Re: Document Control/Quality Management

Subject: Re: Document Control/Quality Management
From: "Barry Campbell" <barry -dot- campbell -at- gmail -dot- com>
To: Amanda <amanda -dot- barrientos -at- comcast -dot- net>
Date: Mon, 20 Nov 2006 07:10:36 -0500

On 11/19/06, Amanda <amanda -dot- barrientos -at- comcast -dot- net> wrote:

I was recently charged with the task of locating "something that will help
us do this" - referring to software for the control of documents in an
ISO/FDA/CE regulated environment. I know the basics of what he wants/what
we need.but I KNOW there are things I'm missing. Help. What questions should
I be asking? Advice? Suggestions?

The first question I would ask, and I'd want the answer to be official
and in writing:

Which SPECIFIC regulations or standards for document control are we
required to comply with now, and what is our best guess about what we
will be required to comply with in the foreseeable future? (If your
firm operates in a regulated environment, there's almost certainly
someone designated as the compliance officer; ask this person.)

Develop your requirements list based on this information, and use that
list as your basis for evaluation of methods, processes and products
to meet your document control needs. Make sure that your compliance
officer and your management signs off on your requirements list and
keep them in the loop every step of the way as you do your research.

Let's assume that your firm develops software, for instance. Maybe
"ISO" means some or all of the following: ISO 9000/9001 quality
standards. Or ISO/IEC 12207 for software development lifecycles?
ISO/IEC 15288 for systems engineering documentation? ISO/IEC 15910
for user documentation? Etc.

Or, since you mention FDA regulations, you're almost certainly
required to comply with 21 CFR Part 11, and probably others. (Does
your firm make medical devices? See ISO 13485:2003...)

- bc, doesn't work in highly regulated environments much lately but
remembers it well

Barry Campbell -- <barry -at- campbell-online -dot- com>

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Document Control/Quality Management: From: Amanda

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