Human-centered governance: how people make the difference in regulated projects.

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In highly regulated organizations, it is common to believe that detailed planning and flawless documentation are enough to guarantee a project’s success. But the reality in the field is often different. Even though having a structured PMO and complying with formal governance frameworks is essential, everything starts to fall apart when the human factor is overlooked.

Regulations such as PCI-DSS (Payment Card Industry Data Security Standard), FDA standards FDA tax regulations cybersecurity requirements or traceability systems impose a high level of control and formalism. This creates a strong dependence on documented processes, strict validations, and written records. Without realizing it, projects risk becoming bureaucratic exercises… and losing their soul.

Because at the end of the day, projects are not executed on documents—they are executed by people. They are the ones who solve problems, adapt, communicate, face resistance, and find ways to move forward. If their expectations, emotions, and capabilities are not managed, compliance becomes just a façade, and the real impact is put at risk.

During a consulting engagement with a client in the services sector, we witnessed a case that clearly illustrates this disconnect. Although there was an active PMO and the governance structure was well defined, the project began to deteriorate from the very beginning. The selected vendor did not meet the expected standards—something that was evident from the first conversations. However, the decision was maintained, creating a gap between senior management and the operational team. This lack of alignment undermined the project’s credibility, and as a result, no one truly wanted to take ownership of its execution. The warnings were raised on time and the vendor was eventually cancelled, but recovering the project required time and resources that could have been avoided.

This experience left us with a powerful lesson: governance does not live in forms, but in the people who believe in the project’s purpose. Structure is necessary, yes, but without a shared vision, credible leadership, and a sense of ownership, regulated projects —no matter how many checklists they have— run the risk of failing.

Per Mirtha Cabrera
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