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What are some alternative methods to 100% validation that will produce similar results but at reduced costs?

  • 07 Mar 2012 7:09 AM
    Message # 850318
    Anonymous member (Administrator)

    One approach is to apply adaptive validation strategies too present 100% validation.  You may want to work with a statistician to create a validation SOP with the detail process.  Remember, FDA does not require pharmaceutical companies to perform 100% validation all of the time.  FDA does require, however, that whatever critera you define for validation is correctly applied and that you are confident in your results.

    One method is to start at 70% validation and increase or decrease percentage based on qc issues found from the first clinical study.  For similar clinical studies with the same compound, it makes sense to leverage this knowledgebase for repeated savings.  You can adjust as needed when adding or removing known problem sites or lab vendors.

    A second method may be to validate based on three risk categories: High (90-100%), Median (70-90%), or Low (25-70%).

    2.Vali

     

  • 08 Mar 2012 5:58 AM
    Reply # 851560 on 850318
    Anonymous member (Administrator)

    You can download my recent IFSUG presentation on 'Minimizing Impact and Risk of Bad Data – Lessons from Other Industries'.

    http://sassavvy.com/Resources/SAS%20Downloads/Minimizing%20Impact%20and%20Risk%20of%20Bad%20Data%20_%20Lessons%20from%20Other%20Industries.pdf


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