as of 2017 – 10 - 13

14.D Laboratory Instruments

14.D Laboratory Instruments
Here you will find answers to the following questions:

What instruments have to be qualified?

How is the qualification carried out?

What qualification documentation has to be created?

What scope of qualification is both useful and necessary?

How is instrument software validated?

What has to be done when the configuration of an instrument is changed?

How are instruments managed?

Which instruments have to be calibrated?

How and how often is calibration carried out?

What needs to be done if calibration is not successful?

How is calibration documented?

What level of maintenance is required for laboratory instruments?

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