How can I accomplish my idea?

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How can I accomplish my idea?

Postby javydreamercsw » Thu Jun 26, 2008 5:50 am

Hi community!

My name's Javier Ortiz, Java programmer for 5+ years, and still learning, with a project I've been building in my head for quite a while. I've been in FDA regulated environments as Software Quality Engineer finding myself more than often drowning in validation paperwork.

My solution to all the troubles there? A software to write, approve, execute and post approve validation protocols and related documentation. I'm head programmer of an open source DMS (Document Management System) that I won't name 'cause I'm not sure if I'm allowed to.

Here's my plan:
1.Login to a system (possibly a web application in a server) with roles and stuff
2.Using Writer, write a protocol as a normal document (author role).
3.Saving in authoring state is allowed to be off line (not in the web app)
4.Define fields or areas of protocol for data entry (forms?)
5.Ability to have range of values in those fields (max - min for dates, times, integers; Pass/fail, etc)
6.Getting out of valid values/Fail generate exception (to be handled possibly by web application)
7.Once the document is complete set it to a review state (basically track changes) from which the document can't be changed (only author can to incorporate changes)
8.Saving in review state is only possible on line.
9.After approved the doc goes to the execution stage (again basically track changes for protocol red lines possible during protocol execution) and the exception handling noted in step 5.
10.Each result/red line is timestamped and signed (electronic signature). This stamp can't be removed in any way. (is this possible? I guess this should be on line as well)
11.Validator/Reviewer/Approver is allowed to add comments to the document (as footer comments)
12.When execution completes the operator/validator sends it for review (another stage like the review step).
13.Approved state, nothing else can be done to it, besides using it to generate a new version from the red lines for example.



States have the following characteristics:
1.The author can't be validator.
2.Validator can't review his own work.
3.More than one validator can execute different parts of the protocol so a way to lock protocol sections should be available (using section properties maybe?)
4.Reviewer can't be validator.
5.Approvers can't be validator.

Where's that's a brief summary. I have no problems handling the web application side but have 0 knowledge on the Writer part.

I'll be working on the developer's document but any guide on what objects to use/approaches is more than welcomed!

Thanks in advance!
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Re: How can I accomplish my idea?

Postby Villeroy » Thu Jun 26, 2008 12:36 pm

This has nothing to do with OpenOffice.org. Use XML and write a simple XSLT-filter to generate your reports in ODF, PDF, LaTeX, HTML, or whatever is currently needed. A text processor is about freestyle editing, offering hundreds of editing features in a GUI. Sometimes it may be useful to generate such complex formats for editing. However, your content managment system should not rely on a particular office suite. This would contradict the founding idea of ODF and OOo.
Please, edit this topic's initial post and add "[Solved]" to the subject line if your problem has been solved.
Ubuntu 18.04, no OpenOffice, LibreOffice 6.x
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Re: How can I accomplish my idea?

Postby javydreamercsw » Thu Jun 26, 2008 1:22 pm

I think that either I didn't explained myself or you misunderstood me.

I think this has to do with OpenOffice.org since it is the tool I'd like for generating and controlling the document thru the various stages. The DMS will be used for storing the files etc. and will not be dependant on OO in any way.

Thanks for the comment anyways.
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