Company: Gilead Sciences
Liaison(s): Bruce Kisner
Gilead Sciences is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines primarily for antiviral and cardiovascular conditions and respiratory diseases. The objective of the Gilead Work Order (WO) TMP was to improve the accuracy and efficiency of warehouse and manufacturing operations, including data entry, to ensure real-time issuance of components for the operations at the San Dimas site. Our project, the fourth phase of an ongoing Gilead program, was titled Bar Code Automated System—IV (BCAS IV). Incorporating dcLink, JDEdwards and Optio Software, we designed a software program that would barcode and automatically generate a WO. Our TMP also created a revised WO format using feedback received from user interviews and developed and tested test scripts which were used to validate the new system that was implemented. In addition, we developed several important scripting and verification documents including the User Requirements Specification (URS), Functional Requirements Specification (FRS), Validation Master Plan (VMP) and several Standard Operating Procedures (SOPs). Finally, we successfully validated the software system and transitioned this system into manufacturing and production processes within the San Dimas facility in April 2008, also known as our “Go Live” date.