A Customer Complaint system is the crux of any quality and compliance process. It is a regulatory requirement that FDA / global regulatory inspectors and ISO auditors consider critical. An automated Customer Complaint system reduces audit time and findings, and a decreases risk of product recalls. It improves product quality and safety, increases customer satisfaction, and ensures FDA and ISO compliance.
Cutting-edge customer complaint handling software should be based on industry best- practice processes and incorporate pre-configured, multi-page customer complaint forms. The complaint management process should begin with the initiation of a customer complaint by a coordinator or manager. The system should then automatically move to an internal investigation phase (conducted either by an expert or a team of experts). The third and final step culminates with a resolution of the issue as approved by the appropriate manager. Additional customizable forms tailored to suit the company's special needs should also be available.
Organizations doing business in regulatory environments require an electronic system that is designed to meet their regulatory needs. Companies subject to ISO and FDA guidelines cannot ignore customer complaints. They are the ultimate indicators of product/service quality. Every complaint has to be properly evaluated, investigated, and corrected. For instance, the FDA’s 21 CFR Part 11 requires an audit trail as a key control in making electronic records reliable. Customers subject to such regulatory standards require a secure, time-stamped audit trail that documents the identity of anyone who creates, modifies, or deletes an electronic record (such as a sample customer complaint file), when the action occurred, and the changes made to the record. If your organization is subject to regulatory compliance, there are many systems on the market that are specifically engineered to facilitate compliance with regulatory requirements like FDA standards and guidelines such as ISO 9000, ISO 14000, and ISO 13485. A good system should not only help you attain FDA and ISO compliance, but should also help you sustain it year after year.
Advanced reporting capabilities that are built into quality software should increase management oversight and demonstrate appropriate controls to regulatory agencies. High-caliber software solutions designed to manage customer complaints should include the following types of reports:
- Complaint summary
- In - process customer complaints
- Complaints categorized by type, product, and department
- Trending categorized by complaint type, product, and department
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