Implementing Agile in a regulated environment can be challenging, on one hand companies would like to deliver value to their customers as fast as they can. On the other hand some of the regulated requirements slow them down and force them to go through predefined checks and balances, create a lot of documentation, massive testing, quality activities, communication with external parties and more.
With all of that it is still possible to add some modifications to the traditional Agile approach so it will fit and even better manage the activities through smart workflows so regulated companies can still keep on high productivity and bring the overhead on the engineering team to the minimum possible.
As a first step, Identify the regulatory requirements upfront and ensure that they are incorporated into your development process. This will help you avoid compliance issues and ensure that your process meets all regulatory requirements and help you understand how much flexibility you have in your approach and what has to be added to the standard Agile implementation. Then select an Agile framework that aligns with your organization’s regulatory requirements. Most of the popular Agile frameworks can be adapted for regulated environments including Scrum, Kanban, and Lean. However the key will be with the workflow being used within the framework.
Once done, as always, involve all the relevant stakeholders. This will help to ensure that all regulated requirements are covered and everyone is on the same page. Conduct a thorough analysis of the regulations that apply to your product or service and make sure that any requirements that may impact the development process is covered.It is highly recommended to review the outcome with a regulatory expert.
Incorporate the regulatory requirements into your user stories, acceptance criteria, and test cases. The key is to include all the regulatory requirements throughout the development process and that the final product meets all necessary regulatory requirements. This also includes any documentation and reviews needed that will provide evidence of compliance if needed.
Test early and often as testing is a critical component of Agile, and it’s especially important in a regulated environment. Plan for testing early and often, and incorporate it into your Agile process. This will help you identify any compliance issues early on and avoid costly delays.
Monitor changes in regulations and update your regulatory compliance plan and development process accordingly. This will ensure that you stay up-to-date with any changes in regulatory requirements and that your product remains compliant.
Overall, implementing Agile in a regulated environment requires careful planning, stakeholder involvement, and a willingness to adapt to changing requirements. By smart planning, you can still successfully implement Agile in a regulated environment and deliver compliant products.
