5th September 2018

Attendees: Anders, Evi, Martjin, Susane

Apologies: Tony, Richard, Stuart, Bob, Daniel

Agenda:

• 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
Action

• Anders to invite Martjin to a working meeting