Re: CVS Certification

[Greg A. Woods]

[ On Wednesday, October 11, 2000 at 16:31:31 (-0500), Olaf Meding wrote: ]
> Subject: CVS Certification
>
> Not sure who I would ask in the case of CVS, but I am looking for a letter
> of ISO/GMP or similar certification  that indicates that CVS undergoes (or
> has undergone) a standard validation procedure.

You'll of course have to do the certification yourself using your own
in-house release of CVS (or contract a qualified engineer to do it for
you) since CVS is not a product that any one person/company could ever
certify, never mind provide third-hand confirmation of ongoing standard
validation procedures!  I.e. you have to internally productize it and
treat it as just another internally manufactured intermediate
component.

> I would also be interested what you/your company has done to certify CVS as
> required by the FDA.

In the one similar case I'm aware of the company I'm thinking of had
their own in-house QA engineers with properly documented verification
and validation procedures which were approved by their auditors.  I
think this was all they had to do to get FDA approval (they were also in
the process of getting ISO 900x approval too).  They were replacing
their home-grown build system (that was centred around imake) with
something far more advanced and which is an integrated part of a more
powerful versioning, release management, and testing system and though I
don't know for sure how everything turned out in the end I do know that
the "vendor" of this system was quite happy with his new client and that
he said they were quite happy with his system.  After all, what could
possibly be worse than imake and bare RCS than nothing at all!  :-)

-- 
                                                        Greg A. Woods

+1 416 218-0098      VE3TCP      <address@hidden>      <robohack!woods>
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