5th September 2018

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Attendees: Anders, Evi, Martjin, Susane

Apologies: Tony, Richard, Stuart, Bob, Daniel


  • Follow up on actions
    • Bob, Tony, Daniel and Anders are expect to deliver the report in October
    • Bob is starting the Lean chapters but expect to be finished in September
    • All to think of examples of usage in different GxP domains
    • Have raw text of how this is used
    • Upload the input or send to Anders to discuss on the next call
    • Example in the pre clinical domain will be helpful - Martjin to
    • Evi, Martjin and Anders all have examples and write in RAW text and go into a more editorial mode once the team have agreed

  • Evi - Working on the definition chapter based on ISO and NIST this is to complete this by September in RAW text form
  • Martjin and Anders - Paragraphs section - Both to get together and discuss what works and what are good leads for Martijin to start working on

  • Audit of cloud service providers
    • Evi - we try to leverage as much as of the existing certifications that already exists supporting cloud
    • We have hired a firm to do a Gap analyses of our capabilities
    • We collect a whole library of these questions and how we would answer them
    • We are audited 6-10 times a year for two days and review the artefacts to show we do what we do
    • Anders - Appendix should describe which topics should be taken into consideration
    • Evi - Much of the work that is being done today is highly automated which makes it difficult to provide artefacts
    • Evi - How do you validate the use age?

  • Validation approach to cloud - has been put on hold although we do still want an appendix
  • Cloud Migration - What challenges could there be ? discussion is more on moving from one provider to another?

AOB Martijin OOO - Last week of September and first week of October

  • Anders to invite Martjin to a working meeting