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Discarding Hard Copy of Records?

Discussion in 'Documentation Control, Procedures, Templates,...' started by QA Bee, Mar 21, 2017.

  1. QA Bee

    QA Bee Member

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    We are an early stage medical device company and everything is electronic including our QMS and ERP etc.

    Although, We may have some hard copies of records that we don't want to store but the plan is to scan and retain the records electronically.

    Now, The key point is that to we want to confirm that the scans are an accurate representative of the original hard copy document and we are thinking of having someone stamp "Scanned & Verified By/Date and # of pages" stamp hard copies and then scan it in to PDF.

    Will it be ok to discard hard copies after? Or Is there a need to keep hard copies?
     
  2. yodon

    yodon Active Member

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    Seems stamping the hardcopy with an assertion of scan accuracy is putting the cart before the horse but confirming the scans are accurate is the right approach.

    Once you do confirm the scan is accurate, you would not need to keep the hardcopy.

    That said, you do now bring in 21 CFR Part 11 into play. You'll also want to ensure your system is compliant with that (control of electronic records).
     
  3. Said BELAJ

    Said BELAJ Member

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    Hi,

    All depends on regulatory requirements and to contract issues of your firm with other parties
    Find out if it is stated in theses requirements if you need to keep the original of hard copies.

    Regards,
     
  4. RoxaneB

    RoxaneB Moderator Staff Member

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    Said BELAJ, considering the original poster asked this question in March 2017 (and was last online in January 2018), you may wish to consider the length of time that has passed before posting a response.
     

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