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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.



View Poll Results: What problems to you currently face with batch records?

Voters
13. You may not vote on this poll

  • Lost documents

    4 30.77%

  • Slow approval times

    3 23.08%

  • Version contol

    0 0%

  • Incomplete records

    8 61.54%
Multiple Choice Poll.
Results 1 to 6 of 6
  1. 03-13-2012, 09:23 AM #1
    gokeeffe
    gokeeffe is offline
    Forum Creator gokeeffe's Avatar
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    Default What problems to you currently face with batch records?

    What problems to you currently face with batch records?

    If you would like to explain your choice further please use this thread.

    Regards
    Graham O'Keeffe
    Director of Operations
    Premier Validation Ltd
    Website: www.premiervalidation.com
    Forum: www.askaboutvalidation.com
    LinkedIn: LinkedIn Profile

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  2. 03-13-2012, 09:51 AM #2
    DURGA PRASAD
    DURGA PRASAD is offline
    Validation Guru
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    Default

    Hi Graham,
    Its a great start in polling section.
    I would say that the top most miseries in a manufacturing shop floor regarding a Btach manufacturing records are Lost documents or attachments and Incomplete documents.
    Durga Prasad
    Internal Consultant,Aseptic Process-NNE Pharmaplan
    www.nnepharmaplan.com
    Denmark
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  3. 06-12-2012, 07:30 AM #3
    gtf
    gtf is offline
    Validation Analyst
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    Switzerland
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    Default

    When I was providing service in many cases we faced lost signatures of electronic documents

    Cheers gtf
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  4. 07-23-2012, 05:35 AM #4
    maavan
    maavan is offline
    Validation Analyst
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    Jul 2012
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    Default

    many time i face slow work
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  5. 07-28-2012, 12:24 PM #5
    graveemma
    graveemma is offline
    Validation Analyst
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    I think Lost Documents is the major problem with this.
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  6. 08-26-2012, 10:14 AM #6
    deshivenugopal
    deshivenugopal is offline
    Validation Analyst
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    Oct 2009
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    Default

    Hi !

    Besides lost of documents, lots of errors in Batch records include typo errors, over writing and wrong observations.

    Venugopal
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