for better dealing with customer complaints. 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 complaint from initiation to completion and give them the ability to proactively improve the complaint-handling process.
Unwarranted Legal Exposure
In a manual system for dealing with customer complaints, record keeping may be inadequate for the purpose of answering a product liability lawsuit. Managers don't have the ability to track 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
MasterControl 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.
Dealing with Customer Complaints: Inefficient Complaint Processes
A manual 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.
Dealing with Customer Complaints with an Efficient Complaint Process
MasterControl's complaint software will reduce the life cycle of the complaint process by streamlining different steps and consolidating different sources of complaints under a single platform. It provides a customizable form that captures all necessary information required for dealing with customer complaints, provides automatic follow-up via e-mail notification, and incorporates escalation to ensure timely response.
MasterControl Customer Complaints is a robust software solution that manages dealing with customer complaints more efficiently and effectively with the help of the following features:
Simple Three-Step Process - This best-practice process for dealing with customer complaints, 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 a resolution of the issue as approved by the appropriate manager. Additional forms can be customized according to a company's special needs.
Compliant System - 21 CFR Part 11 requires an audit trail as a key control in making electronic records reliable. 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 meets FDA requirements for electronic signature and software validation which makes dealing with customer complaints very effective. It facilitates compliance with regulatory standards such as ISO 9000, ISO 14000, and ISO 13485.
Analytics and Reporting Tool - MasterControl's advanced reporting capabilities increase management oversight and demonstrate appropriate controls to regulatory agencies. The solution includes the following customizable reports:
MedWatch Form - For an FDA-regulated company, a customer complaint may turn out to be the reporting of an adverse event, which comes with its own set of regulatory requirements. MasterControl Customer Complaints includes the FDA's MedWatch 3500A form for mandatory reporting of adverse events, allowing a seamless handover to an adverse events specialist for dealing with customer complaints, while ensuring that all required data is immediately collected.
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. Theses combined features make dealing with customer complaints and with CAPA far easier.
Sustained Compliance - Regulated companies cannot ignore customer complaints. They are the ultimate indicators of product/service quality. Every complaint has to be properly evaluated, investigated, and the situation, corrected. MasterControl Customer Complaints is designed to streamline and simplify the process for dealing with customer complaints, foster efficiency throughout the enterprise, and keep compliance costs down. MasterControl will not only help you attain FDA and ISO compliance but sustain it year after year. With MasterControl, you can count on a partner that will support your compliance efforts over the long haul.
If you would like more information about the MasterControl software for dealing with customer complaints, feel free to contact a MasterControl representative.