Automated Federal Submissions of a Global Pharma Provider

November 3, 2017

Need

To conduct gap analysis and meet the operational efficiency of Submission Management Application that can also comply with the FDA submission document standards.2

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.
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