After internal audits it was requested to implement a new security model, eTMF compliant for the Clinical trial document management system
Running and facilitating solution & design workshops and requirement gathering sessions, structuring and documenting the new features on a Documentum security project
Negotiating over business requirements in order to ensure same security model is applicable within Vaccines and Pharma devisions
Helping the vendor to win the implementation BID of the project
CARS project - two clinical communities: CLRD and EPI (from Vaccines devision) and one pharma community has joint their forces in harmonising the internal processes in terms of accessing critical sensitive informations related to their research trials. The trigger of this journey was a CAPA finding over their internal auditing of the CARS system.