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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
PubMed
Summary
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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:

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  • 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.