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Give details of validating document
Because of the nature and size of this primer, all the details of operational qualification and system validation cannot be given.For more details, please refer to reference articles and text books (3-5).Before 1990 the regulatory focus of instrument and computer validation was primarily on manufacturing equipment, which changed after 1990.
After an introduction to the chapter’s approach for instrument qualification, this primer will lead you through individual qualification phases and give recommendations for implementation.
The primer will not only help readers understand the instrument qualification process, but also offers templates and examples to easily implement qualification.
The word validation relates to applications, processes and methods.
For example, for method validation we specify the limit of quantitation or limit of detection of our sample compounds.
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Validation of Analytical Methods and Procedures Conduct and Document for Efficiency and FDA, USP/EP and ISO 17025 Compliance How to Efficiently Get ISO 17025 Accreditation Step-by-step from the idea to cost-effective implementation FDA Compliant and Efficient HPLC Qualification and Testing Learn how to select, conduct and document the right tests in the right sequence How to Efficiently Build a GLP Laboratory Step-by-step from design to cost-effective implementation Here Ludwig Huber (right) in the Q&A Discussion Session on Laboratory Compliance at a ISPE/FDA Beijing University Conference with Nick Buhay, Acting Director in FDA/CDER's Division of Manufacturing and Product Quality The objective of any chemical analytical measurement is to get consistent, reliable and accurate data.Proper functioning and performance of analytical instruments and computer systems plays a major role in achieving this goal.Therefore, analytical instrument qualification (AIQ) and computer system validation (CSV) should be part of any good analytical practice.Such specifications can only be verified with a complete system and accessories such as the right chromatographic column, calibration standards and SOPs for running the test.Unfortunately, validation and qualification are frequently used interchangeably.The word qualification relates to instruments that can be individual modules and also systems, for example, a complete HPLC system comprised of a sampling system, a pump, a column compartment and a detector.Checking the baseline noise of a detector and comparing the results with previously defined specifications would be an example for qualification.There is a second aspect to why validation and qualification are important, and this is equally important for those working in a regulated and in an accredited environment.Even though frequently not directly spelled out in regulations and official guidelines, such as Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP), or in quality standards, such as the International Organization for Standardization (ISO) Standard 17025, validation and qualification is usually required.For example, for software and computer systems the term validation is always used, even though according to the previous definition qualification should be used.Therefore, in the context of software and computer systems, this primer will also use the term validation.