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Gael Community » Q-Pulse customer forums » General Q-Pulse discussion » Q Pulse Validation :(

Q Pulse Validation :(

Last post 07-30-2008 11:04 by AlanH. 9 replies.
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  • 07-20-2008 23:21

    • mid_sa
    • Top 50 Contributor
    • Joined on 02-25-2008
    • Orthoplastics Ltd
    • Day
    • UK
    • Posts 15

    Q Pulse Validation :(

    Reply Contact

     

     I have reached to point where I can no longer ignore the need to validate our Q Pulse System and believe me ive been trying. I was wondering if Gael provides any support documentation package for

    • The initial software package provided i.e. some form of Validation documentation / Part 11 compliance capability statement (Just for the software package as supplied).
    • Also some information to enable us to justify Gael as an appropriate supplier of this type of product,

    Any help on this would be much appreciated.

    Also any tips on validation of a system like this my initial OQ plan is begining to look like a 2050 completion date. 

  • 07-22-2008 11:28 In reply to

    • kevinm
    • Top 75 Contributor
    • Joined on 02-07-2008
    • Glasgow
    • Scotland
    • Posts 7
    • Staff

    Re: Q Pulse Validation :(

    Reply Contact

    Q-Pulse Validation Support.zip

    Hi Mark,

    Thanks for your post, I have uploaded our internal validation documentation that should be useful.

    We are currently developing a validation service with a view to it being available this year.

     Regards,

     K

     

    Kevin McSharry
    Upgrade Manager
    Gael Ltd

    t: +44 (0)1355 593 423
    f: +44 (0)1355 579 191
    w: www.gaelquality.com

  • 07-22-2008 12:55 In reply to

    • mid_sa
    • Top 50 Contributor
    • Joined on 02-25-2008
    • Orthoplastics Ltd
    • Day
    • UK
    • Posts 15

    Re: Q Pulse Validation :(

    Reply Contact

     Many Thanks for that I will Now start reading

     

    M 

  • 07-22-2008 13:03 In reply to

    • Daniel Rae
    • Top 10 Contributor
    • Joined on 12-14-2007
    • Gael Ltd
    • East Kilbride
    • Lanarkshire
    • Scotland
    • Posts 902
    • Staff
      SystemAdministrator

    Re: Q Pulse Validation :(

    Reply Contact

     Let us know if they help at all! Yes

    Daniel Rae
    Web Community Champion
    Gael Ltd

    t: +44 (0)1355 593 435
    f: +44 (0)1355 579 191
    w: www.gaelcommunity.com

    View Daniel Rae's profile on LinkedIn

  • 07-23-2008 14:26 In reply to

    • Deb Collins
    • Top 150 Contributor
    • Joined on 06-11-2008
    • Rhode Island Blood Center
    • Providence
    • Rhode Island
    • US
    • Posts 2

    Re: Q Pulse Validation :(

    Reply Contact

    Kevin,

    Could you send me whatever validation documents you have as well.  We have version 5.2 and will need to validate the system for at least the Document module. I am not an IT tech so I'll need whatever help I can get. We have not yet purchased the add-on for Part 11 compliance but we'll need to when we start working on the Document module.  Thanks.

     

    Deb Collins, QA/Compliance Specialist

  • 07-23-2008 15:12 In reply to

    • Daniel Rae
    • Top 10 Contributor
    • Joined on 12-14-2007
    • Gael Ltd
    • East Kilbride
    • Lanarkshire
    • Scotland
    • Posts 902
    • Staff
      SystemAdministrator

    Re: Q Pulse Validation :(

    Reply Contact

    Deb,

    The files Kev sent are above attached to his post as a Zip file.

    Click here to download the file.

    Daniel Rae
    Web Community Champion
    Gael Ltd

    t: +44 (0)1355 593 435
    f: +44 (0)1355 579 191
    w: www.gaelcommunity.com

    View Daniel Rae's profile on LinkedIn

  • 07-24-2008 22:04 In reply to

    • LoriW
    • Top 100 Contributor
    • Joined on 06-05-2008
    • ECL2 Consulting Services LLC
    • Grapevine
    • Texas
    • Posts 3
    • Partners

    Re: Q Pulse Validation :(

    Reply Contact

    Deb,

    I am currently providing validation services to another Gael client that has just implemented Q-Pulse.  I would be happy to set-up a call with you to discuss how we can be of service.

    Lori J. Wright

    ECL2 Consulting Services LLC

     

  • 07-24-2008 22:09 In reply to

    • LoriW
    • Top 100 Contributor
    • Joined on 06-05-2008
    • ECL2 Consulting Services LLC
    • Grapevine
    • Texas
    • Posts 3
    • Partners

    Re: Q Pulse Validation :(

    Reply Contact

    My company has just started providing validation services to another Gael client for Q-Pulse.  We would be happy to assist you with your project.

    Lori J. Wright

    ECL2 Consulting Service, LLC

    phone: (469)955-9556

     

  • 07-29-2008 16:23 In reply to

    • Deb Collins
    • Top 150 Contributor
    • Joined on 06-11-2008
    • Rhode Island Blood Center
    • Providence
    • Rhode Island
    • US
    • Posts 2

    Re: Q Pulse Validation :(

    Reply Contact

    Lori,
    Thank you for the response. 
     
    We are not yet ready to validate, as we are just in the beginning stages of development for the Audit and CAPA modules, with implementation of the Document module to come later.  I was looking for some preliminary information about available validation support.  Do you provide assistance with the actual validation process, i.e., IQ, OQ, PQ and written reports, or just validation scripts?  Any information would be helpful.

  • 07-30-2008 11:04 In reply to

    • AlanH
    • Top 10 Contributor
    • Joined on 01-25-2008
    • Gael HQ
    • Scotland
    • Posts 40
    • Staff

    Re: Q Pulse Validation :(

    Reply Contact

    Hi Deb

    It is our intention to provide a range of validation services for clients in the near future and we are working with Lori and existing customers to develop these.

    Please feel free to get in touch when you are ready to discuss validation.

    In the meantime please e-mail me and I will forward you our current validation support pack alanh@gaelquality.com

    Cheers

    Alan

     

    Alan Hiddleston
    International Solutions Consultant
    Gael Ltd

    t: +44 (0)1355 593 417
    f: +44 (0)1355 579 191
    m: +44 (0)7780 683 852
    e: AlanH@gaelquality.com
    w: www.gaelquality.com
    webex:http://gael.webex.com/meet/AlanH
    http://www.linkedin.com/pub/4/b90/328
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