Project Abstract

For an international pharmaceutical company, developed the functional system specifications, application and database design, user documentation, user test plan, test scripts, implementation and validation plan for the Drug Sample Tracking System.  This system manages all samples in the laboratory.  System functionality permits users to manage notebooks where sample data is recorded, manage logbooks where instrument data (such as calibration and repairs) is recorded, and maintain eleven reference tables (including products, dosages, etc.).  Standard system reports are based on sample analysis.  The system can also produce labels, information sheets and status reports for each sample.

 Of particular note with this system is the comprehensive and easily accessible audit trail.  The system administrator can access the complete history of any specific record using the Log button associated with each data window in the system.  This audit trail is essential in complying with FDA requirements.  The Drug Sample Tracking system was written in VISUAL BASIC 6.0 using ADO to access an ORACLE database.