By: Simone Bernardi, Anders Ekman, Celeris AB
More than a century ago Charles Darwin recognized that:
It is not the strongest or the most intelligent who will survive but those who can best manage change. (Charles Darwin)
This holds true for companies as well, especially those days where their product and governance is exposed to a set of increasing and constantly evolving regulations and requirements. Hundreds of regulatory updates get namely issued as of every day worldwide. This happens in form of new regulations, new versions of the same, regulatory updates, new regulatory interpretations, local adaptations, letters from industry associations and so on and so forth… As a regulatory expert or a requirements manager within a company you most probably already experienced the time when a regulatory compliance project converges slowly to an end and there it is, another one needs already to be set up as a new regulatory wave is already materializing at the horizon.
Requirements gets identified, tagged, traced and versioned… still they need to be managed as they can evolve and change over time. The ability to manage change efficiently and effectively can be an important discriminant between top and poor performers in your industry. The continuously succession of regulatory waves is also one of the determinants which is moving companies to realize that regulatory compliance is a continuous rather than a one-off game to play.
Big and inefficiently regulatory compliance projects are often substituted by micro teams, product aligned, which take front to back accountability of the products’ management, inclusive its regulatory compliance, on an ongoing basis. Teams are often hierarchically organized following SAFe-inspired frameworks, see for example Beerbaum (2021) for a comparison of scaled agile frameworks within global organizations that deliver regulatory projects. This environment of (potentially hundreds of teams) goes arm in arm with an investment in professional requirements engineering software. New or updated regulatory requirements need to feed the organization’s internal regulatory ecosystem in an organic manner and reach the right teams at the right moment in time.
References: Beerbaum (2021)RegSafe© manifesto - an agile management control methodology for regulatory - driven programs.Source: Seven steps toward regulatory excellence – Step 5 – Requirements Change Management | LinkedIn

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