Projects in regulated environments have to follow strict guidelines and rules. Laws, normative regulations, product risk analysis, and detailled development processes are defined and controlled by Quality Management departments. Besides of that you have to deal with external groups like editorial staff for documentation. From a User Story's point of view all of the following is necessary for a proper Definition of Done: Done: internal Scrum DoD (specified, implemented, unit tested, reviewed, UI tested, integrated, and so on) Done-Done: external Documentation DoD (readme edited, online help edited, user manual edited, translated, layouted, printed) Done-Done-Done: external System Release Testing DoD (regression tested, all stories tested, documentation tested, system interoperability tested, etc.) Done-Done-Done-Done: external Quality Management DoD (risks analyzed, overall risks reviewed, remedial actions defined, project documented, ...
