USDM understands that trustworthy, experienced resources are critical to running successful projects or large-scale programs.
The short version: When you run IT for a regulated life sciences organization, you are the de facto program manager for every project on your plate. USDM's GxP-experienced project and program managers lead and support your mission-critical projects and highly regulated cloud technology implementations, overseeing validation, business, and technical work on your behalf. The result is a standardized, repeatable methodology that keeps complex programs on time, on budget, and audit-ready.
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. That same depth of expertise extends to modern, risk-based approaches such as Computer Software Assurance (CSA) and continuous validation through validation lifecycle management.
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.
Why the methodology matters: 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 and defined processes that are standardized, quantified, and optimized for repeatable results.
Project and program management are where business, technology, and compliance intersect to achieve desired 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
What GxP Program Management Covers
USDM's regulated program management spans three connected disciplines that most IT leaders are forced to juggle alone:
- Validation leadership — computer system validation documentation, PQ testing cycles, deviations, and closeout, all tailored to your templates and standards.
- Business oversight — stakeholder coordination, workflow and business analysis, status reporting, and issue resolution with vendors and providers.
- Technical delivery — configuration management, environment deployment, administration training, and post-production support across your cloud technology stack.
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)
As regulated programs increasingly span AI-enabled tooling and autonomous workflows, USDM brings the same disciplined approach to emerging technology — pairing program leadership with AI governance and compliance and the specialists on USDM's agentic AI team so innovation moves forward without compromising your GxP posture.
FAQ: GxP Program and Project Management
What does a GxP program manager actually do?
A USDM GxP program manager leads and oversees the validation, business, and technical components of your project in lieu of an in-house program manager. That includes managing scope, schedule, cost, and risk; leading stakeholder involvement; overseeing the vendor's technical PM, testing, and configuration; coordinating validation team timelines; running weekly status meetings; and delivering weekly status reports.
How is USDM's project management methodology different?
USDM's approach is built on a patented Project Management Maturity Model based on Project Management Institute (PMI) strategy. It relies on defined processes that are standardized, quantified, and optimized for repeatable results, led by subject matter experts with decades of hands-on experience overseeing complex programs of all sizes.
Can USDM supplement my existing team instead of replacing it?
Yes. USDM's staff augmentation solutions provide highly skilled GxP expertise exactly where you need it. Senior-level program and project management leads complement your technical project managers and seasoned solution architects on validation projects.
What validation deliverables does USDM produce?
USDM develops all required computer system validation (CSV) documentation — drafting in your templates (or providing them), managing review and approval cycles, supporting PQ testing cycles, scheduling dry run and formal execution kickoffs, ensuring testers are trained on GxP, tracking issues, and supporting deviations and PQ closeout activities.
Does USDM support cloud technology implementations?
Yes. USDM provides cloud vendor technical project management and solution architecture — including project planning, application configuration, administration training, QA and production environment deployment, and post-production technical support.
Lead Your Next Regulated Program with Confidence
Whether you need a program manager to run a mission-critical validation effort or seasoned GxP expertise to augment your team, USDM brings proven methodology and decades of life sciences experience to keep your projects on time, on budget, and compliant.
Contact USDM to discuss your GxP program or project management needs.