Wayne Pierce
5/3/2005 12:12:00 PM
Take two different programs, with two different languages if you must,
and run both against your program. This way you can compare the
results.
Most auditors just want some assurance that you have thoroughly tested
and documented the environment. By having two different ways to get
the same result you have a check and balance. Whether you want
someone else to write the second check is entirely up to you and your
level of paranoia.
Wayne
On 5/3/05, Simon Crase <simon_crase@bigpond.com> wrote:
> I'm considering using Ruby for a project for a medical application; the
> production code won't be written using Ruby, but I believe that Ruby
> will be a big help for writing test scripts, and also for checking the
> source code to ensure that it conforms to our guidelines, and that
> various tables, in our specification, have been transcribed correctly.
>
> At some point I can imagine an FDA auditor saying:"OK, your Ruby script
> says that the code conforms to your spec. What steps have you taken to
> validate your script?"
> Me "We tested with Ruby Unit"
>
> FDA Auditor "What steps did you take to validate Ruby Unit and the Ruby
> interpreter?"
>
> Any ideas on what to say next?
>
> Cheers,
>
>
> Simon
>
>