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 Life Sciences understands that this critical work is the driving force to advance our customers. Our project and program management experts help guide, lead, and support your mission-critical project and program initiatives across highly regulated areas.

With a project on-time and on-budget delivery rate 35% higher than the industry average, our proven project management methodology is led by subject matter experts with decades of hands-on experience overseeing complex programs of all sizes. 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.
 
Our Project Management Maturity Model is based on the Project Management Institute (PMI) strategy to achieve goals.This patented model ensures success through the deployment of industry best practices based on defined processes that are standardized, quantified, and optimized to ensure consistent, repeatable results rather than individual heroics.
 
Below is a sample of responsibilities for USDM’s Senior Program & Project Management Leads and how this complements the vendor’s Technical Project Manager and Solution Architect roles on a validation project for our Emerging/Startup customers.

USDM Program Management
Lead and oversee validation, business, and technical components on behalf of the customer (in lieu of 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)

Case Study References:

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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