Customer feedback is essential for any business, but it’s especially critical for regulated companies. In the life science industry, customer complaint forms in particular serve as an important channel for communicating problems with products and services that could affect patient safety. The U.S. Food and Drug Administration (FDA) requires pharmaceutical, medical device, and other companies it regulates to establish a system for reporting “adverse events,” such as unexpected side effects and other problems with medicines, medical devices, and other therapies. Most FDA-regulated companies use customer complaint forms to gather information about adverse events from patients and health providers.
21 CFR Part 211, which applies to pharmaceutical companies, requires the establishment of formal procedures and the maintenance of a system for reporting complaints regarding a drug. Most companies use customer complaint forms to comply with this provision. The regulation requires that complaints be reviewed by the quality control unit for investigation, and if necessary, to report the complaint to the FDA.
21 CFR Part 820, which applies to medical device manufacturers, requires the establishment of a system for “receiving, reviewing, and evaluating complaints by a formally designated unit.” The goal is to be able to address complaints promptly and properly and identify serious problems that need to be reported to the FDA. This requirement calls for the creation of a system for managing customer complaint forms.
Both 21 CFR 211 and 21 CFR 820 require the maintenance of “complaint files,” which call for a process for collecting customer complaint forms and reporting serious problems to the FDA.
ISO 9001, an international quality standard that applies to any type of organization, is the most widely used standard among manufacturers and other regulated companies that are not related to life sciences or fall within the jurisdiction of the FDA. ISO 9001 requires control of customer-related processes and periodic review of the quality management system (QMS), both of which call for customer feedback, especially customer complaints.
Most companies that adhere to ISO 9001 quality standards use customer complaint forms to gather feedback about product quality. The process is typically part of the QMS, a basic requirement of ISO 9001.
While some companies still use paper customer complaint forms, most organizations are switching to electronic forms to make it convenient for customers and also to increase efficiency in managing information. More importantly, an electronic system for managing customer complaint forms facilitates regulatory compliance by ensuring timely response to complaints and reporting to regulatory bodies.
MasterControl Customer Complaints is an easy-to-use software solution for standardizing and automating customer complaint forms and also streamlining management of customer complaints. Here are some of the benefits of using MasterControl Customer Complaints:
If you would like to learn more about the customer complaint form software from MasterControl, feel free to contact a MasterControl representative.
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