Cause of the issue during the migration of biohorizon¿s account from development to production, the fda gateway was mapped to emdr form version 2015 instead of 2021.The incorrect mapping to form version 2015 resulted in the submissions failing to move through the fda gateway.Impact the records impacted were stuck in "submission in progress" state causing them to not advance to the fda.Impacted records count 480 emdr records out of a total 1238 emdr's in the system.Corrective actions biohorizons: biohorizons is issuing a supplier corrective action request (scar) to our vendor sparta.This will allow biohorizons to formally document the issue, actions taken by sparta to correct, and along with sparta actions taken to prevent the reoccurrence of this event.Scar number (b)(4) was issues to sparta to document the event.Sparta: to resolve the issue, sparta corrected the emdr form version mapping to 2021 for the biohorizons production account.The fix does not retrospectively re-submit the impacted records to the fda.To accomplish this additional step are needed to re-submit the impacted records to the fda.These steps are: 1.Update the mdr submission status on each record to a blank value.2.Update h10 field with mfg narrative for the late submission.3.Using trackwise digital platform automation, progress the impacted records to "failed fda" 4.Using trackwise digital platform automation, progress the impacted records to "submission in progress fda" preventative actions this sequence of events which led to the issue will not occur again for biohorizons because the emdr form version mapping is a one-time activity.During the time of production deployment, biohorizons was a new customer of sparta.Sparta has raised the event to the product organization in exploring the options to remove any retired fda form references from the system.One of the options is for new customers to remove the old form version and verify the current fda version is appearing within the new customers production environment.Moreover, to facilitate early identification of fda submission issues, a report will be built to identify emdr records in "submission in progress" state for a defined period of time.
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