5th September 2018
From PHUSE Wiki
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