Title: A technique for retrospective computer validation of drug manufacturing software

Authors: Masakazu Takahashi

Addresses: Interdisciplinary Graduate School of Medical and Engineering, University of Yamanashi, Takeda 4-3-11, Kofu, Yamanashi 4008511, Japan

Abstract: This paper proposes a technique for validating that in-service Drug Manufacturing Software (DMSW) is adequate. This technique is called Retrospective Computer Validation (RCV). When conducting RCV for the first time, one validates the adequacy of DMSW|s functions and performance by collecting existing documents and operational records. When we use RCV-conducted DMSW, some modifications occur. In this case, modification of documents and enforcement of additional tests are required. However, it is difficult to secure consistency between existing and newly developed documents and to conduct exhaustive tests of areas affected by modifications. This paper proposes the following solutions: preparation of document architecture, definition of document templates, management of design information using database, establishment of a technique for identifying and testing the range of DMSW affected by modified parts and definition of RCV procedure. As a result, we can conduct adequate RCV and prove that the DMSW is of a high enough quality for manufacturing drugs.

Keywords: retrospective computer validation; drug manufacturing; development document; software testing; document architecture; document templates; design information.

DOI: 10.1504/IJCAT.2009.026591

International Journal of Computer Applications in Technology, 2009 Vol.35 No.2/3/4, pp.139 - 149

Published online: 20 Jun 2009 *

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