Software Validation for Medical Device Manufacturing

Abstract

The recent guidance on 21 CFR 11, the upcoming deadline for European CE Marking, and the needs of quality system regulation (QSR) have generated much discussion about approaches to software validation. In this article, a view of software validation by the design team of a QSR medical device manufacturer of precision glycohemoglobin/hemoglobin variant high performance liquid chromatography (HPLC) instrument platforms is provided. The software includes manufacturing, accounting and customer modules in one application. The unique aspect of this manufacturer's approach was to start with a risk analysis and a quality assurance audit plan to check software modules. The article also shows how a quality assurance unit should be prepared to contribute regulatory expertise for software validations that incorporate GMP, ICH, GLP, ISO and accounting standards. Copyright © 2003 John Wiley & Sons, Ltd.