When it comes to compliance management, software teams apply various development methods to build systems that have the highest quality while meeting the regulatory standards. Although tighter compliance regulations are challenging organizations in a variety of ways, those who leverage compliance management best practices and adapt quickly will enjoy a distinct competitive advantage.
Sequential approaches to development, such as Waterfall, generally fall short of the compliance requirements you will need in the regulatory compliance environment. This is because Waterfall methodology usually mandates that full system specifications are defined and committed to in detail, up front, and long before the real system behaviors can be known.
Waterfall’s sequential nature produces large batches of work, long cycles between system integration points, and late feedback. Furthermore, compliance management activities are typically deferred until the end of the project, providing little insight into compliance progress.
This approach does not scale, nor can it keep pace with accelerating time-to-market demands. This often results in missed deadlines, disappointing outcomes, lower quality, lateness and significant compliance challenges.
In contrast, high-assurance Lean-Agile development builds in quality incrementally—early and throughout the development lifecycle. And they do so while including the very elements and activities necessary to ensure compliance.
Business Analysts (BAs) and product owners must get the compliance requirements right.
Development processes such as Agile and DevOps – with their emphasis on adaptive planning, continuous improvement, and flexible response to changing circumstances – lend themselves well to a fast-changing regulatory environment.
When we talk about Agile and other Lean methodologies, it’s important to remember that most projects are hybrids. Specifically:
With these trends in mind, BAs and product owners can follow best practices for creating regulatory compliance requirements.
BAs and product owners should begin by focusing on understanding the compliance requirements. It’s a delicate balance because software development methodologies like Agile or DevOps do not emphasize up-front analysis. So while you shouldn’t get stuck in “paralysis by analysis,” it’s important to take the time to get a thorough understanding of the compliance requirements facing your organization and industry. The practice must be ongoing. The compliance landscape is changing constantly, so BAs must always stay on top of regulatory changes.
BAs must identify their organization’s regulatory stakeholders and engage them effectively. The means working closely the legal, compliance, risk management, audit, and operations professionals to ensure requirements meet the compliance demands.
This best practice is a fundamental part of the DevOps software methodology process. DevOps strives for expanded collaboration between the development and operations staff throughout all stages of the development lifecycle.
BAs and product owners using Agile and DevOps development processes should leverage those collaborative relationships by practicing superior communication with their business units. BAs and product owners should reach out early and make valuable use the stakeholders’ time by having research done and questions ready. As DevOps strives for greater alignment between development teams and operational units, these best practices of communication and collaboration will be essential.
Wherever possible, BAs should automate their processes. Automation is a driving force across all industries as IT professionals strive to add more speed and quality to their previously manual tasks. In the regulated sector, automation will accelerate delivery through capabilities that ensure compliance with regulations and standards.
As the work moves quickly within Agile or DevOps projects, automation can help ensure consistency and overcome the risk of error associated with the human element.
Effective software teams often use visual models to improve their understanding of business processes. Visual models lead to deeper conversations to developing better requirements. Business process models, in particular, improve understanding to help teams understand the impact of regulatory change.
To mitigate the regulatory risk, organizations must have a system of record showing traceability to compliance regulations. Traceability between business objectives, requirements and tests will help the development teams ensure nothing is missed, while protecting the organization in the case of an audit. Stakeholders from the business or compliance units must also communicate and collaborate with the Agile and DevOps teams to make sure the new releases meet regulatory standards.
Compliance requirements frequently affect multiple projects and systems and change quickly, making them prime candidates for reuse. BAs and product owners should make it a priority to create a shared, centralized repository of compliance requirements. This includes requirements related to access, security, data confidentiality, data availability, authentication, logging, and auditability. Development teams can use these compliance requirements as reference items for other projects.