Communication Training and Curriculum Development

Compliance Training Documentation and Organization

  • 1.  Compliance Training Documentation and Organization

    Posted 08-15-2019 11:40 AM

    Curious how others keep their paper training documentation. I am a firm believer in keeping everything electronically and on paper.

     

    How do you keep your paper training documents? Do you have an individual file per employee? Or, do you keep your files per training document and date?

    Thank you for sharing 



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    Serena Beck
    Regulatory Ofcr
    Diatherix Eurofins
    Huntsville,AL
    serenabeck@eurofinsus.com
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    2020 SCCE Membership


  • 2.  RE: Compliance Training Documentation and Organization

    Posted 08-15-2019 12:26 PM
    Hi Serena,

    We avoid paper, but the point about redundancy is shared. We keep a regular backup of all data including training data, which is a combination of online training completions and trainer-indicated completion records in accordance with company policy and procedure.

    Where we do have paper, it is immediately scanned to a digital repository and the paper is shredded.

    The key in document retention is to be able to support how or why something happened and whether compliance with rules was met. So, you should be able to reproduce said documents, paper or electronic, based on whatever the audit calls for. We can do this at the individual employee level with our HRIS and digital repository.

    If you need to ask the question (Which is the better way to file: by employee or by training event?), my guess is either you are due for some monitoring exercises in this area that would test your system, or you are already doing it right because you can't tell which is the better path (you can get there equally well from either the "by employee" or the "by training event" inquiry approaches.) That would be true with or without the help of software or any digital solution, but software gives you the power to manage records at scale. If the latter (you're already doing it right for your org), my suggestion is try not to overthink something that may be working just fine and where changes may not lead to improved efficiencies. :-) My 2.5 cents anyway.

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    Chris Johnson
    Compliance Officer
    SyMed Corporation
    NAPA,CA
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    2020 SCCE Membership


  • 3.  RE: Compliance Training Documentation and Organization

    Posted 08-16-2019 09:54 AM
    Hi Serena:  We are moving from paper to electronic, but at the moment we have two systems - ComplianceWire for Compliance training, and scanned documents for Quality and Policy/Procedure training.  We have a general "Good Documentation Practice" policy which we follow - basically we retain per training, not per individual.

    I was part of an internal audit last year, where I had to demonstrate that appropriate people completed their required Quality training.  I provided a training matrix (a signed & dated PDF of an excel spreadsheet), and then pulled a training "read and understand" document for an individual on a specific training which was randomly selected by the auditor.  It's highly manual, but by keeping up with completion reports, I have high confidence in the process!

    Finally I should note that even for the electronic training in ComplianceWire, we have printed completion certificates which we retain the same way per our GDP policy.

    I hope that helps!
    Mona Kay

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    Mona Kay Gorman
    Director of Training
    Valeritas
    Hopewell,NJ
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    2020 SCCE Membership


  • 4.  RE: Compliance Training Documentation and Organization

    Posted 08-29-2019 10:55 AM
    We keep both electronic and paper. Once a year we print out a report showing all of the training completed during the year for everyone that took a course, current employees and terminated ones. We then file this report, not put something into each employee's file.

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    Carl Russell
    Compliance Analyst, CHPC
    Delta Dental of Idaho
    Boise,ID

    Anything I say is my sole opinion and not of my company.
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    2020 SCCE Membership


  • 5.  RE: Compliance Training Documentation and Organization

    Posted 08-30-2019 07:16 AM
    Unless there is a legitimate need such as some type of regulatory requirement, etc...or some other self prescribed commitment to do so by company policy...I ALWAYS opt for electronic copies of documents and then shred or destroy the paper copies.

    I think you will find a variety of different approaches as I know folks that save everything in all formats.

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    ► We don't fail unless we quit! ◄
    --------Frank Ruelas---------
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    2020 SCCE Membership