quality assurance

Wrote System Overviews, System Configurations, and System Detailed Design Specifications for 21CFR11-compliant Data Historian Systems commissioned in an FDA regulated pharmaceutical production environment.
Generated Installation and Verification Instruction (IVI) and Operational Qualification (OQ) Test Cases to qualify the installation, configuration, and operation of Data Historian System software. These documents complied with guidelines and procedures of the following Eli Lilly entities:
- Manufacturing and Quality Informatics (MQI)
- Global Data Availability (GDA)
- Enterprise Systems Management (ESM)
- Corporate Computer Systems Procedure CCS-RAD-CPR-01, Requirements and Design
- Computer Systems Quality Policies and Procedures
- B105 Parenteral Plant Good Manufacturing Practices (GMP)
All of the above documents were generated two Production Data Historian Upgrade Projects and an Off-Site Test Facility Project.
Installed, configured, and tested software on Production and Off-Site Test Facility Data Historian Systems in compliance with IVI and OQ test cases and procedures.

Developed documentation and reporting templates for ISO 9000 compliant software development for Custom Software Services group.
Developed Microsoft Office/VBA and Access/SQL database applications to automate reporting required for ISO 9000 software development process, and to provide tracking of ISO 9000 procedures on software development projects.