| This thesis presents the effective use of quality assurance techniques in the validation of computerized clinical data management systems under the Food and Drug Administration (FDA) regulation. The business user is defined as the internal customer. The FDA is defined as the external customer. The product is defined as the computerized system, which supports the mission of any life sciences organization that develops and commercializes new medicines and treatments. Significant costs are associated with the acquisition, operational use, and maintenance of these systems.; The FDA regulatory framework on computer validation is examined to understand its ability in accepting data of highest quality and integrity, and its authority in safeguarding public health. The business user is ultimately responsible for defining requirements, identifying risks, and accepting the system for end use. Key elements of the system: characteristics, requirements, risks, testing, and test coverage are examined to determine the extent of validation. |
