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- W1593598010 abstract "Results generated using analytical procedures provide the basis for key decisions regarding compliance with regulatory, compendial, and manufacturing limits. A high degree of confidence is needed that the analytical procedure will generate reportable results that meet requirements under all conditions of use as the procedure progresses through the life cycle. A state of control is established for instruments by calibration and qualification activities and for software applications, by validation. To assure laboratory data integrity, qualified instruments, validated systems, and procedures are critical factors to control. This chapter considers requirements and approaches to achieve a state of control for instruments and systems to underpin validated analytical procedures. Analytical procedures in pharmaceutical analysis are subject to highly formalized validation procedures in order to demonstrate that they are suitable for the intended use." @default.
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- W1593598010 date "2014-08-15" @default.
- W1593598010 modified "2023-10-17" @default.
- W1593598010 title "Analytical Instrument Qualification" @default.
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- W1593598010 doi "https://doi.org/10.1002/9783527672202.ch2" @default.
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