Managing Projects in a Regulated Environment

In most projects, the primary stakeholder is the sponsor. For projects in regulated environments, the regulator becomes an equal, maybe even the primary stakeholder. Here are six actions to consider when your project runs in a regulated world. 

• Make sure you completely understand relevant regulations. Regulatory compliance is a deliverable! To successfully deliver that compliance, the PM and team members need to grasp all aspects of the regulations and what is needed to satisfy them. This understanding helps when talking with key stakeholders and senior leaders, too. Their confidence in the project increases when you’re able to describe the regulations clearly and accurately and what needs to be done to address them.
• Understand the difference between regulated output and regulated processes. Make sure you know what you can and cannot change. Some regulations address the required output and the processes used to create that output, such as with new drug development and testing. In other cases, accurate reporting is regulated, but the processes to generate those reports aren’t. People in regulated environments often assume that the processes to produce regulated output are also regulated. As a result, they might overlook valid and efficient process changes. 
• Designate a compliance owner(s). Choose a team member to coordinate the interpretation of regulations, track organizational obligations, and monitor compliance-related risks. A business process and legal expert is typically the best person for this role. For larger projects, consider appointing more than one owner. If you have more than one, make sure the responsibilities of each owner are clear so you don’t create overlaps or gaps in compliance monitoring.
• Treat testing as mandatory. Testing is often reduced to decrease duration when the project schedule is tight. However, in regulatory projects, the deliverables need to demonstrate control, traceability, and conformity. Thorough testing is the only way to do this. Reduced testing in these projects is high-risk.
• Assume a regulator will audit your records. Keep thorough and detailed project records throughout the project lifecycle. Those records could become evidence in an audit to confirm regulatory compliance. Solid project records are fundamental to demonstrating control, which auditors will use to identify how your project and organization plan to comply with the regulations.
• Consider regulator assistance if feasible (they are a stakeholder)! One way to ensure that regulations are understood and followed is to involve regulators throughout the project. They can review solutions, propose test scenarios, and examine processes and data stores to ensure compliance in advance. This can save time and money and promote goodwill with regulators.

Coming Up

I’m starting to work on updating a couple of my projects. Stay tuned for more info!

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