GxP Expertise for Program and Project Management

USDM understands that trustworthy, experienced resources are critical to running successful projects or large-scale programs.

When you’re leading the IT organization for your company, you typically have several projects going on simultaneously. You’re the defacto program manager because you oversee all the projects, even when they have individual project managers. You manage stakeholders, deal with vendors, coordinate resources, and make sure all the tasks get done. Timelines, budgets, deliverables, and people fall within your purview.

Project and program management are where business, technology, and compliance intersect to achieve desired results. Are you where you want to be? Are your teams able to practice innovative thinking? Does program and project management consume more of your time than you’d like?

USDM understands that trustworthy resources are critical to running successful projects or large-scale programs, and precise execution is imperative to cost containment, sustainability, growth, and profitability. Our standardized methods, processes, and principles can help you manage your projects, programs, and portfolio.

How USDM Can Help

USDM’s project and program management experts help lead and support your mission-critical projects and highly regulated cloud technology implementations. We can oversee validation, business, and technical components on your behalf.

Our staff augmentation solutions also provide you with highly skilled GxP expertise where you need it. We have the senior-level program and project management leads to complement technical project managers and seasoned solution architects on validation projects.

USDM has an on-time and on-budget delivery rate 35% higher than the industry average because our proven project management methodology is led by subject matter experts with decades of hands-on experience overseeing complex programs of all sizes.

Our Project Management Maturity Model is based on the Project Management Institute (PMI) strategy to achieve goals. This patented model ensures success through industry best practices based and defined processes that are standardized, quantified, and optimized for repeatable results.

USDM’s Value-Based Program Management Approach

The USDM team leads and oversees validation, business, and technical components on your behalf (in lieu of an in-house program manager), including:

• Manage project scope, schedule, cost, and risk
• Manage overall budget
• Lead stakeholder involvement
• Oversee the vendor’s technical PM, testing, and configuration
• Coordinate validation team timelines and manage overall project plan
• Provide business analysis support for workflow development
• Lead weekly status meetings
• Facilitate business discussions and issue resolution with providers
• Provide weekly status reports

USDM Validation Project Management 

Develop all required computer system validation (CSV) documentation:

• Draft documents in your CSV templates (or provide templates if not available)
• Draft and tailor content with your input
• Manage review and approval cycles
• Manage and support performance qualification (PQ) testing cycles for the draft and dry run PQ scripts
• Schedule dry run and formal execution kickoff, and ensure testers are trained on GxP
• Issue tracking and vendor escalation (as needed)
• Support deviations and PQ closeout activities (as needed)
• Provide IT, QA, and SME support

Cloud Vendor Technical Project Manager and Solution Architect

Technical (configuration) management:

• Project plan and timelines
• Configuration of application
• Administration training
• Deploy QA and production (PROD) environments
• Managed services/post PROD technical support (does not include change management for new releases)

Contact USDM to discuss your GxP program or project management needs.