Using Customer Complaint Forms for FDA Compliance
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.
Using Customer Complaint Forms for ISO Compliance
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.
MasterControl Ensures Compliant System for Managing Customer Complaint Forms
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:
MasterControl provides best-practice customer complaint forms and process designed to address FDA, ISO, and other regulatory and quality requirements. It provides analytics and reporting tools that will show regulators that the process has appropriate controls.
Provides Centralized Location:
MasterControl automates any paper-based or hybrid customer complaint process, as well as provides a centralized location for all records, documents, and customer complaint forms. Employees will be able to search, track, and retrieve necessary information from a single location. During audits and inspections, all relevant information will also come from one place, greatly facilitating the audit process.
Connects Critical Processes:
With MasterControl, customer complaint forms and the process for managing them can be connected to other quality processes, such as document control, CAPA, change control, and training management processes. Connectivity means customer complaints will be addressed promptly. If a complaint requires a CAPA and if a CAPA requires employee re-training, MasterControl will ensure a seamless connectivity in all of these activities.
For More Information on Customer Complaint Form Software
If you would like to learn more about the customer complaint form software from MasterControl, feel free to contact a MasterControl representative.