With ComplianceQuest’s automated decision tree and regulatory reporting capabilities, the process of submitting a complaint to the FDA or other regulatory authorities saves valuable time for both the quality and regulatory affairs (RA) team. And with our recent product update, CQ’s Complaint Management solution offers a fully integrated MDR eGateway, to automate the process of submitting eMDRs to the FDA. It’s so easy that submitting an eMDR to the FDA takes only one click.
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ComplianceQuest is a registered FDA Transaction Partner for eMDRs and supports the latest XML, HL7 R3, ICSR R2, and AS2 protocol with client digital certificates. The MDR eGateway enables the following four key benefits:
Reduces complexity and streamlines the workflow
It eliminates the complexity of managing multiple servers and IT infrastructure in transmitting reports and attachments and receiving acknowledgments through the FDA Electronic Submission Gateway (ESG).
Automatic XML file generation
For high volume complaints, it helps increase the speed of reporting by automatically generating the appropriate XML file(s), and then with 1-click, transmits it to the FDA ESG FAER database including attachments and any follow-up reports.
Automated acknowledgments and submission status
All acknowledgments and errors are captured in the Complaints record and automatic alerts are sent to appropriate personnel about any failures or messaging errors.
By eliminating the need to submit files through the FDA’s eSubmitter, it reduces the manual effort for the quality team and improves efficiency and productivity.
From an overall business perspective, receiving too many of the same complaints — can lead to audits, fines, and reputational risk for medical device companies. It is, therefore, paramount to do whatever it takes to learn from past complaints and take necessary steps to prevent future occurrences.
Benefits of a Truly Next-Gen Complaints Management Solution
As a quality leader, you would be looking to minimize the number of complaints as much as possible. But if things do go wrong, customers may complain. When that happens, it is important to act with agility, resolve the complaint and take steps to avoid the same mistake in the future.
However, several companies across sectors often struggle with the following:
- Act swiftly to resolve a complaint and deliver a solution to the customer as soon as possible
- Prevent repeat occurrences of the same mistakes
- Use complaint data for risk management
- Take corrective and/or preventive actions with agility and nimbleness
- Collaborate with key stakeholders, across teams, to resolve a complaint
- Derive insights for the future from complaints data
- Collaborate with a supplier, when resolving a complaint requires their support
Additionally, in regulated sectors like medical devices, handling regulatory submissions around complaints is a major challenge and adds complexity to the whole process. Understanding these difficulties, the MDR eGateway was a major update for us to be able to meet our customer requirements in a more holistic and effective way and providing a path to digital excellence.
Looking to truly automate the process of high-volume complaints (eMDRs) to the FDA? ComplianceQuest’s next-generation EQMS now offers a fully integrated MDR eGateway. Request for a demo here: https://www.compliancequest.com/online-demo