FDA has provided an informational notice to NTEU stating that the Office of Regulatory Affairs (ORA) will begin testing various computer applications in preparation for the transition to Program Alignment, after the parties have completed negotiations regarding Program Alignment.
According to the informational notice, ORA IT teams are currently working on application changes to support the new ORA organizational structure and will be reaching out to application users in the field to participate in User Acceptance Testing (UAT) and provide feedback to the agency. Participation is voluntary. The agency contends that changes to the applications will not affect the day-to-day work of the users; however, the changes will reflect the newly proposed organizational structures and reporting hierarchies under Program Alignment. The application teams will develop user testing scenarios and provide test data. The UAT participants will rate each scenario as a pass or fail and will be provided a template to report software issues to the application teams.
I welcome and encourage your questions and comments on this subject.