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  1. #1
    Oscar
    Guest

    Default Validation Summary report template

    Dear all,

    Somebody known what is the contents in a validation summary report?
    I need to create a validation summary report template but i don´t known what is the principal contents in this document.

    thanks for your comments

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  3. #2
    Forum Creator gokeeffe's Avatar
    Join Date
    Oct 2006
    Location
    Ireland
    Posts
    1,152

    Default

    YOu will need something like

    Table of contents
    Reference documentation
    Scope
    Introduction
    Results of execution
    Deviations noted
    Observations

    How to deal with Deviations and Observations (example some aspect might need a re-execution)

    Final summary detailing the result of the validation

    Hope this helps
    Graham O'Keeffe
    CEO and Founder
    Website: www.askaboutvalidation.com
    Forum: www.learnaboutgmp.com

  4. #3
    Validation Guru
    Join Date
    Sep 2007
    Location
    London
    Posts
    162

    Default

    Dear Oscar
    U dont need to bother for it, simply a Validation Summary Report provides an overview of what was accomplished and concludes the documentation. Yes as advised above Results of execution,Deviations and observation noted should be covered, and on the basis of this the action plan is decided by validation team.

    Regards,

    Shahid Ali
    QA Manager
    Addis Pharmaceutical Factory SC. Ethiopia

  5. #4
    leolikelion
    Guest

    Default Hi Oscar

    Validation Summary Reports provide an overview of the entire validation project. When regulatory auditors review validation projects, they typically begin by reviewing the summary report. The validation summary report should include:

    A description of the validation project
    All test cases performed, including if those test cases passed without issue
    All deviations reported, including how those deviations were resolved

    Summary reports should be signed by the System Owner and Quality Assurance. Once the summary report is signed, the validation project is considered to be complete.

    The collection of documents produced during a validation project is called a Validation Package. Once the validation project is complete, all validation package should be stored according to your site document rules.

  6. #5
    leolikelion
    Guest

    Default Hi All

    I am a beginner to the validation area. I have been trying to do self learning but I would need some help. Can somebody please suggest how do I go about it as where to start and how to start learning.

  7. #6
    Validation Expert
    Join Date
    Mar 2008
    Posts
    53

    Default

    Dear leolikelion,

    on the first, pls..do not make the same mistake like many of your colleagues from Val. Dept.!!!!
    First of all, you need to spend some time into production area, to see what happen there, to work toogether with other people, to see, recognize and learn all about process there, machines, devices, enviroment, legislatives..etc, etc..

    Once when you get a lot of expiriences, you could start validation.You need to KNOW how to do, also you need to FEEL.

    It is not like just seat and write procedure. Much experiences, much learning...after that..writing.

    rgds,

    cubica
    The Head of maintenance Dept. HPH

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