Total Quality Management of Clinical Trial Supplies

Abstract

Validation of process automation creates challenges for laboratory directors, quality assurance units and regulatory authorities. The complexity of modern computer systems lies in the software which directs tasks. Direct examination of small software modules can be used successfully by software vendors. Visual examination of reports produced by different programs can demonstrate that values are identical on all reports.

Complementary function testing is another technique used to validate software systems. When changes are made, revalidation is required. Laboratories can revalidate using test data and automatic exception reporting. Testing is a technical and time consuming task, but one that must be carried out to help ensure confidence in automated processes and reports.