Product complaint management and root cause investigation
Develop a robust complaint management process.
At ZebraSci, our complaint management expertise goes beyond basic practices – we assess and conquer a wide range of challenges associated with combination products and primary containers. Our experienced team assists in developing a robust and rapid clinical and/or commercial complaint handling processes, from intake and decontamination to in-depth root cause investigations, corrective actions, and trending.
At ZebraSci, we can establish end-to-end market complaint programs with customers where we receive market complaint samples, decontaminate them, and execute a protocol to determine the comprehensive root cause of the complaint.
Our expertise includes an in-depth analysis of each feature and potential failure mode to ensure that we aim the problems accurately. We take a tailored approach with a versatile state-of-the-art toolkit to ensure that your products are brought to new heights of quality and performance.
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Sample strategy, management and decontamination
Sample strategy, management and decontamination
- ZebraSci has the ability to receive and handle biohazard products for complaint/ root cause investigation purposes directly from the ‘field’. Moreover, ZebraSci can develop documentation to assist in the investigative analysis of complaint samples (both biohazardous and non-biohazardous). ZebraSci can develop decontamination procedures as well as handle the decontamination process. Whether a customer needs assistance with a small-scale decontamination task or a large-scale complaint management project, we are equipped to meet our clients’ needs.
Defect library creation
Defect library creation
- ZebraSci can support customers with creating a defect library and managing complaints trending. Additionally, by leveraging our internal defect library and expertise with drug delivery devices failure modes and root cause investigations we can promptly support and address specific complaints in the field, leading to a more efficient and satisfactory resolution for your customers or regulatory agencies.
Protocol and inspection process development
Protocol and inspection process development
- ZebraSci has the expertise to develop detailed protocols and step-by-step instructions for handling complaints and root-cause investigations. Our team will work closely with you to ensure a thorough and accurate investigation, identifying root causes and implementing corrective actions to prevent future issues. Our labs have state-of-art equipment and analytical tools that will assess your products in-depth and advise on design flaws, process issues, or potential human error during product use.
Tight timeline and expedited turnaround
Tight timeline and expedited turn around
- In the medical/pharmaceutical industry, time is of the essence when it comes to resolving market complaints or submitting them to regulatory agencies. That’s why ZebraSci offers expedited turnaround on complaints investigations. With our efficient processes and dedicated team, we prioritize urgent cases to provide swift resolutions without compromising on quality, accuracy, and compliance.
Investigation reports
Investigation reports
- Our team at ZebraSci will create comprehensive documents (reports, memos) that will highlight all relevant details of the complaint, investigation, and final resolution or recommended corrective actions. These memos and reports serve as valuable records and can be instrumental in improving your organization’s processes and customer satisfaction levels. ZebraSci operates under a strict, internal Quality Management System; audited by the FDA and other organizations; therefore, this documentation can be used as official records.