Load Testing

Per NextGen ESG AS2 Setup Instructions only a single Test Submission needed for UAT.

Prerequisites

You will need to determine what type of Load Test is required, based on the AS2 guidance below (from: Electronic Submissions Gateway (ESG) Load Test)

The Food and Drug Administration (FDA) Electronic Submissions Gateway (ESG) requires the following Load Test submission sizes based on the type of submissions you plan to send to the Gateway:

  • If you plan to send large files (1GB or more), please submit a 2 GB single file submission

  • If you plan to send many small files: (most common)

    • Please send 1 batch multi-file submission, containing 50 files and

    • Please send 1 batch multi-file submission, containing 20 files

  • If you foresee sending larger than a 2 GB submission to the FDA through ESG, then we strongly recommend that you submit a 7.5 GB Load Test submission.

  • Consider known Axway Synchrony issues when submitting large submissions.

    Sending Large (> 7.5 GB) Submissions

    Common AS2 Errors

    NOTE: Sending large submissions may result in the FDA ESG erroneously reporting that the transmission was not successful, even though the FDA ESG has successfully received the transmission. This is a known bug and FDA has asked Cyclone Commerce to provide an update that fixes this error.

Procedure

  1. Load test #1 – Using Application Number: 123456 (that is configured to Health Authority Division: Food and Drug Administration > GWTEST)

    Create and publish a new submission 0002

    • Submission Type: Product Correspondence

    • Subtype: Correspondence

    • Gateway Format: SizeTest (this must be changed from the default of ConnectTest)

    • Regulatory Contact: From prerequisites

    • Technical Contact: From prerequisites

    • Real fillable 1571 with application number and sequence fields completed and matching the test data

    • Sample cover letter

    • Attach 50 literature references

    • Note: You may choose any type of file(s). Using 50 Literature References is simple and easy to execute; the FDA doesn’t care whether or not the submission makes sense.

  2. Progress the submission to the Ready for Submission state

    From the action menu, select Submit to Gateway

  3. Verify the Dossier Status shows Transmission In Progress or Transmission Successful and Pending Acknowledgements is 1 (This should happen quickly)

  4. Expand the Attachments section of the Submission

    Open the log file that Veeva produces that starts with gateway_transmission_log

    Screenshot step 4

  5. Refresh and wait for the MDN File to be uploaded by the FDA:

    Screenshot step 5

    Open the MDN file (the first part of the file will be readable and indicate the MDN was successfully processed).

  6. Check the submission every few minutes until the expected Acknowledgements is 0 and there are a total of 3 attachments on the submission.

    Open the fda_atch_ack file and compare the following in the Dossier Details object associated with the Submission in Veeva RIM:

    • Gateway Correlation ID matches CoreID in ACK

    • Gateway Transmission ID matches Message ID in ACK

    Screenshot step 6

  7. Load Test #2 – using Application Number: 123456

    Create and publish a new submission 0003

    • Submission Type: Product Correspondence

    • Subtype: Correspondence

    • Gateway Format: SizeTest

    • Regulatory Contact: From prerequisites

    • Technical Contact: From prerequisites

    • Real fillable 1571 with application number and sequence fields completed and matching the test data

    • Sample cover letter

    • Attach 20 literature references

  8. Progress the submission to the Ready for Submission state

    From the action menu, select Submit to Gateway.

  9. Verify the Dossier Status shows Transmission In Progress or Transmission Successful and Pending Acknowledgements is 1 (This should happen quickly)

  10. Expand the Attachments section of the Submission

    Open the log file that Veeva produces that starts with gateway_transmission_log

Screenshot step 10

  1. Refresh and wait for the MDN File to be uploaded by the FDA.

Screenshot step 11

Open the MDN file (the first part of the file will be readable and indicate the MDN was successfully processed).

  1. Check the submission every few minutes until the expected Acknowledgements is 0 and there are a total of 3 attachments on the submission.

    Open the fda_atch_ack file and compare the following in the Dossier Details object associated with the Submission in Veeva RIM:

    • Gateway Correlation ID matches CoreID in ACK

    • Gateway Transmission ID matches Message ID in ACK

Screenshot step 12