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Subject:Re: Revision control From:M -dot- Vina-Baltsas -at- mindray -dot- com To:Gene Kim-Eng <techwr -at- genek -dot- com> Date:Wed, 7 Dec 2011 11:52:14 -0500
Gene,
I don't know anything about 21CFR820 compliance (other than what the
internet has) but will mention this as a possible issue at my meeting this
afternoon.
Tel: 201-995-8350
m -dot- vina-baltsas -at- mindray -dot- com
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From:
Gene Kim-Eng <techwr -at- genek -dot- com>
To:
M -dot- Vina-Baltsas -at- mindray -dot- com
Cc:
techwr-l -at- lists -dot- techwr-l -dot- com
Date:
12/07/2011 11:42 AM
Subject:
Re: Revision control
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
versions.
Gene Kim-Eng
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.
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