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Agile in Highly Regulated Environments

Audit requirements and strict compliance processes can be handled with the right Agile method.

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Highly regulated environments like healthcare, financial services or governments require audit requirements and strict compliance processes - which are often against the literal understanding of the Agile Manifesto. The idea of focusing on working software instead of comprehensive documentation can result in Agile processes being rejected without a consideration.

The author proposes that the selection of the method to be adopted must match the types of regulation the teams are working with. In his experience, the reporting requirements fall into two types: prescriptive and descriptive rules. Descriptive rules seek to systematize the production so as to increase repeatability (like the ISO 9001 Standards), and are more suited to Scrum. Prescriptive rules are meant to create contracts and govern behavior, and are more suited for Kanban.

Tough Scrum is the most popular Agile framework, it is not the only choice. Agile practices drive engaged and empowered teams that optimize their work while meeting audit-ability, traceability, and regulatory requirements.
Created on Oct 22, 2020 22:57,
last edited on Oct 23, 2020 10:41
Revision #1