Your agile project team is developing a medical device software component that requires FDA regulatory approval. You're using two-week sprints with a definition of done that includes unit tests, integration tests, and code review. The regulatory affairs department insists that no code can be released to production without completing a validation protocol that takes 6-8 weeks and costs $50,000 per validation cycle. Marketing is pressuring for faster feature delivery to respond to competitive threats. The team is frustrated because completed increments sit unreleased for months. How should you adapt your agile approach to balance regulatory compliance with agile principles?

Question

Accepted Answer

The correct answer is D. Option D is correct because it addresses the constraint while preserving agile values by transforming the regulatory process itself (ECO Process Task 14.3 - Adapt methodology for project constraints). Modern regulatory frameworks increasingly support continuous validation and risk-based approaches. This enables faster feedback cycles while maintaining compliance, truly solving the business problem rather than accepting a suboptimal compromise. Option B appears to maintain agile practices but actually accepts the 'potentially shippable' fiction—code that can't ship for months isn't truly shippable, and this approach doesn't solve the competitive pressure issue. Option A creates waste through hardening sprints, which indicates the definition of done is incomplete. Option C is essentially waterfall with agile terminology and loses the benefits of both approaches.

PMP Practice Question: Process — Agile, Hard

More Process Questions