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It would be usual for engineers at the client company to author the FAT and SAT documents.
For FAT in particular, input from the supplier may be highly useful and relevant. If the FAT work is to be used in a subsequent validation (so as to avoid repeating tests etc) then it should additionally be approved by the functions who would normally approve the validation documents where the repeat tests would be (if they were being done). If the FAT document is to be used in validation, then it is also important to remember that acceptance criteria must be used - so as to state in advance what result means the test has passed or failed. If correctly approved, FAT documents can avoid a lot of repetition in IQ and OQ. If the test would be performed exactly the same at the suppliers' site (FAT) and on the client site (IQ or OQ), and there are no changes between the performing of the FAT, and the test result could not change (eg due to dismantling, shipping, re-installation etc), then it would not need doing again. SAT can be used in exactly the same way as above - with the same points in mind. Cat |
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| fat, sat |
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