Reinterpreting validation

Abstract

This paper briefly describes the current approach to validation in good manufacturing practice (GMP) and postulates that the main difficulty with the process is determining how much validation is enough. It asserts that the current methodology is focused on documentation rather than verification, and furthermore that the inherent problems of document management are inhibiting resolution of the main difficulty. The paper argues that a data-driven approach instead of a document-driven approach to information management has the capability of removing the document management problems and thus enabling an improvement in verification. It further argues that such an approach is timely because of the increased use of computer applications and databases in design, construction, commissioning and operations, and available standards and implementations. It is also timely because of the recent interest of the US regulatory authority (FDA) in the regulation of electronic records [1]. Furthermore, a migration path exists where documents can be produced as necessary but no longer are the master information source. Opportunities for further research are identified.