U.S. Food and Drug Administration Implements GlobalSubmit 2010 to Review and Validate all eCTD Submissions
GlobalSubmit Inc., (www.globalsubmit.com) a provider of end-to-end software and services solutions for delivering high-quality electronic submissions to regulatory authorities, announces that the U.S. Food and Drug Administration (FDA) has installed GlobalSubmit 2010 and is using the software in production to review and validate all eCTD submissions. The release includes several performance enhancements and positions the FDA to receive all submissions electronically.
The FDA is a unique partner with over 4,000 users and more than 200,000 sequences processed. The driving forces behind the FDA’s adoption of the software update were the availability of the latest Study Tagging Files (STFs) valid values, new validation checks, and new views. The FDA looks at GlobalSubmit’s validation reports to determine if sequences are reviewable. Therefore, the use of GlobalSubmit’s validation platform helps sponsors create higher quality sequences.
Cognizant of the FDA’s present and future needs, as well as the increased adoption of electronic submissions industrywide, GlobalSubmit’s latest release incorporates the following performance enhancements:
- Ability to load several thousand sequences a day (current workload is 600 sequences a day)
- Ability to load 200,000 sequences in two weeks
- Ability to prioritize which sequences are loaded first (load priority reviews first)
- Analyze validation reports with different views
- Have a log of every sequence that received a technical rejection
- Effectively prioritize sequences and help to determine where there are errors
“Our main goal with this release is to enable clients to create high-quality submissions quickly and simply,” stated Jason Rock, GlobalSubmit’s chief technical officer. “When we first introduced GlobalSubmit 2010 we were able to load four sequences a minute, or 5,500 sequences a day. This would have taken the FDA about a month and a half to process all of their existing sequences.
“Now we can process 30 sequences a minute, meaning the FDA can process all submissions in less than a week, or over 40,000 sequences a day,” he added. “The combination of our powerful functionality and enhanced performance has helped turn our goal into a reality, and we look forward to rolling out this latest
version to our clients.”