On Thu, Jul 30, 2009 at 05:17, Eric Keller<keller.eric_at_gmail.com> wrote:
>
>
> On Thu, Jul 30, 2009 at 10:39 AM, Bolstridge, Andrew
> <andy.bolstridge_at_intergraph.com> wrote:
>>
>> I found this from Google, it might help you with other aspects:
>>
>> http://linuxmednews.com/1018893577/index_html
>>
>>
>>
>> It appears that the use of OSS is orientated towards software used
>> directly in medical devices, not used to develop that software.
>
> Hi Andrew,
>
> first thank you for your rapid answer and the interesting link you send me.
> As you comment on the news, this has more to do with "off the shelf"
> software being part of the final product.
>
> In our case it would be a "help" software to produce our software product,
> therefore I guess an intern validation of subversion (meaning,
> functionalities like tracking changes, and security like authorization,
> backups, ...) will be the issue.
Do you have to validate all of your infrastructure? Network devices
(Cisco IOS is software, isn't it?)? The OS your developer workstations
run, your IDEs, your mail clients, the software you use to write
requirement documents, etc.?
The fact that you use Subversion should aid in the certification of
your final product (I know my SOX auditors *love* getting
nicely-formatted, consistent changelists), but if Subversion isn't
built into that product, IMHO that shouldn't be a barrier to
certification - if it were, then the FDA would be inspecting every bit
on every hard drive in the company, not to mention the hard drives
themselves.
> Though I don't exactly know what FDA requires about the software process
> validation, during there inspections...
Ask the FDA? Not trying to be difficult, but no matter what we tell
you, the FDA has the last word here.
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Received on 2009-07-30 12:26:43 CEST