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Accelerating Compliance for Better Business Outcomes


Learn how USDM’s Compliance-as-a-Service model transformed the compliance program of a Fortune 1000 medical device company needing a compliance strategy overhaul.

USDM deployed a Compliance-as-a-Service program and restructured numerous GxP processes to achieve corporate-wide validation consistency while reducing validation timelines and overall costs.

The Situation
  • Fortune 1000 medical device manufacturer with 15k products globally
  • Compliance activities had grown significantly
  • No corporate standard for validation
  • CSV methodology mistakenly being applied to product validation
  • Too many compliance vendors with no ownership
  • Inconsistent documentation approach with many gaps in compliance requirements
  • Recent offshore outsourcing of change control and change control traceability was inadequate
  • Quality leadership wanted holistic, corporate–wide visibility of the status of compliance
The Solution

Deployed USDM’s Compliance-as-a-Service program with the following key activites:

  • Set up new corporate-wide governance program
  • Assembled business, quality, technical owners to drive alignment
  • USDM took ownership of all quality functions:
    • Infrastructure Maintenance / Performance
    • Systems Development and CSV Projects
    • SOP and Process Improvements
    • Data Integrity / Security
    • Systems Upgrades / De-commissions
    • Site based QA / CSV
    • Data Center and Site Remediation
  • Scheduled weekly, monthly and quarterly meetings with various stakeholders. Monthly and quarterly include VP and C levels.
  • Scope of the work included:
    • Rolled out Compliance as a Service that would centralize all compliance activities and oversight
    • Initiation – The program involved a Quality System process improvement workstream as part of the initiation phase with the following activities:
      • Assess current systems for gaps
      • Defined corporate standard for validation and enterprise systems, manufacturing, and infrastructure
      • Implemented ITIL methodology for change control.
      • Organizational Change Management drove standards down to division and site levels
  • ​Ongoing Operations – USDM provides weekly, monthly and quarterly metrics to stakeholders in a variety of meetings

The Results

Large ERP project effort reduced:

  • 50% fewer resources required
  • 50% faster delivery 
  • Delivered 60% more functionality once reaching steady state


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