Customer Complaint Process

MasterControl software automates all tasks pertaining to the customer complaint process, including notification, follow-up, and escalation of overdue assignments. Automation helps simplify the compliance environment, making it easier to stay compliant.

This best-practice customer complaint process is incorporated in a pre-configured, multi-page form that starts with the processing of a customer complaint, automatically moving to the internal investigation step, and culminating with a resolution of the issue.

All documents related to customer complaint processes will be stored in a secure, centralized repository, making it easy to search and retrieve them during an FDA inspection or an ISO audit.

MasterControl's advanced analytics and reporting capability increases management oversight and demonstrates appropriate controls to regulatory agencies. The customer complaint process includes the following customizable reports: complaint summary; in-process complaints; complaints categorized by type, product, and department; trending categorized by complaint type, product, and department.

A customer complaint process may turn out to be the reporting of an adverse event, which comes with its own set of regulatory requirements. This solution includes the FDA's MedWatch 3500A form for mandatory reporting of adverse events, allowing a seamless handover to an adverse events specialist while ensuring that all required data is immediately collected.

Provides a secure, time-stamped audit trail as required by 21 CFR Part 11 for the customer complaint process. MasterControl documents the identity of anyone who creates or modifies an electronic record, when the action occurred, and the changes made.

MasterControl ensures that only the current version of a document is available.