Electronic Batch Record System (Bristol-Myers Squibb)

Designed and implemented a system for tracking, recording, and archiving all aspects of the (What Product?) manufacturing process as required by the FDA. Using VB/C#, ASP.NET, and PL/SQL stored procedures, the system tracked batch/lot status, operator inspections, inventory and raw materials usage, rework, and supervisor approvals. The system was compliant with 21 CFR-Part 11 requirements for data encryption, traceability, and electronic signatures.