Starrett AV612 (combo vision and touch probe) Galileo Instrument Software Validation

R

RoscoeSplevins

#1
Management and customers are insisting on validation of our Starrett AV612 (combo vision and touch probe). The function is heavily computer program driven, thus we must validate the software, hardware, and data manipulation. I feel confident in setting up the OQ / PQ for the stage and data calculations. BUT how does one go about validating the background software? This is medical related so we must conform the FDA and ISO 13485, and current customer practice.

Thanks in advance.
 
Elsmar Forum Sponsor

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
Re: Starrett AV612 (combo vision and touch probe) Galileo Instrument Software Validat

Can any CMM experts help with this one? My Thanks in advance!
 

Mortalis

Involved In Discussions
#3
Re: Starrett AV612 (combo vision and touch probe) Galileo Instrument Software Validat

I know this is an older thread and may not be relevant any longer to the original poster but I thought I would put my 2cents worth for anyone that may have the same question.

I started working for a medical components manufacturer and they validate the part program on their VMM's by measuring 6 pcs 5 times on the VMM and collecting that data and then they take those 6 pcs and with have an inspector that is unbiased to the previous measurements measure the parts on a different piece of equipment and then run correlation between the two pieces of equipment. They then will place the program file for each part on a secure server that is read only so it cannot be altered and saved. They have developed a documented procedure that describes this process.

Hope this helps
 
L

LulaNord

#4
Re: Starrett AV612 (combo vision and touch probe) Galileo Instrument Software Validat

Hi...i am a new user here. In my case i had a medical components manufacturer and they validate the part program on their VMM's by measuring 6 pcs 5 times on the VMM and collecting that data and then they take those 6 pcs and with have an inspector that is unbiased to the previous measurements measure the parts on a different piece of equipment and then run correlation between the two pieces of equipment.
 

Similar threads

Top Bottom