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Reload This Page Validation of Software - NIOSH product (Class II - N95 Respirators)
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7.5.2.1, niosh, software validation, iso 9001 - quality management systems, iso 13485 - medical device qms, occupational health and safety (oh&s), packaging (general), labels and labeling (general)
 
 
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Old 7th January 2010, 09:10 AM
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Please Help! Validation of Software - NIOSH product (Class II - N95 Respirators)
Could someone please explain what type of software this refers to.

We are not 13485 certified but we are doing some outer packaging/labelling and distribution work for one of our own manufacturing plants, of NIOSH product (Class II - N95 Respirators).

I am trying to find gaps in our QMS (9001:2008) and any requirements of 13485 relevant only to the work we are carrying out.

Clause 7.5.2.1 requires the validation of software. What type of software does this refer to. The only software we use in the process is an in house process management system, a prysm labelling system and after completion the product goes into our warehouse management system for stock control/FIFO and shipping management.

Could someone clarify this for me.

Thanks

Cx
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Last edited by ChrissieO; 7th January 2010 at 09:21 AM.
 

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