Joanne C. Donald

Roche Products Ltd
Global Computerized Systems Strategy Lead (CSS)
Joanne Donald is currently a Global Computer System Lead at Roche’s Pharma Development Quality organization. She has a broad range of QA and validation experience and has worked on GLP, GMP, GVP, GCP and Medical Device regulations at different stages over the course of her career. She is a proven expert on GxP computerized systems compliance and more recently how to validate AI and ML technology.
She authored, a Roche AI Validation Guidance and is currently leading a cross GxP (GLP/ GCP/GVP/GMP,MDR ) AI Squad which is authoring key AI validation deliverables and tools to enable the quick adoption of AI solutions across Roche.
Joanne has delivered presentations at numerous industry conferences, and published industry articles. She is currently a member of the AI Clinical Contract Research / E Clinical Forum, and the GAMP® SA & AI Special Interest Group. She is on the board of Research and Quality and Assurance (RQA).

Related Articles

The Machine Learning Life Cycle (MLLC): Key Artifacts, Considerations, and Questions
iSpeak Blog
The Machine Learning Life Cycle (MLLC): Key Artifacts, Considerations, and Questions

It is an exciting time in life sciences. Many companies have focused initial artificial intelligence/machine learning (AI/ML) adoption efforts on developing and implementing ML trained algorithms, which necessitate following a controlled approach such as the GAMP® 5 ML Sub-System methodology shown below. This blog highlights key artifacts and considerations when implementing AI/ML for GxP use...