Jeff Mazik, Vice President, Life Science Solutions, AssurX
If you have been procrastinating on setting up electronic submissions for your adverse event reports to the FDA, you might want to reconsider that decision. Earlier this year, the FDA published its final rule on MedWatch/eMDR reporting. Although not much has changed in this final rule in regard either to required content, the submission process, or submission timelines, the FDA has taken a large step closer to mandating 21st-century technology. The final rule states that all required adverse events are to be submitted electronically by August 14, 2015. The clock continues to tick…
Not sure if you’re handling this new reality properly? Well, here’s a quick way to find out.
Are you (or your management) making any of these statements:
“The FDA always delays, we will just wait and see.”
FDA has shown no indications of changing or extending this electronic submission requirement timeline. Their hardline stance is mostly due to the fact that electronic submissions of the MedWatch form via electronic means (through their ESG) has been available for many years on a voluntary basis. Numerous manufacturers have taken advantage of this technology over the last number of years to streamline adverse event reporting. Soon, the electronic submission process for these reports becomes mandatory.
“We don’t submit a lot of complaints, we will just wait until we have something to report.”
Maybe your company does not have many adverse events to report…maybe only once in a blue moon (great for you!). However, if you wait until a complaint occurs (after August 14, 2015), and the complaint results in a reportable event that requires submission, you are caught in a very dangerous game of Russian roulette. You see, an electronic account is required to be set up prior to an eMDR submission. FDA has previously stated that the setup of an account takes between two-to-six weeks (not counting the form completion process and ensuring all was filled out correctly). Now, depending on the adverse event, you will have between five to 30 days to officially submit it to the FDA, electronically. With a two to six-week wait on an account, you will be caught in a waiting game that in all likelihood will make you non-compliant. That’s not a good place to be.
Don’t get caught in this game where you are most likely going to lose. There are options available to do this submission electronically in a secure, managed, workflow-driven environment.
“Ok, I’m convinced, what options do I have for submitting electronically?”
If you already submit your adverse events to the FDA electronically, there is nothing you need to change. However, if you do not and are still submitting via paper/PDF, now is the time to start investigating your options. Although the FDA provides the eSubmitter tool to help you submit the reports electronically, it does not integrate with your electronic quality management system, provide electronic signature approvals, a workflow process, KPI measurements, or the like. In many cases, users will be required to re-key or copy/paste data from their original source. This error-prone, non-integrated solution leaves much to be desired, but it does serve as a quick and easy way to submit the completed report.
AssurX eMDR Process
A better, more integrated business model is available, however. AssurX, a leading EQMS provider, has for many years offered a low-cost standalone eMDR electronic submission solution. Furthermore, it can optionally be fully integrated into a complaints management workflow solution for your business, providing electronic reviews and approvals, tracking tasks, generating email notification and escalations, as well as identifying trends and tracking key performance indicators for your business. Either of these AssurX solutions can be implemented on-premise, or in a privately hosted “cloud” solution that allows you to implement more quickly and with lower start-up costs.
It’s time. Get started now.
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