Who could give advice on OFF THE SHELF Software Validation, in particular where and how to find official validation on software provided to the public rather than having to reinvent the wheel so to speak?

Thanks for any hints,
Regards, Renate

You mean programs to validate software? What type fo software do you want to validate?

You mean programs to validate software? What type fo software do you want to validate?

Marc,

Haven't been online for quite some time now, but signed on to find your post. The company I'm working for (MED-EL) is one of the three manufacturer worldwide, who manufacturers a medical device, a cochlear implant, and software is developed for the outside processor to the device.

I have only performed manual testing to the software (system testing), but would like to introduce some automation. Being new to the medical field and being new to automation in software testing, I need to know what the FDA accepts and would isn't allowed?

For any hints or comments, I'd be much obliged!
Sincerely, Renate Strina

SQA, Software Testing

Marc,

Haven't been online for quite some time now, but signed on to find your post. The company I'm working for (MED-EL) is one of the three manufacturer worldwide, who manufacturers a medical device, a cochlear implant, and software is developed for the outside processor to the device.

I have only performed manual testing to the software (system testing), but would like to introduce some automation. Being new to the medical field and being new to automation in software testing, I need to know what the FDA accepts and would isn't allowed?

For any hints or comments, I'd be much obliged!
Sincerely, Renate Strina

SQA, Software Testing
www.medel.com (http://www.medel.com)
renate.strina@medel.com This guidance document, General Principles of Software Validation (http://www.fda.gov/cdrh/comp/guidance/938.pdf) from the FDA may answer your questions.

Do a search in the cove there are other threads, like this one (http://elsmar.com/Forums/showthread.php?t=8992&highlight=software+validation), that discuss this topic.