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Document & record retention times

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by OrangeIsEnergy, Aug 10, 2015.

  1. OrangeIsEnergy

    OrangeIsEnergy Member

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    Hello, I am looking for some industry standard guidance on retention time for ISO 13485 certified systems. We manufacture single use IVDDs for professional use only.

    We are working on defining our retention times, because as a start-up, we have so far just kept all records forever, and we are to the point that we need to define disposal times. The specific types of records that I am questioning our retention time are:
    • Corrective Action/Preventive Action Requests
    • Customer Feedback
    • Internal Audit Reports
    • Management Review Meeting Records
    • Supplier Evaluations
    • Supplier approval documentation
    • Production cleaning records
    • Obsolete procedure and specification document revisions
    • Training records
    Any DHR records are to be kept for the lifetime of the product (defined as the shelf-life) plus 3 years.

    Any industry guidance people can give me (with reasoning if needed) on retention times for the above listed documents is appreciated!

    Thanks in advance! I'm so happy to have this forum reincarnate of the Cove! Thank you to all who run it and contribute! It is an invaluable resource for those of us new to the industry (like me)! :D
     
  2. Pads38

    Pads38 Member

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    From the MDD, Annex II Clause 6 - Administrative provisions
    "...a period ending at least five years (15 for implantable) after last manufacture..."
    Then gives a list of the documents to be retained.

    However, I cannot find equivalent requirements in the IVDD (Annex IV).

    Then in the Low Voltage Directive (a "general purpose" directive for non-medical electrical equipment) stipulates that records should be retained for 10 years after last manufacture.

    So no clear answer there. I wonder if this is an issue that will be covered in the proposed Regulations?
     
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  3. Nikki

    Nikki Well-Known Member

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    We are the in the medical compounding industry and keep our records for 15 years minimum.
     
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  4. OrangeIsEnergy

    OrangeIsEnergy Member

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    Even the non-product related records such as corrective action reports, internal audits, etc.? These are not related directly to a batch or lot of production. It is not defined specifically, so I am looking for industry examples and reasoning. I am considering using 10 years for these documents listed above, but can make arguments to keep some indefinitely... But that is probably overkill. Anyone have any reasoning to keep indefinitely, or is that just way too excessive?
     
  5. Scott Catron

    Scott Catron Member

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    Why not just scan them and keep them indefinitely?
     
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  6. Nikki

    Nikki Well-Known Member

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    We also scan all records. It makes them easily retrievable and definitely helps us save on space :)
     
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  7. OrangeIsEnergy

    OrangeIsEnergy Member

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    Just trying to save on time to do this with historical records. We now scan them all in, but for the past 5 years we didn't. And I still need to specify how long we keep the hard copies.
     
  8. Ronen E

    Ronen E Well-Known Member

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    Manage the risk.

    What is the risk in a specific type of record not being available for review / reference after X years?

    What is the risk in it not being available as original hard copy (but yes as a scan)?

    This will make you first ask yourself what all these records might be used for in the near and far future. Some interesting insights might await there.

    For storage / retrieval / backup of electronic records you could refer to the ISO 27000 series.
     
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  9. JCIC49

    JCIC49 Member

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    For all the documents that you have listed in the past I have used 25 years. The rationale for this can out of a discussion with an MHRA device reviewer. In that we were making a device for use on children, and if they had an issue with the device they had at the time to take legal action themselves from when thy were 18 for up to 5 years from this date, we then added a couple of years for safety.

    Since then I have had further input from a consultancy while working at another company that records should be retained for 50 years, the rationale for this was as in this company we were making implants that even though they had a 10 year declare life could still be in situation for years after this, which we had evidence for we should keep records for longer.

    As a result of these time periods the only option I believe is to scan and retain the records electronically. The key area to be considered on this is confirming that the scans are an accurate representative of the original hard copy document and this check will also produce a record, and where the electronic record is retained and can you still retrieve it in the scanned format for this time period.

    What you might want to think about is having two retention periods one for the hard copy and one for the electronic copy. Hope this helps
     
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  10. Scott Kruger

    Scott Kruger Member

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    for the records that you are talking about that don't necessarily have a direct relationship to the product life you have some leeway... Here's how I define mine:
    • Corrective Action/Preventive Action Requests - 10 years
    • Customer Feedback - 10 Years
    • Internal Audit Reports 10 Years
    • Management Review Meeting Records - 10 years
    • Supplier Evaluations -10 years
    • Supplier approval documentation -10 years
    • Production cleaning records - These go with the DHR for each product which is kept for 10 years and then we offer them to the customer for longer storage at their site (we are pretty much a contract manufacturer).
    • Obsolete procedure and specification document revisions - 10 years
    • Training records - 10 years beyond the employees date of termination

    That being said - it's up to the custodian of the record in question what to do after that 10 year period... they do not have to be destroyed and can be kept longer - so many of the records that are stored electronically will likely never be destroyed.

    We chose 10 years as a baseline because that exceeds our definition of the life of the product we make.

    CE marked product records follow MDD requirements.
     
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  11. OrangeIsEnergy

    OrangeIsEnergy Member

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    Thank you all for the helpful input. Since we make in vitro diagnostics, with minimal risk to users, and the longest shelf life is 2 years, I think that the 10 year retention time makes sense for us, and the electronic copies now being generated will be kept indefinitely. I appreciate the input and examples from everyone! I'm so thankful to have a forum to collaborate with peers!
     
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