Complaints Management
The FDA requires customer complaints to be reviewed and then investigated if a discrepancy is identified. The NextDocs Complaints Management System provides a comprehensive solution to manage the recording, routing, and resolution of customer complaints.
The FDA requires customer complaints to be reviewed and then investigated if a discrepancy is identified. The NextDocs Complaints Management System provides a comprehensive solution to manage the recording, routing, and resolution of customer complaints. Configurable web-based forms manage the recording of details when the complaint is initially reported. Automated routing for investigation and resolution is initiated based on the characteristics of the complaint. The complaint can then be tracked to closure, including the automated initiation of a discrepancy if warranted. The result is a closed-loop system that can help to protect consumer safety, reduce the risk of future incidents, and ultimately shield a brand's reputation.
NextDocs Complaints Software features and benefits
| Features | Benefits |
|---|---|
| Extensively configurable electronic forms with role-based sections | Allows automation of client-defined processes and steps without customization. |
| Sections locked down upon completion and subject to only compliant modifications | Improves data integrity as users cannot change data accidentally; focuses each task on the specific actions and data required for completion. |
| Dynamic routing of workflow based upon data entered | Automates the execution of defined processes, for example, including or excluding safety or regulatory input based on the nature of the deviation; eliminates unnecessary steps. |
| Automatic assignment of tasks to predefined users, groups or roles when applicable | Ensures that tasks are handled by the appropriate users; eliminates manual tasks. |
| Automated notifications and escalations of complaints to the correct responsible parties | Provides participants with insight into assigned tasks and their statuses even when they are not logged into the system; highlights upcoming and overdue tasks. |
| Data-driven approach allowing capture of key information for reporting and trending | Insight into root cause, state of control and process efficiencies. |
| 21 CFR Part 11 compliant electronic signature | Allows efficient use of the system across physical locations and eliminates costs associated with printing, couriering and storing paper documents. |
| Detailed audit trail | Provides Part 11 compliance as well as insight into activities completed in the handling and closing of a complaint. |
| Automated process forwards tasks to designated recipients upon completion of previous tasks | Increases efficiency by decreasing the manual intervention needed to process a complaint. |
| Closed loop process | Allows automated closure (such as generation of an associated deviation) if all information is available to justify closure; if not, notifies responsible user to complete the closure process when appropriate. Reduces the risk of dropped handoffs and the associated compliance impact. |
| Efficient handling of supporting documentation such as photographs, emails, etc. | Allows access to supporting materials to support decision-making and investigation without controlled document processing unless appropriate. |