Regulatory Open Forum

 View Only
  • 1.  Migration from paper-based to electronic DMS

    Posted 02-Oct-2019 06:05
      |   view attached
    Hi Everyone,

    Our company is in the process of migration from paper-based to electronic quality document management system.

    Technically the transition is done by the respective scanned copies (that contain manual signatures) upload on system in the 'draft' state with subsequent approval of the imported electronic object which after being approved electronically is assigned with the 'version 1' by default.
    In result after the migration each of the uploaded documents will have two sets of headers (see attached) with different version numbers - and those are the documents that will be pushed to the LMS for employees training.

    Did anyone have similar experience and how did you managed such change control, especially with respect to
    - versioning difference between uploaded pdf files of original paper copies and a virtual object that corresponds to it in the system
    - difference between paper copies approval dates and electronic version approval in the system

    Thank you in advance for any thoughts!

    ------------------------------
    Julia Ershova
    Moscow
    ------------------------------


  • 2.  RE: Migration from paper-based to electronic DMS

    Posted 03-Oct-2019 12:59
    Hi Julia,
    I would suggest that you use your CAPA or equivalent Continous improvement process to "roll out" the new eQMS.  Using a documented change/improvement plan will give you the ability to document the 'expected' behavior of these hybrid docs(existing offline docs coming into your eQMS) as they are brought into the new system. Assuming much testing has been done in the sandbox/test environment to push the limits of the new system and you are already aware of the other similar limitations.  One could also create a support document for the users on how to read/utilize these historic documents. In other words, a guide to "de-code" the versions, dates, etc. 


    ------------------------------
    Kamran Younis
    Mr
    Butler NJ
    United States
    ------------------------------