Notification[s] for handling Complaing and CAPA handling process in Pharma

SAP QM-QN facilitates work flow process, task monitoring, solution database and FMEA process for handling complaints and CAPA processes. BUT the current fields and reports configuration do not  support specific-requirements of regulatory/organization-.
What are the implications of of customizing the "fields", "work flow" and "reports" inline with the FDA requirements. i.e.,
1. huge number of fields have to added in the notification initiation section which are different for each CAPA process [complaint, deviation, incident]
2. multiple work flow process for each category of CAPA process.
3. multiple reporting requirements for each instance of CAPA record. etc.,
request your comments/guidance on the impact during the life cycle viz., "while upgrading the current versions to next level" etc.,
kindly enlighten.
venugopal.

Hi Venu
MY rek. also same...
Did you get any idea?
If you find please give some detail about How did you design this..
thanks
Sami

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    [/UPDATE]
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    :: Install poppler-glib as optdepend for gimp? [y/N] n
    :: Install hal as optdepend for gimp? [y/N] n
    :: Install alsa-lib as optdepend for gimp? [y/N] n
    Retrieving libwebkit...
    Libwebkit will now be handled exactly as if it were a true dependency of gimp. It is neither explicitly installed nor an orphan. It will get removed with gimp unless it's a depend or optdepend for another package.
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    The Benefits of This Method
    Default pacman behavior remains unchanged.
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    About Metapackages
    A metapackage is a package that contains nothing itself but organizes other packages. For an example of how these work on Arch, take a look at metapax.
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    Here's the discussion on flyspray about groups vs metapackages: http://bugs.archlinux.org/task/8242
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    During a metapackage update, there should be a way to inform the user of new optdepends, but this might be as simple as including an upgrade message in the package install file.
    Last edited by Xyne (2009-01-13 16:20:52)

    No, this wouldn't affect a packages "true" dependencies in any way.
    Packages now have 2 types of dependencies, "depends" and "optdepends". "depends" are installed with the package and are required for the package to run. "optdepends" just display message during installation to the effect of "optional dependencies for this package: foo - for foo support, bar - for bar support, baz - for web access and printing". "gimp" is an example of a package with optional dependencies.
    As it is right now, optional dependencies are nothing more than installation messages. If you decide to install optional dependencies for a given package, they are completely independent of the target package. Let me give a concrete example:
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    Option 2:
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    With option 1, libwebkit clutters my list of explicitly installed packages (pacman -Qet). With option 2, it is considered an orphan by pacman and would be removed with an orphan purge ("pacman -Rsn $(pacman -Qqdt)"). In both cases, if I remove gimp, libwebkit stays on my system even though I only want it for gimp. It will not be removed with "pacman -Rs gimp" because pacman has no idea that it has anything to do with gimp.
    My suggestion therefore it to create a way for pacman to treat selected optdepends as depends. Given the gimp example, what this would mean for the user is that when the user runs "pacman -S gimp", it would present a dialogue as follows:
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    gutenprint: for sophisticated printing only as gimp has built-in cups print support
    libwebkit: for the help browser
    poppler-glib: for pdf support
    hal: for Linux input event controller module
    Would you like to install these optional dependencies? [y/N] y
    Install all optional dependencies? [y/N] n
    Install gutenprint? [y/N] n
    Install libwebkit? [y/N] y
    Install poppler-glib? [y/N] n
    Install hal? [y/N] n
    retrieving libwebkit...
    libwebkit would now be treated as if it had been specified in gimp's depends array. When you uninstall gimp, it would be removed with gimp just as gimp's other dependencies.
    There would also be tools to add optional dependencies to a package later (either with pacman or something else... I'll gladly contribute something to do this), so if you want to add gutenprint to gimp later, you could and then let pacman grab it as a dependency of gimp.
    Again, this has nothing to do with "true" dependencies of packages. This is just a fix for the kludge now known as "optdepends".
    First, let's look at what happens when you install the gnome
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    The idea of a metapackage is that it is an empty package that simply specifies other packages as dependencies (i.e it contains no files, just package information). That's what metapax creates (http://bbs.archlinux.org/viewtopic.php?id=53788). If a gnome metapackage is created with metapax, the user can install it and get all of the packages in gnome. If a new package is added to the gnome metapackage, this package will be retrieved on the next sync update. The user doesn't need to regularly check that he has everything in gnome because the metapackage handles all the packages in gnome.
    The problem with this approach is that everything it specifies is a "depends", so you have to include everything. With "optdepends" though, you would get a similar dialogue to the one when installing a group (as my example above for gimp), but the installed metapackage would have all of the advantages of a package when syncing and uninstalling.
    Users would also create their own metapackages. Lets say that you would like to create a custom DE from existing packages so that you can quickly install a simliar desktop on different systems. You could create a metapackage with your window manager, text editor, image viewer, video player, etc. You could then simply install that package on different machines and be presented with the choice of which components you'd like to install. You could distribute this over your network with a local user repository. If you later want to add another package to it, that package could be optionally included on the different machines during the next update.
    Last edited by Xyne (2009-01-11 18:03:10)

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    Restart job only works the messages which are in error state but not in holding state.. So you have to manually push the message... So there is no other alternative.
    But it should not be that difficult to identify the messages in a sequence..
    How to deal with stuck EOIO messages in the XI ... | SCN
    Though it is for older version, it should be the same.. you should be able to select the additional columns such as sequence ID from the settings..

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