CHALLENGE: Client, a large blood products manufacturer, implemented a new blood test called Nucleic Acid Testing (NAT). Project included development of nine new information technology systems, the startup of a new laboratory (including the training, staffing, equipment and procedure development), and FDA regulatory compliance. ProFicient was hired to lead a management support team to plan and manage development of several complex blood manufacturing procedures and training for hundreds of employees nationwide.
APPROACH: ProFicient developed and updated a complex project schedule with over 500 tasks and dozens of task managers. ProFicient produced monthly reports to managers and staff on project status. RESULT: A successful project, with over 90 percent of project tasks completed within 6 months. The project remained on schedule despite a high turnover rate in the client's core management team. Over 6 million donations tested annually. Several competitors have adopted this testing approach and the client project manager received a company award for excellence in project management. The client retained ProFicient for a second NAT development project in 2001.
Fast-Track Manufacturing Process Change
CHALLENGE: Fast-track modification of manufacturing procedures and information systems to comply with FDA mandate within 6 months. APPROACH: ProFicient applied project management software and tools, performed analysis, made recommendation for enhancement of business processes, and both authored and reviewed documentation required to support the project. RESULT: All four laboratories are currently in operation. Project goals were met on schedule and under budget.
Blood Testing
