Sample Customer Complaint

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.