Agile VS Compliance (english version)

Regulatory Compliance in the Agile-Scaled Environment: A Guide to integrating Regulatory Standards

In today’s dynamic business world, many organisations face the challenge of scaling agile practices while meeting regulatory requirements. This article provides a guide to integrating regulatory compliance in an agile-scaled environment and shows how organisations can harmoniously combine both aspects.

Basics of Regulatory Compliance and Agile-Scaled Environment

An agile-scaled environment describes the application of agile principles to large organisations. Frameworks such as SAFe, LeSS, and Nexus are prime examples of scaling agile practices and frameworks to numerous teams and complex projects, aiming for iterative development, rapid adaptation to changes, and continuous improvement. Additionally, the focus is on fewer formal processes, moving towards self-organisation, team-driven decision-making and minimal bureaucratic effort.

Regulatory compliance, on the other hand, means adhering to laws, regulations and standards to ensure the quality and conformity of products and processes. In other words, there are not only regulations related to products but also how two companies may exchange information due to confidentiality guidelines.

In some industries, regulations are essential, even for agile teams.

In some sectors, regulations are essential, even for agile teams. Examples include medical technology and the automotive industry, where both product details such as materials and adherence to process requirements must be considered.

regulatory compliance topics can arise in various ways. Here is a list of the most well-known regulations:

• CENELEC: European Committee for Electrotechnical Standardisation
• FDA: U.S. Food and Drug Administration
• ISO 13485: Requirements for a comprehensive quality management system for the design and manufacture of medical devices
• Federal Aviation Administration: Federal Aviation Administration of the United States
• ISO 26262: Safety-related electrical/electronic systems in motor vehicles -> V-Model
• MISRA: Motor Industry Software Reliability Association, organisation that creates guidelines for the software of electronic components in the automotive industry
• BSI: (British Standards Institution) globally active standardisation organisation for the development of standards, training, auditing and certification; BSI tests and evaluates products and management systems worldwide according to internationally applicable standards in companies in various industries
• ANSI: American National Standards Institute, organisation for coordinating the development of voluntary standards
• A-SPICE: Basis for improving and evaluating your work processes

Why should regulatory compliance issues be considered and implemented early?

Early regulatory compliance integration, which continuously monitors regulatory compliance requirements for the process, enables problems to be recognised at an early stage. In addition, adherence to regulatory compliance standards leads to a significant increase in product quality. By ensuring that all regulatory requirements are met, the overall quality of the product is improved and compliance with legal regulations is guaranteed.

Where should Regulatory Compliance Topics be Considered in the agile envrionment? How can Practical Compliance Implementation Steps look like?

Compliance specialists should be involved in the creation of backlog items as well as in planning and refinement events. In addition to the actual backlog items, regulatory compliance requirements can also be reflected in the Definition of Ready (DoR) and Definition of Done (DoD). Regular audits and reviews can be implemented for each iteration and ensure that standards and regulations are adhered to. In addition, regulatory compliance metrics can be regularly reviewed and adjusted in the next iterations to ensure continuous improvement and adherence to standards. Continuous integration (CI) enables immediate review of changes and creates traceable links between requirements and implementations (requirement traceability). Automated tests continuously check regulatory compliance requirements, while verification and validation (V&V) confirm regulatory compliance with these requirements.

Conclusion

Integrating regulatory compliance into an agile scaled environment may initially seem contradictory but offers numerous advantages. Through a structured approach, companies can harness the flexibility and innovative power of agile methods while meeting necessary regulatory requirements. This creates a harmonious combination that enables high-quality and compliant products.

A few more tips for further article:

• If you want to learn more about RE and agile development, please read this blog post.
• If you want to learn about agile product development methods, I recommend our CARS course. Use cases, user stories, acceptance criteria and much more – you will learn the theory and practice.

Do you also have problems with compliance in agile product development? Contact us.