In Reply to Parent Post by cbearden
Ok.....I'm the end user of a Coordinate Measuring Machine Software (PCDMIS by Brown and Sharp).......My question is about Software/Process validation.
In my mind, I just want to know that the Software is giving me the true results from my measurements........Plus, I want to keep it Simple (K.I.S.S)
So, here is what I want to do.......Take several known standards (Class 1 GageBlocks) and measure them. If the Software tells me that a 1" gageblock checks 1.000005", then I know its giving me correct results.......Software VALIDATED!!!!!!...........
Do you think this would be acceptable to an auditor?
The answer to this question is based on what standard or requirement the auditor is inspecting to. If it is for Medical Devices then its ISO 13485 section 7.6 refers to ISO 10012, Measurement Management Systems. I recommend you read this if you are in the Medical Device Manufacturing business. This standard is helpful in understanding what is necessary for ensuring your systems are adequate for their intended use and what is expected in the industry. Note this is only a standard, FDA has very specific requirements for Software Validation under:
(i) Automated processes. When computers or automated data processing
systems are used as part of production or the quality system, the manufacturer
shall validate computer software for its intended use according to an established protocol. All software
changes shall be validated before approval and issuance.
and Guidance on Principles of Software Validation.
In my 20 years of experience working with FDA and ISO auditors and various major pharma and device companies , I have yet to see an internally validated CMM apparatus.
Zeiss will provide you a certificate of validation that the Calypso software is developed and tested for the instrument and this may be sufficient, but this depends on your company's products and level of risk, and intended use of the equipment in the process.
If you see an example or have other information please post on this forum trail.