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Beyond computer validation - a new role for quality assurance in systems development
C A Thompson1, L A Kramer, R W Usher
1Eli Lilly and Company, Quality Assurance (Toxicology) and Scientific Information Systems (Toxicology), P.O. Box 708, Greenfield, Indiana 46140, USA.
Quality Assurance (San Diego, Calif.)
|June 1, 1995
Summary
The Quality Assurance Unit (QAU) integrated quality checks into a new clinical pathology system development. This proactive approach saved time, reduced costs, and ensured regulatory compliance.
Area of Science:
- Clinical Pathology
- Information Systems
- Quality Assurance
Background:
- The Quality Assurance Unit (QAU) traditionally audited systems post-development.
- A new clinical pathology computer system required development involving multiple departments.
Purpose of the Study:
- To integrate QA expertise early in the development lifecycle of a new clinical pathology computer system.
- To leverage QA insights for building quality into the system from inception.
Main Methods:
- QA personnel (auditing and validation) collaborated with information systems and user areas during system development.
- QA requirements were incorporated directly into the new system's design and build phases.
Main Results:
- Building quality checks into the system eliminated the need for later manual reviews, saving time.
- Early issue resolution and proactive quality integration led to significant financial savings.
- Improved communication and understanding among the three functional areas (QAU, IS, User).
Conclusions:
- Early QA involvement in system development is beneficial for creating high-quality, compliant systems.
- A collaborative, team-based approach ensures the final product meets user and regulatory needs.
- Integrating QA early offers organizational benefits beyond just system quality.