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Project Management: Rules of Engagement

Adapting Computer System Validation to Accommodate Evolving FDA Guidance

Establishing rules for accountability and responsibility are critical to a project management team’s success.

When team members come together for a project, they are bringing with them a variety of skills, experiences, preferences, and behaviors. In the world of project management, establishing the team’s rules of engagement will set the tone for courtesy and respect. It typically starts with an operating agreement that includes guidelines for decision-making, meeting management, accountability and responsibility, conflict resolution, and the role of the leader. Another important aspect of a project management team is communication and engagement.

During the project kick-off meeting, the team should agree on forms of communication. For example, will it be through email only or will it include instant messaging? What about text messages? Consider what is best for the team and establish your rules for communication.

Project Management and Working Remotely

Accommodating remote workers happened quickly in 2020 and whether or not you were ready for it, the entire concept has taken hold. Still, it is possible to manage virtual workforces in regulated environments while maintaining business continuity and continuous compliance.

Rules of engagement for working remotely include defining clear goals and expectations for your teams. Because communication will be online, be sure that your emails and instant messages are specific about project objectives, goals, and expectations.

You also need to provide frequent feedback. If working remotely is new to any of your team members, it may take them a while to adjust to the circumstances. They might be stuck at one extreme or the other: working too many hours because it’s easy to check messages, or getting distracted by social media and streaming binge-worthy shows “for background noise.” Keeping your employees accountable and establishing the rules of engagement for doing so are critical to everyone’s success.

Here are five essential aspects to effectively managing any project on-site or virtually:

  1. Ensure that you have executive approval and support.
  2. Establish scope, timelines, and budget for the project.
  3. Ensure that you have the right people with the right skills on your team.
  4. Create clear expectations and “ways of working,” and continuously monitor and communicate these expectations.
  5. Build a culture of accountability and trust.
    1. Define clear roles and responsibilities.
    2. Define clear metrics for success.
    3. Allow for some flexibility in your team’s schedules.
    4. Lead by example.

How USDM Can Help

For more than 20 years, USDM Life Sciences has helped customers effectively manage and execute their compliance and IT projects. This tightly managed approach led by a virtual project management office ensures that a virtual team can meet your project deadlines on time with transparency and compliance. Using our flexible managed staffing solution, you can assign a new team or manage an existing team, while USDM handles the overhead and supervision of the team. A dedicated team lead handles the members’ needs, issues, and concerns while you maintain business continuity and focus on strategic priorities.

USDM’s Project and Program Management Services and Solutions experts are the perfect fit to help guide, lead, and support life sciences organizations’ mission-critical project and program initiatives across highly regulated areas—where compliance, technology and business intersect—to attain desired business results. USDM can provide the services needed to successfully manage your projects, your programs, and your portfolio with consistent and standardized methods, processes, and principles.


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