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I would question your Quality / Regulatory department to see if numbered paragraphs are truly a regulatory requirement, or if they are simply something someone implemented a long time ago as a way to refer to individual paragraphs easily (but isn't actually a true regulatory requirement).
I work for a medical device company. We submit documentation to FDA for approval all the time. I just finished developing company templates.
We do not use any numbered paragraphs.
Our technical manuals use numbered headings.
Our operator manuals do not use numbered headings.
FDA seems fine with what we are doing...
From: techwr-l-bounces+bdavies=imris -dot- com -at- lists -dot- techwr-l -dot- com [mailto:techwr-l-bounces+bdavies=imris -dot- com -at- lists -dot- techwr-l -dot- com] On Behalf Of Becca
Sent: October-16-12 11:03 AM
Subject: Numbering paragraphs
At my current job, in the documents we create, all paragraphs are numbered. I think this is a regulatory issue - we develop medical devices, and everything is under strict FDA rules.
I'm currently creating templates and developing procedures for writing procedures. I've never worked in this kind of environment before, so I'm trying to develop guidelines for when things need to be numbered, and when a simple bullet list will do, for example.
What I currently have is the following:
1.1 Numbering Paragraphs
1.1.1. Number paragraphs and sub paragraphs.
1.1.2. If a list under a numbered paragraph is to be considered part of that paragraph, use bullets. If the list under a numbered paragraph consists of items that can stand alone, number the paragraph as a sub-number to the original paragraph, See section 5.3.1 of this document for an example of when to number a list. See section 188.8.131.52 of this document for an example of when to use bullets.
Does this sound reasonable? or should what would ordinarily be a bullet point be numbered with the next sub-level of heading?
As another example, if I'm listing the items that should be in the document header, should those items be bullets or numbered?
Thanks for any guidance you can give me.
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