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Documentation of validation and qualification protocols

Discussion in 'Qualification & Validation (21 CFR Part 11)' started by Abdullah, Jan 11, 2016.

  1. Abdullah

    Abdullah Member

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    Dear all,
    I hope you are having a great time where ever you are ^_^


    i have a question which is:
    when a qualification or a validation protocol for a particular equipment or process is approved and it needs to be executed, where shall the actual readings be written ?? i mean on the same tables and fields within the same protocol or they will be documented on a separate forms the same as those prepared in the protocol.
     
  2. Somashekar

    Somashekar Moderator Staff Member

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    Its common to follow the "Protocol" and the "Report" in a validation exercise. So I guess for your question, the separate form as made in the protocol shall have the actual readings being a part of the report. Hope this answers your question...
     
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  3. Abdullah

    Abdullah Member

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    so i need to prepare the protocol with empty tables and forms, then make a report including the same tables and forms to fill the actual results on it ?!
     
  4. Somashekar

    Somashekar Moderator Staff Member

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    Yes. The empty tables and forms in the protocol are typical, and can be with just an example field for the data. The report tables and forms runs down to as many trials as you make in your validation attempts. Hope this clarifies.
     
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  5. Vthouta

    Vthouta Member

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    In my past experience, I have listed all the requirements in the protocols and designed user friendly forms with empty tables and headings. I general, you could report all the findings in the validation report. Summarize the findings and observations recorded as part of the verification and validation process.
     
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  6. Abdullah

    Abdullah Member

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    ok thats great, but there is one more thing; according to ISO 13485, it is required to control each document according to a documentation system. so do i need to give each protocol / report an issue number, issue date and signature,...etc ??
    or it is applicable to attach the report to the prepared protocol without giving document number ?!!
     
  7. QAengineer13

    QAengineer13 Member

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    I am not sure whether your organization comply with FDA ? If you do please ensure you follow 820.40 (a) Document approval and distribution and (b) Document Changes. Clearly you need to have a unique report document number (DHF #) Revision and author , Reviewer/approver for the report even if its just ISO 13485 or according to 21 CFR 820.40.
     
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  8. Somashekar

    Somashekar Moderator Staff Member

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    The protocol is your validation document. This revision must be current, and under the document control.
    The report is the validation record. This must follow the most current protocol and be under your records control. You could be making multiple validations and therefore so many reports (records) using the same valid protocol.
     
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  9. Candi1024

    Candi1024 Well-Known Member

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    I understand his confusion :)

    At certain companies, we would write a protocol and it would be approved. Then we would use that exact printed protocol and fill out the form (making it a record). The document number on the protocol would therefore be at the bottom of the record, since it is the form. It would be the executed protocol.

    At other companies, we would be required to take the protocol, and change certain things like the footer and the title, to make it into a record with a new document number. Then execute that new document. I have an issue with this but I have a hard time getting others to see it my way. (or maybe my view is just not quite correct, lol!)
     
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  10. Abdullah

    Abdullah Member

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    Exactly thats it :p
     
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