Monitoring and Measurement / Environmental Controls
I was hoping that you could clarify something for me that I am struggling to find information on.
We have been completed 200 surface samples, all but 1 have been within our established criteria. If I select critical areas, can I only test those specific areas ?
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Yes, you can reduce the number of sampling sites. It is recommended that you perform validation of that process, where you will analyze all data that you have collected so far and explain why is it justified to reduce the number of sampling sites.
For more information, please see the following link:
- Using ISO 13485 to manage process validation in the medical device manufacturing industry https://advisera.com/13485academy/blog/2017/09/07/using-iso-13485-to-manage-process-validation-in-the-medical-device-manufacturing-industry/
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Mar 05, 2021