How Agile in General Supports Work in Regulated Environments

ABOUT THIS CHAPTER   The early Agile focus on flexibility at all costs created the impression that Agile practices were not well-suited for regulated industries such as life sciences, finance, and government. The focus on “go full Agile or go home” reinforced the impression that Agile practices were not applicable for companies that could not see how to make their customers or their overall product development cycles fully Agile.

This was unfortunate, because so much software is developed under overt regulations, including FDA, IEC 62304, ASPICE, ISO 26262, FedRAMP, FMCSA, SOX, and GDPR. And other software that might not seem regulated can still be subject to rules for privacy, accessibility, and ...