Analytical Instrument Qualification and System Validation (Primer)

Qualification of analytical instruments and validation of systems is required by many national and international regulations, quality standards such as ISO 17025 and company policies. If executed correctly, it also helps to improve instrument uptime and to avoid out-of-specification situations (OOS) in laboratories. This “Analytical Instrument Qualification” primer guides analysts, laboratory managers, quality assurance managers and validation professionals through instrument and system validation at minimal extra cost. The concept, examples, templates and recommended procedures are based on my more than 20 years of multinational experience and incorporate knowledge from validation and qualification practices applied at Agilent Technologies and Labcompliance. Readers of this book will learn how to speed up their validation and qualification process, thereby avoiding troublesome reworking and gaining confidence for audits and inspections. Due to limited space, I could not include all the information that is available and of interest to readers. For additional information, I can refer you to three text books:

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