Mark is IT Compliance Director and GXP subject matter expert within AstraZeneca's global IT Organisation. He is a Chartered Engineer, and has been with AZ for 19 years and was previously with GSK for 12 years in a variety of computer compliance and engineering roles. Mark is a member of ISPE GAMP Global and European Steering Groups, and co-leads the GAMP Agile Special Interest Group.
Agile Software Development in GxP Regulated Environments GAMP® Special Interest Group
User Requirements (Specification)
Successful delivery requires ensuring we build the right system that is fit for the intended use, not just ensuring we build the...
Then and Now – From Certainty to Discovery Mindsets
Advancement in technologies have forced organisations to rethink business models. Organisations that were once controlled and orderly are now more chaotic and complex, serving patients and customers...
There is sometimes a perception that computer systems validation requires a V-Model approach using a waterfall methodology. This means all requirements must be agreed before design can progress and in turn all design must be signed off before the system...