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.