How do we handle Lab Instruments?

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The instrument and its IT system need to be validated. The approach is the same as described under Validation/qualification. What needs to be done depends totally on what the instrument is and its complexity. Another factor is whether the system is able to run barefoot (without the computer system) or if the computer system is integrated in such a way that it is needed in order to use the instrument. Obviously there is a lot less to do with a pH meter or a balance than a GC-MS.

If we look at a chromatograph, this has several parts, which each needs to be qualified. This is done by identifying the parts and their functions, and setting up test plans which will show if the parts work correctly.
• The sample holder
• The injector
• The pump
• The detector
• The column
• The column oven