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Part 11 References

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  • Computerized Systems Used In Clinical Investigations

  • Computerized Systems Used In Clinical Trials

  • Part 11 Scope and Application

  • General Principles of Computer System Validation

  • Computer Systems Validation Guidelines

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    Username Post: the content of module 3? (CTD)        (Topic#3806)
    orange-juzi 
    Beginner
     Posts: 3
    03-24-08 01:08 PM - Post#4630    



    the CTD is organized into five modules. i have found a model Quality Overall Summary for capsules, but i don't know how to prepare Module 3. i have looked through the content of 'ANDA checklist for cCTD or eCTD format for completeness and acceptabulity of an application for filing ' several times and discoverd that the content required in moudle 3 is similar to the QOS. so i wander whether they are the same.
    please help me, provide a model of Moudule 3







     
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