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.
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.
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.
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.
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.