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Complaints Handling
 Complaints Handling is one of several quality processes that is included in the Quality Management module. An out-of-the-box complaints form is provided, however many companies prefer to recreate their existing complaints form using Quality Manager’s configurable forms tool.
Moving to an electronic system provides a centralized repository for all complaint documentation that makes search and retrieval easy, storing all subsequent documentation pertaining to investigation and correction of the problem. It also ensures a timely resolution to customer issues; this helps companies ensure industry and regulatory compliance, improve product quality and reduce costs associated with customer complaints.
Quality Manager provides advanced tracking capability every step of the way, from scheduling and planning to execution to completion. Since it is part of the Quality Management module, it can be integrated with CAPAs, investigations, nonconformance, or any other quality process. The processes are connected within the system and reports and/or trend alerts can be set so managers are never out of touch with their quality processes.
 Forms capture complete information about a complaint, including customer information, product identification criteria, sample returns, and complaint type (such as inquiries). Quality Manager enables you to make rapid, informed decisions about complaint validity and resolution strategies.
A coding system is available to help assess the risk of the complaint. The task manager ensures proper closure by tracking verification of the response to the finding. Tasks are automatically sent via email to Outlook or other email systems, so users do not need to be logged into the system to be up to date on their workload. Any recurring complaint-related activities can be included in a task profile, however users have the option to add tasks on an ad-hoc basis to individual complaint events. Quality Manager automates task assignment and follow-up via automatic e-mail notification. It incorporates escalation capability for any task not completed by deadline.
MedWatch Form – For FDA-regulated companies, a customer complaint may result in an adverse event, which in turn requires the reporting of the FDA's MedWatch 3500A form. Once this determination is made, Quality Manager can be configured to automatically launch the MedWatch 3500A form filled in with the pertinent information from the event, reducing redundant data entry.
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Title21 Software’s Complaints Handling:
• Meets 21 CFR Part 11 requirements with a signature manifestation that includes name, date, time, and meaning of electronic signature (reviewed, approved, rejected, etc.)
• Decreases time spent tracking down pieces of information; a central repository allows for easy search and retrieval
• Allows companies to become virtually paperless
• Is part of the Quality Manager Module, so other quality events such as CAPA, deviations, investigations are linked to ensure compliance with FDA regulations and ISO quality standards
• Integrates with the Document Control and Training Modules to create a “Closed Loop” Quality Management Solution
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Some of the reports available include:
Complaint Summary: Gives a top-level view of all the complaints in the system, categorized by owner and department.
Complaint Detail: Complaints categorized by type, product, and department.
Findings by root cause.
Complaints by Owner: Lists complaints categorized by owner within specific date ranges.
Open Complaints: Lists open complaints categorized by owners with target close dates.
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