Cyber Security: Context and Use-Case of a Self-Assessment Tool by ISPE/GAMP Italy Affiliate | In the complexity of pharmaceutical organization, it is particularly critical to assess cyber security posture without external consultancy support. The new Checklist for self-assessment developed by ISPE / GAMP Italian Affiliate is an interesting initiative to simplify the procedure. Through the Checklist it is possible to evaluate the whole organization (using common guidelines, requirements, and controls originated from ISO 27001). Furthermore, the tool has created having in mind the manufacturing systems (through IEC 62443 controls) and the new convergence challenges between IT and OT. Also, through the experience of a leading pharmaceutical company, we proved the alignment of outcomes with the more “prestigious” cyber security professional assessments.