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Subject:Re: Revision control From:Gene Kim-Eng <techwr -at- genek -dot- com> To:M -dot- Vina-Baltsas -at- mindray -dot- com Date:Wed, 7 Dec 2011 08:42:31 -0800
We put SW version on the cover and on the footer of every page. Users
often print or copy single pages from our manuals to use in the field, and
since there may be units in the field with different SW builds, it's
essential for the user to be able to match instruction to unit build.
The doc revision is less important to us, since our doc revisions roll with
the SW builds. There's a revision block inside the front cover that lists
not only the current rev but all revs of the document and which SW build
each rev is/was for.
It seems to me that you have a 21CFR820 compliance problem if you can't
cross-check your document revisions against their associated device
On Wed, Dec 7, 2011 at 7:52 AM, <M -dot- Vina-Baltsas -at- mindray -dot- com> wrote:
> I write Ops manuals for a medical device manufacturer. We use revision
> control for our manuals but we do not indicate anywhere in the manual
> which version of the software the manual relates to. So, when a client
> calls our Service department or one of our clinical educators and says
> that they need an additional manual, we don't know which manual to send
> them because that history is not maintained anywhere in the manual.
> How do the rest of you manage this?
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