What are businesses doing today for their FDA complaints submissions?
- Outsourcing the process of building the solution and then maintain it internally with their IT staff (this is expensive)
- Use the free WebTrader (this is manual and inefficient)
- Outsource to expensive e-MDR services in case of high volumes (this is not ideal because you are reliant on a third party)
Pain points for the Regulatory Team
- Lack of real-time visibility into the performance of e-MDR submissions
- Risk of non-compliance (filing error or late submission)
- e-MDR submission is a labor-intensive task for the regulatory team
The need: An efficient solution that reduces the need for more people, while also ensuring compliance. It must also be a solution that provides visibility to the quality team.
Pain points for the IT Team
- Internal team might not have the expertise to develop a B2B solution
- High level of support needed for the internal system
- Out-of-the-box solutions might be too expensive
The need: A simple, cloud-based solution that reduces IT costs and the need for resources.
ComplianceQuest ensures that your e-MDR filing is always streamlined with no hassles. Download this whitepaper to understand how CQ’s e-MDR gateway can be the perfect solution to truly automate the process of high-volume complaints (eMDRs) to the FDA.