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Risk analysis

 
     
 

Risk analysis is an integral part of the qualification process for assembly systems. It enables actual and potential product and system risks to be identified and minimized.

sortimat performs this assessment on the basis of Failure Modes and Effects Analysis (FMEA), and in accordance with GAMP 5 guidelines. Each potential and actual risk is evaluated according to how it will effect, for example, the end user, the physician, the machine operator and cost efficiency. We also consider how risks can be controlled and minimized, and after any action is taken, perform a re-evaluation.

 

Risk analysis
 
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Risk analysis
 
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