Regulatory Reporting

Electronic Regulatory Submission Capabilities

Sparta Systems has developed a platform to support various regulatory reporting needs on a platform called eReporting.  The needs for submitting various reports and forms of electronic data to regulatory bodies differs from industry to industry, and is dependent on the agency and country you are submitting your data.

What is Sparta Systems’ eReporting?

It’s an electronic submission manager to facilitate transmissions of reports and data to regulatory authorities with information that is captured in the TrackWise Quality Management System.  Automating the electronic submission process can save time and costs related to the submission process.  Processes that can take several days, can now be managed in under an hour.
 
The eReporting platform is equipped with capabilities to integrate with Sparta’s quality management processes, such as complaint and adverse events, in order to export out the necessary details into an electronical format that can be packaged and sent to the regulatory body. Typically, receipts and acknowledgments will be returned back to the eReporting platform which will be processed and recorded on the TrackWise record to ensure a proper level of visibility and communication is observed.
 
In the Medical Device industry, you will be required to submit UDI information to the FDA’s GUDID system and adverse event related information to the FDA’s Center for Device and Radiological Health (CDRH) which is known as eMDRs.  When submitting in EMEA, you’ll be sending eMDV files with adverse event information to the various countries in which you sell your product.
 
In the Pharmaceutical and Biotech industry you may need to submit your adverse events to the FDA in the form of an Individual Case Safety Report (ICSR – E2B).  This is sent electronically, to the FDA’s Center for Drug Evaluation and Research.  Upcoming submission types may include submitting quality metric data to the FDA.

What Submission Types are Available with eReporting?

For more detailed information, please select the desired regulatory reporting type:

  • eMDR – Electronic Medical Device Reporting
  • eMDV – Electronic Medical Device Vigilance (MEDDEV)
  • UDI – Unique Device Identification
  • Drug Safety – ICSR E2B – Individual Case Safety Reports
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