Making Change Work: Agile Decision-Making in Highly Regulated Projects
Andrea is a management engineer with four years of experience as a project manager in the design and development of pharmaceutical robotic systems and aseptic processes.
For years now, the world of project management has been evolving—and with it, the PMI standards that help us understand and navigate this changing landscape. Flexibility, adaptability and value-driven delivery are no longer optional; they are core principles of modern project management.
Yet, not all industries evolve at the same pace.
There are sectors where effective and efficient project management is absolutely critical to the success of the final product, but where these modern approaches struggle to take root. These are typically highly regulated environments, or contexts in which even the smallest change must not only be managed, but also carefully assessed, analyzed, documented and remembered.
In such settings, Lean philosophies and agile approaches often face resistance. Sometimes this resistance comes from deep-rooted habits—the classic “we’ve always done it this way” mindset, where any alternative must be proven better before even being considered.
Other times, standard documentation becomes a convenient shield for those who are not truly managing projects, but merely administering them.
There Is No One Right Approach
PMI does not teach us that one approach is right and another is wrong. Instead, it emphasizes tailoring: the ability to select and adapt the most appropriate approach based on the context, objectives, …
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