Add-on for Quality

Hi
One of my client is implementing 21 CFR Part 820 and ISO 13485 QS standards in US. Please let me know if there are any add-ons available that will help facilitate implementation and provide management tools for both of these standards or the FDA 21 CFR Part 820 as a minimum.
Regards
Louis

Louis,
For these 2 Quality standards I do not think there is any specific AddOn.  But I would say that to comply with these standards what ever is needed from the system mainly on the reporting side can be facilitated by configuration and through custom reports.
The ISO organization mainly validates standard on reporting and document maintenance and since I was involved on a few projects governed by ISO, I can say it is very much doable.
Any thing related to FDA mainly looks at tracability of an Item and how soon a Recall can me made on case of any quality issues.
When you have a Serial or Batch Managed Item, the Item can be easily traced to meet FDA's requirements.
Best wishes
Suda

Similar Messages

  • ADD On of Quality Management

    whr i can find Add on on Quality Management
    Quality Management
    Quality Planning       Need Addon
    Quality Notification          ""
    Quality Inspection (Raw materials in Procurement and Finished products in Production)   "",
    Test Equipment Management

    Hi,
       For Test Equipment Management here is the link for SAP library:
    http://help.sap.com/saphelp_nw04/helpdata/en/2d/352209448c11d189420000e829fbbd/frameset.htm
    For quality notification.
    http://help.sap.com/saphelp_nw04/helpdata/en/8d/3e6143462a11d189000000e8323d3a/frameset.htm
    Hoping this might help you in your query.
    Have a best day ahead.

  • Adding a comment field in block for quality reasons subscreen of XK05?

    Hi Experts,
    I have requirement to add a comment field in block for quality reasons subscreen.
    I didn't find any BADI for this requirement.
    Kindly any one advise is it possible to add this comment field in XK05.
    Regards,
    Anusha

    Hi Raymond,
    Thank you for the reply. As per the note some one already implemented the Screen Enhancement with 2 custom views. I need to add the field in any one of existing custom view. So for this I have created a Subscreen in copied function group of MGD1(Y_FE_MARA). But in the function group already 10 Subscreens were created. Is this is the problem? or else copy the FG MGD1 into another FG and create the subscreen will be feasible to my scenario?
    Please suggest me.
    Thanks and Regards,
    Muralikrishna Peravali

  • Automatic batch determination for quality inspection stock

    Hello, gurus.
    Could you please, help me with the following problem: I have received on the certain storage location some quantity of material maintained in batches into quality inspection stock with 501 movement type. Now I would like to make reverse posting, but I do not want to use cancellation of the document, I need to use 502 movement type and determine batch from quality inspection stock with automatic batch determination in MIGO transaction. I assigned Batch search procedure to 502 movement type and created all necessary condition records. I use Checking Group for Availability Check ‘CH’ and Checking Rule for Availability Check ‘03’ where I include quality inspection stock. However no batch can be determined. But if I use 331 movement type, everything is OK, the batch is determined without any problems. If I manually put batch and valuation type for the material, the system shows no error.
    Why it is not possible to do automatic batch determination for quality inspection stock then?

    OK, let us talk abou it. I check it in my system, actually 502 can work, but I can't trigger BM determination by 501. Maybe BM determination onlys to select some existing batches for consumption. For 501 in my pratice I can select all the existing batches to be added or just add a new batch.

  • Manufacturing Add-on for SAP B1

    Hi All,
    Manufacturing add-on, designed for SAP Business One, for its pioneering ERP solutions for the Process Manufacturing Industry where formulas or recipes drive the production process rather than a Bill of Materials (BOM ).
    Manufacturing designed to have following modules
    Core Modules:
    ü        Formulation
    ü        Bill of Materials
    ü        Costing
    ü        Laboratory
    ü        Production
    ü        Quality Control
    ü        Unit of Measure
                Optional Add-on Modules:
    Ø         MSDS and SARA Reporting
    Ø        Compliance Reporting (FDA, HACCP & Bio Terrorism Act)
    Ø         MRP and MPS
    The customers will obtain immediate benefits as BMM seamlessly integrated to have
    ü       SINGLE SAP Business One Database
    ü       SINGLE SAP Business One Login
    ü       SINGLE Menu u2013 all screens run from SAP Business One menu
    ü       Drill-down & Hyper-links between Manufacturing & SAP Business One
    ü       SAP Business One SDK used for database updates
    ü       Customized fields on SAP Business One screens
    In case of any queries, please feel free to contact.
    Thanks
    Shrikant
    Thanks

    Hi Shrikant -
    I am also looking for a Production Add on for a new customer. My Email Address is [email protected] and you please provide me some details on what your add-on does.
    Thanks
    Manoj

  • Reporting Services Add-in for Sharepoint- does it need an SQL Server license?

    In a new project we will be creating an SSRS in Sharepoint integrated mode. For this we'll need SQL Server and Sharepoint on that box.
    We'll also have one or more SharePoint Web Front End (WFE) servers. To allow them to connect to the SSRS-in-sharepoint-mode box, and to present the user with the right user interface for doing so, I believe we can install the Reporting Services Add-In for
    Sharepoint on the WFE servers.
    The question is, do we need to have  SQL Server license for each WFE server where we use the Reporting Services Add-In, or is it free to use?
    We've had advice that we need to buy a SQL Server license everywhere we use the add-in, but I am not sure this is correct.
    Thanks in advance,
    Rich

    Hello there,
    The Reporting service Add-in for SharePoint can be downloaded free on Microsoft Download site. That means it does not need any license on the add-in.
    Regards,
    Edward
    Edward Zhu
    TechNet Community Support

  • What is the difference between: "Place..." or "Add files for Upload..."?

    Where can I get information about the detailed differences between the commands "Place..." and "Add Files for Upload..." of the Files menu?
    Understand that in both cases the files are linked and not embedded. But what further differences are there?
    I came across this issue because widget 039 (Animated Image Rollovers) from MuseThemes works only if you use the "Add Files for Upload..." option.
    Thanks,
    Daniel

    Hi Daniel,
    There are a few differences in both the options-
    Place is used to add content to page (rendered) while Add Files for Upload... is used to upload files to your site but not on page (not rendered).
    Placed images are published to /images folder on the server while images added using Add Files for Upload... option are published to the /assets folder on the server.
    Placed images have a chance of getting renamed (if resized/interpolated in Muse) upon publish while images added using Add Files for Upload... retain their names.
    Place can be used to add limited file formats like jpg/png/psd/swf/oam etc while you can upload almost any type of file using Add Files for Upload...
    You don't see Placed content in the Hyperlinks dropdown for linking while files added using Add Files for Upload... show up in the Hyperlinks dropdown so that you may link to them and allow download.
    Both serve different purposes and Add Files for Upload... is preferred by Widget Developers because it gives more control over uploaded content and assurance that file location and name will be as expected.
    Hope the above give you clarity on the basic difference.
    Cheers,
    Vikas

  • Frustrating time to find the Solution Manager add-on for CPS Scheduling.

    I have spent a couple hours looking through my maintenance optimizer and the software download site. 
    The problem is that I cannot seem to find the plug in anywhere.  I have found posts pointing to different locations but each one has been a dry hole for me.
    So here are the questions
    1) Does the SolMan Add on for CPS scheduling cost ? I believe it is ST_PSM
    2) Where is it on the download site?
    Thanks
    George

    ST_PSM is not part of the "normal" Solution Manager license, it must be licensed separately. If you don't have that license you won't see the it in the Download Center.
    Check
    Note 1109650 - SAP Solution Manager 7.0 Extension Addon's (which contains the correct paths in Download center)
    Note 1122497 - Process scheduling for SAP Solution Manager
    Markus

  • I am trying to get the CLIPPINGS add on for firefox. but it says it is not compatible with FirFox 8.0 whaat can I do.

    I am trying to get the CLIPPINGS add on for firefox. but when I try and download it, it says it is not compatible with FirFox 8.0. also the latest version of firfox is 3.1 but my version is 8.0 Is that right?

    There were some issues with the addons site and checking for (compatibility) updates.<br />
    It seems to be working now, so you can try again to install the extension.

  • Recieveing "OnUCAppointmentGetVisible" error in Outlook 2013 (64 bit) - "Custom UI Runtime Error in Lync Meeting Add-in for Microsoft Office 2013"

    Hi All,
    I originally posted this in the MS Support forums (http://answers.microsoft.com/en-us/office/forum/office_2013_release-outlook/recieveing-onucappointmentgetvisible-error-in/1a40eca2-8cd1-40f1-a92f-cb08f0af6b72), but was directed over here.
    I have recently upgraded an installation of Office 2010 to 2013 (both 64 bit) but am now receiving an error which says:
    Window Title - "Custom UI Runtime Error in Lync Meeting Add-in for Microsoft Office 2013"
    An error occured while calling the callback: "OnUCAppointmentGetVisible"
    This seem to happen when I initially open a calender entry, and when I close the entry (most only the first time I close the entry).
    I did have some developer tools installed for Office 2010 and VS 2010 which played around with Excel,2013 but I have now uninstalled these.
    In addition, BCM 2010 was installed (but for the time being has been uninstalled), but I don't think that is the culprit.
    The issue is being caused be an Outlook add-in. I have three COM add-in enabled, but the one causing the issue in the "Lync Meeting Add-in for Microsoft Office 2013".
    We are currently trialling Lync in a demo installation which is in a different domain to any of the Exchange accounts, but should this cause a problem? For the time being I have disable this add-in.
    Regards,
    Chris
    Chris

    Hi,
    Sorry for my misunderstanding. If the issue is determined to be caused by Lync Meeting Add-in, please remove this add-in from Outlook, then go to Control Panel to repair Office 2013 program. After repairing,
     this add-in would be automatically reinstalled. Please check whether the issue persists. About how to repair Office programs, please refer to:
    http://office.microsoft.com/en-us/outlook-help/repair-office-programs-HA010357402.aspx
    If the Lync Meeting Add-in is not automatically reinstalled, please try to manually add this add-in by the following steps:
    1. Starting Outlook 2013 as an Administrator (right click, run as Admin).
    2. Click File > Options > Add-ins, Manage Com Add-Ins Go... > Add..., C:\Program Files (x86)\Microsoft Office\Office15\UCAddin.dll, OK.
    3. Close Outlook and start it as a normal user.
    Regards,
    Winnie Liang
    TechNet Community Support

  • Any hope for quality basic phones?

    I'm out of contract, just got done browsing for a basic replacement phone and am disappointed with the current offerings. I feel that was marketing and intended. I've been a Verizon Wireless customer since 2001 and I was grandfathered in once they bought Alltel. I like to use Verizon because I get good reception in my area on their voice network and many of my family and friends use the service, so we have free mobile-to-mobile calls and texts. I say free, but I consider it a bargaining chip that came as part of the fee in the plan that I pay for every month.
    I do not want a "smart phone" my lifestyle doesn't need or desire it. I have computers at work and home and all my typical haunts, I don't want to carry around an additional Internet device in my pocket (yes I know basic phones can access the net too in a limited way, for a premium). Being constantly online isn't desirable to me. I don't want to be GPS tracked, or browse the Internet on a tiny little phone screen. I like my old voice and text plan, the price is right. I'm not inclined to pay at least an extra $30/month to start a service that I don't want and just open the door for data overage fees - Just to have a decent phone! It's a despicable and ethically embarrassing corporate strategy.
    So without getting into the profit motivations for phasing out basic service plans by only offering smartphones, why can't we have:
    Long battery life
    modern tablet style ergonomics
    decent reliable OS
    possible wi-fi if desired
    Good camera and flash
    rugged enough to last at least the duration of a 2-year contract with normal wear
    Good sound quality and antenna
    Technologically we already nailed it, have been there a long time but instead you try to force us to commit to these expensive bells and whistles many of us don't need or request. In this day and age I feel that basic phone service is a need, so why not do it right and excel at it? You probably don't make as much money off of it, but I'm still happy to pay like I have been if you would just sell a reasonable device for me to use. I'm tired of being made to feel like a second class citizen in the Verizon store with my old flip phone because I just want options, and my requests are fundamental, only basic service and good performance with my phone.

    That tired old argument?
    I don't buy this supply side excuse. All these phones are useless without a service provider. Most are locked to providers. The manufacturers sell what the buyers want and the real buyers are the carriers, who then resell to the consumer.  The carriers want to pay the leases on their new networks and maximize profits, so they need data plans. Many consumers want these features and many do not (jaymeson). My gripe is with the quality of Verizon's non-data plan phones sliding backwards...
    In my business, satisfied repeat customers are the majority of clients. Did Verizon not make profit before the smartphone hype? Verizon is diversified and very large, they tend to trample the individual consumer and it's their way or the highway. I had an experience in what was called a "corporate" verizon store yesterday. I wanted to evaluate my plan and make sure they had count my promotional minutes. The new alert system I learned is based off only your plan minutes and so before knowing that I got nervous when texts came in that said that I was reaching my allotment early. I thought they dropped my promo. I went into the store to sort this out face-to-face. It was quiet, there were three salesmen standing in the corner twisting their thumbs and doing nothing while I waited half an hour to be seen by someone. After authenticating me with my account, supposedly they couldn't pull my plan up on their computer and rudely kept pounding the mantra that I had to call customer service! Total waste of my time.
    I've ended up ditching Verizon and ordering a nice new out-of-contract smartphone (best bang for buck feature-wise) and it should be here in a couple days. I'm activating on a different network, not as expensive or fast, but I don't need the download speed perks and will block most of it. The prepaid as suggested by Weth provides the freedom that I want. I'm only remaining on Verizon until I get the new phone in to activate and port over my number. If I like it the business contract phones will follow.
    I'm going to consider this thread closed. I learned there is NO hope for quality basic phones on verizon. Thanks for participating.

  • Error while installing the SAP J2EE add-on for SAP NW XI installation

    Error while installing the SAP J2EE add-on for SAP NW XI installation  
    Posted: Jan 24, 2007 5:23 PM         Reply      E-mail this post 
    Hello,
    When I am installing the SAP SAP J2EE add-on for SAP NW XI installation I am getting the follwing error:
    CJS-00084 SQL statement or script failed. DIAGNOSIS: Error message: Executable /oracle/XID/920_64/bin/sqlplus returns 127.. SOLUTION: See ora_sql_results.log and the Oracle documentation for details
    Could some one help me to resolve this error and install the SAP J2EE add-on?
    Thanks,
    George

    Hi George,
    Kindly use the latest installation Masted in Service market place. That will possibly solve your problem.
    Regards
    Vivek

  • Error while Installing the Java Add-In for an Existing ABAP System

    Hi all,
    I need help, i am Installing the Java Add-In for an Existing ABAP System
    SAPInst stops on the first installation step: "Central Services Instance (SCS) Java Add-In", the step is "Install common system files" on the following sub-steps:
    These are the last few lines on the sapinst.log.
    INFO 2009-05-21 12:35:12
    Execute step createAccounts of component |NW_Addin_SCS|ind|ind|ind|ind|0|0|NW_Users_Create_Do|ind|ind|ind|ind|3|0.
    INFO 2009-05-21 12:35:18
    Execute step setUserEnvironment of component |NW_Addin_SCS|ind|ind|ind|ind|0|0|NW_Users_Create_Do|ind|ind|ind|ind|3|0.
    INFO 2009-05-21 12:35:19
    Execute step InstallJDBCDriver of component |NW_Addin_SCS|ind|ind|ind|ind|0|0|NW_JDBCDriver_DB4|ind|ind|ind|ind|4|0.
    INFO 2009-05-21 12:35:19
    Creating directory V:\sapmnt\BIQ\jdbc.
    INFO 2009-05-21 12:35:19
    Creating directory V:\sapmnt\BIQ\jdbc\tbx.
    INFO 2009-05-21 12:35:21
    Copied file 'V:/QIBM/ProdData/HTTP/Public/jt400/lib/jt400.jar' to 'V:/sapmnt/BIQ/jdbc/tbx/jt400.jar'.
    INFO 2009-05-21 12:35:22
    Execute step updateNtPatchDlls of component |NW_Addin_SCS|ind|ind|ind|ind|0|0|NW_System|ind|ind|ind|ind|5|0.
    INFO 2009-05-21 12:35:23
    Execute step sCreateSystemOS4 of component |NW_Addin_SCS|ind|ind|ind|ind|0|0|NW_System|ind|ind|ind|ind|5|0.
    ERROR 2009-05-21 12:35:42
    MOS-02001  Call of command "CRTR3SYS SID(BIQ) GLOBALHOST(*LOCAL)" failed. Exception is "CPF0006".
    ERROR 2009-05-21 12:35:42
    MOS-02001  Call of command "CRTR3SYS SID(BIQ) GLOBALHOST(*LOCAL)" failed. Exception is "CPF0006".
    ERROR 2009-05-21 12:35:42
    FCO-00011  The step sCreateSystemOS4 with step key |NW_Addin_SCS|ind|ind|ind|ind|0|0|NW_System|ind|ind|ind|ind|5|0|sCreateSystemOS4 was executed with status ERROR .
    Thanks in advance for any help.
    Kiran Chebrolu

    Hi,
    Hope this note would solve your issue, please read carefully and validate with your issue
    Note 1032019 - Java Add-In: Error when you create the SCS instance
    below notes give your suffice information.
    Note 883948 - NW 7.00(2004s): Inst.Add.Java Usage Types/Software Units
    Note 1268493 - NW 7.01/BS 7: Inst.Add.Java Usage Types/Software Units
    Note 1025789 - RUNR3CMD generates CPF0006
    regards
    nag

  • Error: installing Java Add-in for Central instance

    Dear experts,
    i've installed the SCS and the Java Add-in for DB successful. While trying to install the java add-in for the central instance i get the following error:
    An error occurred while processing service SAP NetWeaver 7.0 Support Release 3 > Software Life-Cycle Options > Java Add-In for ABAP > MaxDB > Central System > Central Instance Java Add-In ( Last error reported by the step :TypeError: instance has no properties (in script NW_Addin_CI|ind|ind|ind|ind, line 109346: ???)
    Thanks in advance.
    Daniel

    Hi,
    Check below thread:
    Error installing SAP NetWeaver 2004s Java Trial Version (SP9)
    Thanks
    Sunny

  • Add on for SAP 2005 B one run in the SAP 2005 A

    Hi to all,
             I have one Doubt.the add on for sap b1 2005 B shall we run in the sap b1 2005A.      
            If Anybody know reply quickly please !!!
    Regards,
    Ramya.S

    Ramya,
    It will depend on which Addon's you are referring.  Certain Addon only apply to certain localizations while others are common to both A and B.
    Example: Outlook integration would work for both A and B, while the Fixed Asset add-on might not be applicable to all localization within A or B.  It all depends.
    Suda

Maybe you are looking for

  • Another "I can't empty my trash!" problem...!

    Hi All, Sorry, but this is another "I can't empty my trash" problem. Have scoured the internet trying all the remedies but can't seem to delete these stupid folders. I've tried the option key, secure emptying, going into Terminal, Cocktail doesn't wa

  • ABAP Code Question

    Hi experts, Need your input/s. Loop i_tab into wa_tab. read table i_tab2 into wa_tab2 with key...   if sy-subrc eq 0.   <b>  Modify the i_tab2 entry found by marking its QMSM-FOUND with 'X'.</b>  endif. endloop. How can I code this line:    <b>Modify

  • Bulk email from the database

    Good morning, Running Oracle9i Enterprise Edition Release 9.2.0.8.0 - 64bit Production... (we'll be upgrading to 11g soon, but for now, stuck with 9i) Our clients have requested an email subscription service to be implemented for our news web site. T

  • How to view video from a friend's web cam?

    Hello, A friend of mine from oversea is broadcasting a wedding through a web cam. I have a G3 pismo adn I am just wondering how and if I can view the wedding this coming weekend? He gave me the IP address and password, but I could get to the site bec

  • What does "You don't exist. Go away!" mean?

    I was using XCode 4.2 and was committing something to my local git.  After putting in the commit message and hitting the "commit" button I got an error reading "You don't exist. Go away!"  Additionally, terminal was non-functional after I got it.  I