USDM provides standardized methods, processes, and principles to successfully manage your projects, programs and portfolio.

Project and program management are where business, technology, and compliance intersect to achieve desired results. USDM’s project and program management experts help guide, lead, and support your mission-critical project and highly regulated cloud technology implementations.
We offer program management services for all of our engagements to help lead and oversee validation, business, and technical components on your behalf. Additionally, we have staff augmentation solutions for your internal projects that require highly skilled GxP expertise.
We understand that trustworthy project and program management is critical to running successful projects or large-scale programs, and precise execution is imperative to cost containment, sustainability, growth, and profitability.
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. 

Project Management Maturity Model 

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 Senior Program & Project Management Leads complement the vendors’ Technical Project Manager and Solution Architect roles on a validation project for our customers.

USDM’s Value-Based Program Management Approach

USDM’s team leads and oversees validation, business, and technical components on behalf of the customer (in lieu of a customer program manager): 

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

USDM Validation Project Management

Develop all required computer system validation (CSV) documentation: 

  • Draft documents in customer's CSV templates (or provide template if not available)
  • Draft and tailor content with the input of the customer
  • Manage all review and approval cycles
  • Manage and support PQ testing cycles:
  • Draft and dry run PQ scripts
  • Support customer dry run and PQ formal execution
  • Schedule dry run and formal execution kickoff – 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) track management:

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

Portfolio of Case Studies for Life Sciences Project Management 

Thought Leaders

Leading experts in every Life Sciences field.

Learn More
Bob Lucchesi
Bob Lucchesi

Vice President of Global Regulatory Compliance, Quality Assurance and Auditing

Jay Crowley
Jay Crowley

Vice President of Medical Device Solutions and Services

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