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Author Topic:   Electronic Documentation Systems
Marc Smith
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posted 13 July 2000 01:23 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
From: "Edwin Humphries" edwin@e-quality.com.au
I've watched this thread with considerable interest.
Some responses:

SECURITY
The best way to secure documents over the Intranet is with network facilities: either using your web server's security features, or restricting write access to the directories in which the documents are filed. We try not to use Word documents: HTML and PDF formats are much smaller and create consequently less network traffic. The rule is: if it's only going to be accessed on-line, use HTML; if it's also going to be printed, use PDF.

EDITING
With HTML software so easy to use, it's easiest to convert the files into HTML, and when satisfied, delete the Word files: that way, you only have one version of the file (therefore no version conflicts), and any links you create in the HTML file aren't lost on re-exporting from Word. Don't, for heaven's sake, use Word to edit the HTML files: it's a dog of an HTML editor and produces the worst HTML imaginable. PDF is not an editable format, so any editing must be done in Word, and then the final document exported into Acrobat and bookmarks added, if required.

APPROVALS
The simplest method of ensuring appropriate approval is to discipline the posting process by restricting write access to the directories to those responsible for the document. Then, when the document is altered, if the revised document is online, it can only be because it has been posted (i.e., authorised) by the responsible person). Control is by the logic of the process, not elaborate digital signatures or similar.

Best Regards
Edwin Humphries

------------------------

From: ISO Standards Discussion
Date: Wed, 12 Jul 2000 14:39:50 -0500
Subject: Re: Web Based QMS /../Humphries/Pfrang

From: "Pfrang, Doug" dpfrang@nicoletbiomedical.com

I like Edwin's suggestions, as well as a few others that have been posted, because they address the important issues related to Intranet use without going overboard. Some people have the mistaken idea that Intranet use demands all sorts of extreme procedures for document security, editing and approval. In fact, unless the firm has (or is likely to have) a widespread problem with employees deliberately falsifying documents, the firm should do just fine with a minimal document control system (electronic- or paper-based) that merely prevents accidental tampering.

In other words, the level of document security, editing and approval depend more on the character of the firm and whether it has (or is likely to have) forgery problems than on whether the firm chooses paper or an Intranet as its document storage medium. If the firm has no forgery problems with paper documents, then switching to electronic media should require no significant new procedures for document security, editing and approval.

-- Doug

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Bryan
unregistered
posted 20 July 2000 07:37 PM           Edit/Delete Message   Reply w/Quote
I was reading some of the posts for electronic documentation. I did not see anything that could answer my questions.
I would like to ask 2 questions along this line. We are going to a full electronic system, meaning procedures and work instructions on line with each department responsible for assuring the current copy is posted, (pdf file) at this time. First, does ISO require us to keep a original Hard copy? And second, if a hard copy is not required, is it just a matter of how we define/document how we will do electronic approvals/signatures ? (is this allowed for ISO)
Thanks for any input you can give.

Bryan

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Roger Eastin
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posted 21 July 2000 08:48 AM     Click Here to See the Profile for Roger Eastin   Click Here to Email Roger Eastin     Edit/Delete Message   Reply w/Quote
No, you do not need hard copies (I assume this means paper copies). Electronic signatures are great if you can confirm that the person who's responsible for review/approval are responsible for the signature. For instance, you have an e-mail message stating that the document is reviewed /approved by the responsible person. I'm sure there are other approaches, but something like this works.

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CarolX
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From:Illinois, USA
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posted 21 July 2000 09:55 AM     Click Here to See the Profile for CarolX   Click Here to Email CarolX     Edit/Delete Message   Reply w/Quote
Bryan,

This is what I am doing.

We are going to an electronic system, but I need to maintain approval signatures on file.
I keep a hard copy of the procedure in my "records" file along with a cover sheet listing all the documents released and all the required approval signatures.

Hope that helps a little.

CarolX

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lyman
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From:Salem, Oregon
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posted 21 July 2000 11:10 AM     Click Here to See the Profile for lyman   Click Here to Email lyman     Edit/Delete Message   Reply w/Quote
Bryan:

The company I work for also has an electronic document system including electronic approvals. Our system is set up such that each document has an on-line Index which includes identification of the "Owner" of the document. Our electronic approval document requires that the "Owner" be the first signature sign-off and identifies all the other required signatories by title. When the document(s) hit our Doc Sys Group all they have to do is cross reference the Index to verify that the "Owner" has approved the document revision. The Index eliminates the need for us to keep a separate approval file. Our Level 2 document describes our system and indicates that this is the method we use to ensure compliance with ISO element 4.5.3. So far our Doc Sys Group and the system has been one of the consistent favorites of Third Party and Customer auditors.

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rrramirez
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From:Caracas, Venezuela
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posted 14 October 2000 09:03 AM     Click Here to See the Profile for rrramirez   Click Here to Email rrramirez     Edit/Delete Message   Reply w/Quote
I can convert your quality manual to e-books without the need of Acrobat or any other program.

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Marc Smith
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posted 26 January 2001 02:45 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
Also see https://elsmar.com/ubb/Forum7/HTML/000091.html and https://elsmar.com/ubb/Forum7/HTML/000106.html and https://elsmar.com/ubb/Forum7/HTML/000041.html

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Sam
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posted 26 January 2001 08:55 AM     Click Here to See the Profile for Sam   Click Here to Email Sam     Edit/Delete Message   Reply w/Quote
1- No, you are not required to keep a har copy, however, your registrar may request that you keep one controlled copy; just to give them that warm fuzzy ...

2- Develop a document control procedure for electronic media just as you would for hard copy , no difference.

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Arun Kumar
unregistered
posted 16 March 2001 06:32 AM           Edit/Delete Message   Reply w/Quote
Hi Ali,
In the long run, Laura' suggestion may not work. Please visit us at www.omnex.com. We have some unique solutions for ISO and QS documentation control.

Regards,
Arun

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Don Watt
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From:Notts,United Kingdom
Registered: Mar 2000

posted 16 March 2001 07:10 AM     Click Here to See the Profile for Don Watt   Click Here to Email Don Watt     Edit/Delete Message   Reply w/Quote
Hi,
It's actually Comic Relief (otherwise known as red nose day) here in the UK - raising money for under priveliged children in Africa & the UK.

From the postings today it looks like it may also be "give a plug to Omnex day"!!!!!

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DICKIE
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From:Romulus, MI, USA
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posted 16 March 2001 08:34 AM     Click Here to See the Profile for DICKIE   Click Here to Email DICKIE     Edit/Delete Message   Reply w/Quote
Don, I was waiting for someone to make the OMNEX crack. congrats.

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Laura M
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From:Rochester, NY US
Registered: Aug 1999

posted 16 March 2001 03:07 PM     Click Here to See the Profile for Laura M   Click Here to Email Laura M     Edit/Delete Message   Reply w/Quote
Arun,
I have yet to post in this thread, so I'm curious as to what suggestion I had that won't work in the long run. If you mean the document control idea, then maybe you can explain why - cuz in the short run it is working just fine.

Laura

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Jim Triller
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Posts: 26
From:Seattle, WA USA
Registered: Oct 2000

posted 16 March 2001 06:47 PM     Click Here to See the Profile for Jim Triller   Click Here to Email Jim Triller     Edit/Delete Message   Reply w/Quote
I've designed and implemented web-based ISO 9001/2 registered systems for five companies, some of which have multiple, remote locations and have been registered for five years. All of the webs use HTML and scripts as well as "server side permissions." I have yet to have ANY findings or issues related to this approach (and only well known, reputable registrars were used). Additionally, this method requires no additional (proprietary) software or "seats." I would be very interested to hear about any negative issues that may result "over the long term" from taking this cost effective, efficient approach to documentation management and distribution.

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