Validation: From Theory to Practice,a Quality Assurance Perspective

Abstract

This article aims at evoking the questions that can be raised by quality assurance professionals in the tentative implementation of a validation scheme that complies with good clinical practice (GCP). Preclinical departments have long benefited from well defined strict good laboratory practice (GLP) requirements in this area and also from the complexity of their working environment with machine to computer links. Quality assurance should be implemented as early as possible in the development plan. Quality assurance, by definition free from stringent time and financial constraints, can at first be time consuming and costly, but in the long run it will guarantee the integrity of the database. The role of quality assurance should be to demonstrate that all necessary questions have been raised and that answers have been given. Three examples of new applications in the handling and transfer of complex data and the questions they can raise in terms of assuring that they do perform the intended task with a confident level of reliability are envisioned.