ZAI is ISO 9001:2008 certified
ZAI maintained and performed systems enhancements for all production and distribution IT systems for FEMA’s Mitigation Directorate’s Risk Analysis Division. We managed full system lifecycle implementation from requirements identification through maintenance in developing and implementing these systems, system components, and major enhancements. Systems in production were maintained and enhanced according to user requirements.
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.
When ZAI began working with FDA more than 20 years ago, paper records were the norm. Since that time, we’ve been developing efficient and innovative solutions to help manage electronic document processes. ZAI has worked behind the scenes to enable drug submissions to move efficiently through FDA’s systems, while increasing public safety through information management.
ZAI operates the centralized Document Management Center (DMC) for the Pension Benefit Guaranty Corporation (PBGC) which is charged with protecting the pensions of 44 million American workers and retirees. The DMC processes more than 1.5 million documents per year.
ZAI manages and operates FDA’s Document Control Rooms (DCRs) for the Centers for Drug Evaluation and Research, Veterinary Medicine, Tobacco, and Devices and Radiological Health.The DCRs are lifecycle case file management centers that receive, validate, process, and store drug applications, regulatory submissions, clinical trials, correspondence, and other pharmaceutical case records used to evaluate the safety, efficacy, and security of human and veterinary drugs and medical devices. The DCRs operate in a highly visible, fast-paced, multi-faceted, production-oriented environment that directly supports FDA’s mission.