Through innovative thinking, ZAI conceptualized and re-engineered the business process for submission of drug applications, conducted a requirements analysis, and designed a system to fully automate submissions for FDA. The Electronic Document Room (EDR) was born. This system allowed the FDA to meet Government Paperwork Elimination Act (GPEA) requirements a full year early. Today, drug applications are received electronically, replacing the need to process and store 50,000,000 pages annually. These submissions are processed, analyzed for conformance to FDA submission guidance, mounted on the network, and cataloged.

We established procedures for receipt of electronic drug applications and assisted FDA in developing new regulations. ZAI has developed, implemented, and migrated numerous systems. We:

• Tested and helped implement the Division Filing System to automate letters and evaluations through the FDA network, eliminating the need to process hundreds of thousands of paper records annually.
• Assisted in the design, testing, and implementation of the Electronic Charge and History System, resulting in automated workflow tracking and elimination of paper tracking.
• Assisted in the transition to a scanning and file storage Drug Master File System that enables electronic submission review.
• Led the design of an Electronic Document Management System (EDMS) to handle precedent files.