Need

To conduct gap analysis and meet the operational efficiency of Submission Management Application that can also comply with the FDA submission document standards.

Solution

• Developed an intranet site that could be accessed by submission groups worldwide.
• Integrated with Documentum based repository
• Developed capability to check for correct formats of documents using MS Excel, MS Word and PDF automation interfaces
• Developed a load balancing architecture to improve performance for Word, PDF and XLS automation.

Outcome

• Set established standard for Submissions group.
• Increased the efficiency as well as accuracy of Submission groups by automating processes
• Tool integrated with existing Documentum based system that can track the document lifecycle.