Achieving Regulatory and Industry Standards Compliance with SAFe

One of the new advances we introduced in SAFe 4.5 and have continued to evolve in 4.6 is the content related to implementing Lean-Agile in an enterprise with significant compliance concerns. You will find Compliance in the Large Solution level as a callout from Solution Intent.

This article is supported by a more detailed white paper, Achieving Regulatory and Industry Standards Compliance with the Scaled Agile Framework® (SAFe®), which you can download here. In addition, there is a SAFe webinar on the topic, with Q&A, which can be viewed here.

Apply Lean-Agile Principles and Practices to Achieve Compliance

The Compliance article helps those organizations building complex systems subject to regulatory and industry compliance standards apply Lean-Agile principles and practices to product development. These systems often have an unacceptable social or economic cost of failure. Examples include medical devices, automotive, defense systems, banking, pharmaceuticals, and more. The rigorous compliance processes associated with these industries have historically led to quality management systems that follow a phase-gate waterfall lifecycle model. In fact, many practitioners in these markets simply assume that a Lean-Agile flow-based approach simply will not work in their context.

The compliance article in SAFe 4.6 offers specific success patterns that have been implemented with great results in these high assurance industries. It illustrates how Lean-Agile and compliance goals coexist using SAFe to make progress more visible and to incorporate compliance activities into product development early and throughout the regular flow of work. Continuous and fast feedback regarding compliance issues actually produces better outcomes than our historical patterns of enforcing compliance at the end as part of a single “big bang” delivery.

Download the SAFe® Regulatory and Compliance Toolkit for SAFe Program Consultants (SPCs)

This toolkit is for SPCs who need to present SAFe in the context of industries and programs that must demonstrate compliance. It includes a PPT presentation as the primary tool as well as referencing the white paper and webinar. SPCs can download the compliance toolkit on the SAFe Community Platform here.