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Software Validation: Is 21 CFR §820.70(i) applicable to Minitab, Moldflow etc?

Discussion in 'US Medical Device Regulations' started by QAengineer13, Aug 24, 2015.

  1. QAengineer13

    QAengineer13 Member

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    21 CFR §820.70(i)

    (i) Automated processes. When computers or automated data processing systems are used as part of production or the quality system, the manufacturer shall validate computer software for its intended use according to an established protocol. All software changes shall be validated before approval and issuance. These validation activities and results shall be documented.

    Will this clause be applicable to software tools like Minitab, FEA and Moldflo etc which are used for design analysis and other design needs?

    I am aware and understand the FDA guidance document on Software Validation , the part which is not clear is the
    "Any software used to automate any part of the device production process or any part of the quality system must be validated for its intended use, as required by 21 CFR §820.70(i). This requirement applies to any software used to automate device design, testing, component acceptance, manufacturing,
    labeling, packaging, distribution, complaint handling, or to automate any other aspect of the quality system."

    Any clarity or feedback will be much appreciated!
     
  2. Ronen E

    Ronen E Well-Known Member

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    I think that the key term here is "automate".

    As far as I'm aware tools like Moldflow and other FEA are not used for "automating the design". They only provide input to "traditional" (i.e. human) design reviews.
     
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  3. QAengineer13

    QAengineer13 Member

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    Yes, I agree that's a very good point for Moldflow and FEA, but I strongly believe that we need to validate Minitab. Thanks for your input.
     
  4. Candi1024

    Candi1024 Well-Known Member

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    We validate Minitab. Since our use of it directly effects our decisions on the production floor.
     
  5. Gert Sørensen

    Gert Sørensen Member

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    All software used for quality activities in an FDA regulated company needs to be validated for its intended purpose. The point about automation is merely that you substitute a manual process - e.g. statistical analysis - with a software that performs the actions that you would otherwise have to do by hand.

    The validation can be quite simple, but you need to validate it against your intended purpose (calculations, access, backup etc. etc.).
     
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  6. QAengineer13

    QAengineer13 Member

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    Can you please define the term " Quality Activities" which you mentioned in your previous post . Thank you!
     
  7. Gert Sørensen

    Gert Sørensen Member

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    Quality activities are any activities covered by 21 CFR (you might call them predicate rules) including the current FDA interpretation of the regulation. So, if you use software to handle e.g. design, production, statistics, complaint handling etc. it needs to be validated for its intended purpose. This may sound daunting, but it need not be. The key words are "intended purpose". Be very specific about what you want to use the software for, and ensure that that is all you allow it to be used for, that will minimize your validation effort significantly.
     
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  8. BradM

    BradM Moderator Staff Member

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    I agree with Gert. The scope of your validation is dependent on what it is, and how it is used. Consider the following...
    Can anyone make wholesale changes in the application? If changes can (and are) made, does it follow applicable Change Control?
    Who verifies/approve/revokes access privileges?
    Does your application run on a server? What are the backup/archive practices?
    If IT is to make a change to the server, do they know to identify the application user?

    Covering all the basis for using this application is not only regulated, it makes for keeping the headaches low down the road. :)
     
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