Beyond computer validation - a new role for quality assurance in systems development

The Quality Assurance Unit (QAU) at Eli Lilly and Company is involved in the development of a new clinical pathology computer system in conjunction with the information systems area and the user area. This is the first time that the QAU had the opportunity to build our requirements into a new computer system. This is a new role for QA and includes both auditing and validation personnel who offer QA insights into issues. Benefits of QA involvement in the developmental process include saving time by building quality checks into the system, thus eliminating the need for manual review later in the process. Early resolution of issues leads to significant financial savings. Other benefits include improved communication among the three functional areas and a better understanding of the requirements and work processes. The team approach to the development of a new computer system results in a high-quality final product which meets all user and regulatory requirements, while also providing additional benefits to our organization.