An Integrated Approach to Analytical Instrument Qualification and Computerised System Validation in Analytical Laboratories

Analytical instrumentation used within regulated analytical laboratories is computerized either via firmware inside the instrument or via a PC workstation with control and application software installed on it. Qualification and validation are typically considered as separate activities with little if any interaction between the two disciplines. The major problem is that you cannot validate the computer system without qualifying the instrument and vice versa. The use of separate approaches impacts the resources needed to establish regulatory compliance. An integrated approach will enable a more efficient and effective use of such resources. This book is based upon a successful two part workshop given by the authors that will address these concerns.

在受規管的分析實驗室中使用的分析儀器通常是通過儀器內部的韌體或安裝在個人電腦工作站上的控制和應用軟體進行電腦化。資格驗證和驗證通常被視為兩個獨立的活動，兩者之間幾乎沒有互動。主要問題是，您無法在不對儀器進行資格驗證的情況下驗證電腦系統，反之亦然。使用分開的方法會影響建立法規合規所需的資源。整合的方法將能夠更有效地使用這些資源。本書基於作者所提供的成功的兩部分研討會，將解決這些問題。