Abstract

QAAMS (Quality Assurance Audit Management System) is the product of a partnership between the Rhone-Poulenc Rorer R&D Quality Assurance and Telos Bioinformatics. At present few pharmaceutical companies have decided to tackle the challenge of fully computerizing their QA activities (1,2). In a first article published in this journal, the rationale behind the system and the method of development were discussed. In this second article details are provided on the system use and features. The system capabilities are described and examples of the reports generated are provided. Throughout the article, I have had two objectives in mind while describing the system. Firstly, to highlight the numerous benefits and interesting possibilities which QA professionals will find in the system. Secondly, to demonstrate that, although the present tool was initially designed for use in a GLP QA environment, the system is very adaptable and will be of benefit to a much broader range of QA professionals working in compliance with other reference standards (GXP, ISO 9000 etc.).

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