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Sara-Sue...this lab...do they fall under the FDA in any way, shape,
or form? If they do, they need to comply with the rules and
regulations outlined in the Code of Federal Regulations, Part 21.
See the following links:
I'd look closest at number #58, #820, and if any of the rules apply,
then you need to look at #11
Ask them if they have any interaction with the FDA. The bad news (for
them) is that this is NOT a minor undertaking. The good news (for
you) is that you'd have more work than you can handle in 10
lifetimes.
> I'm just wondering if anyone on the list has had experience with
> writing laboratory analytical procedures? These procedures
> describe how to perform certain kinds of laboratory tests for
> wastewater and/or for drinking water quality.
-
> I'm working on a contract. This lab had a set of existing standard
> operating procedures for these test methods. The client is going
> for ISO 17025 lab certification. They directed me to transfer the
> content of the existing procedures into their new ISO template.
> Their existing documentation was fairly poorly written- some
> things listed as steps that weren't actual steps mixed in with
> with notes, cautions, incomplete sentences etc.
-
> It seems that they were (or may still be) laboring under the
> impression that *all* they had to "do" was transfer this content
> and presto they'd be done.
-
> There are approximately 40 procedures in total. (s far as I know,
> this is their first "large" documentation project and they've never
> had a technical writer before.)
=====
John Posada, Senior Technical Writer
...and everything...is...42
--- Deep Thought
-----------------------------------------------
"Will work for money"
Resume: http://www.tdandw.com/Resume_Posada_050502.doc mailto:john -at- tdandw -dot- com, 732-259-2874
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