Book Detail
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Medicine > Pharmacology
An Integrated Approach to Analytical Instrument Qualification and Computerised System Validation in Analytical Laboratories
McDowall, R.D.
ISBN 13: 
9781439830291
ISBN 10: 
1439830290
Category: 
Pharmacology
Edition: 
1
Publisher: 
Taylor & Francis
Publication Date: 
01/2021
Format: 
Cloth
Status: 
Not Yet Published
Imprint: 
CRC Press
Affiliation: 
McDowall Consulting, Bromley, Kent, UK
Pages: 
600
Weight: 
2
Retail Price: 
279.95 (Tentative Price May Change)
Quantity On Hand: 
0
Quantity On Order: 
0
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Synopsis:

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.


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