Root Cause Submission

June 20, 2023

Process Impacted

Manufacturer – Data Systems

Root Cause of Exception - Type

Other Data Systems

Root Cause of Exception - Description

Systems take long time to process incoming shipment data queue and hence TI/TS data trigger is delayed.

What type of exception did/would result from the root cause? - Type

Product, No Data

What type of exception did/would result from the root cause? - Detailed

Incoming shipment data are processed first in first serve basis and processing errors or delays cause delays in triggering the DSCSA TI/TS data to customers

How frequently can the root cause be expected to occur if preventive action is not taken?

Frequently (daily, weekly, monthly)

How broad is the expected impact of the root cause?

Very Broad (e.g., likely to cause exceptions for entire lot or shipment)

What preventive actions can be taken to reduce the likelihood or impact of the root cause?

Expedite shipment data processing by speeding up data processing, automatic error management, continuous monitoring of pending data queues.