Results 1 to 3 of 3

Thread: Transferring documents to new system

  1. #1
    Forum Member
    Join Date
    Nov 2016
    Posts
    36

    Transferring documents to new system

    Due to having to standardise our electronic document control system as part of our Pathology JV, we are having to transfer our documents (SOPs/ forms) from iPassport to QPulse . Does anyone know what the regulatory expectation is for having access to archived versions of SOPs? I have previously had to review older SOP versions when investigating incidents.

    Many thanks

  2. #2
    Forum Member
    Join Date
    Nov 2016
    Posts
    2
    Hi - all key activities should be traceable (EU GMP 4.8) and as you have already found you may need to prove what version of your SOP was in place at the time of an incident so retaining the versions of the SOPs that were in place at the time is necessary! EU GMP 4.12 covers the retention requirements but essentially it is up to you to define a Retention Policy that suits your needs and then ensures that secure controls are in place throughout the retention period (EU GMP 4.10).

  3. #3
    Forum Member
    Join Date
    Nov 2016
    Posts
    36
    Thank you Raitess, really helpful info and references.

Posting Permissions

  • You may not post new threads
  • You may not post replies
  • You may not post attachments
  • You may not edit your posts
  •