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Writing & Executing a Software Validation Protocol: Plain and Simple

Writing & Executing a Software Validation Protocol: Plain and Simple


This quick and easy guide describes methods and approaches for writing a validation protocol that can help ensure a thorough validation effort. It also provides some tips and tricks on executing the protocol and documenting the results.

While this book was written primarily for those new to validation projects and the effort required gathering sufficient evidence to support validation claims , experienced folks will likely find nuggets to help improve their efforts.



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  1. 03-31-2012, 01:59 AM #1
    Dhanush
    Dhanush is offline
    Validation Analyst
    Join Date
    Mar 2012
    Posts
    1

    Lightbulb USP Method Verification of Heparin Sodium API Identification using HPLC

    Hi,

    I am performing USP method verification of Heparin Sodium API Identification using HPLC. Is it necessary to perform Robustness apart from specificity and solution stability? If yes, which parameters can be varied to verify that method remains unaffected by minor variations in parameters?

    Thanks,

    Dhanush
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  2. 05-27-2012, 02:44 PM #2
    RohitHirpara
    RohitHirpara is offline
    Validation Analyst
    Join Date
    Aug 2009
    Posts
    7

    Default

    No need to perform robustness,if as such method feasible for test
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