The FDA considers customer complaint handling an essential process for life sciences companies, as well as a critical component to assuring compliance. Whereas in less regulated industries, customer complaints may indicate mere dissatisfaction, in life sciences and manufacturing they can point to serious product safety issues. Life Sciences companies know that complaints from their patients, doctors, distributors, consumers, customers or retailers create severe brand and reputational risk. Failure to meet quality standards will result in returns, recalls, and batch wastage, all impacting the bottom line. But more importantly, adverse events create a serious risk to patient safety, can destroy the organization’s reputation and kill the product and/or the company. Patient safety is taken seriously by every Life Sciences organization and so every complaint must be properly handled.
By implementing the QUMAS Complaints Management Solution you can ensure that all complaints are captured, investigated and tracked to resolution, to the satisfaction of all stakeholders, including the regulatory agencies. By being able to conduct trend analysis of complaints in one facility, preventative actions to be put in place in other facilities, ensuring that the same issues are not repeated elsewhere. Automated forms, business rules and a dynamic workflow engine make up the basis of the QUMAS best practice process, allowing for an action plan to be created and executed to the satisfaction of the complainant. For more information on addressing Complaints using the QUMAS solution, download this webinar on Driving Business & Quality Success with an Integrated QMS Platform or check out this Complaints Process Package from the QUMAS Packaged Solutions, which offers an off-the-shelf approach to Complaints Management.
The QUMAS Complaints Tracking Solution is easily configurable to meet your organizational practices, and provides you with a closed-loop process for automating the complaint handling process and integrating it with other processes critical to regulatory compliance, such as change control, audit and CAPAs. Our solutions enable organizations to properly evaluate all complaints, automate the completion of required forms, and generate management reports. Integration with other quality management processes makes it easy to automate and enforce workflow processes in order to establish clear accountability and ensure repeatability.
- Standardize complaint handling across the enterprise
- Track complaints from initiation to completion and take a proactive approach to the complaint-handling process
- Maintain 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 - critical for 21 CFR Part 11 compliance
- Consolidate different sources of complaints such as Web form; email; sales rep escalation into one streamlined process and platform
- Automate the capture of all critical information with a customizable form that enforces escalation as appropriate, and email follow-up
- Customizable reports allow you to view complaint summaries; in-process complaints; as well as categorize and trend by complaint type, product, and department
- Controlled record-keeping documents investigations and follow-up and reduces potential legal exposure
- Integrate customer complaint handling with CAPA processes to automatically escalate serious quality problems
- Automatically link to the FDA MedWatch 3500A form if the customer complaint turns out to be an adverse event, allowing a seamless handover to an adverse events specialist while ensuring that all required data is immediately collected
- Assure a complaint is always addressed in a timely, documented fashion
- Benefit from a secure and central platform for managing customer complaints