• IT / Virtualization

 
 
 

IT Compliance and Computer Systems Validation Services

USDM Supports its clients with compliance and validation solutions that are risk-based and appropriately scaled to meet your unique business and regulatory requirements.

Our subject matter experts are some of the industry's most accomplished and brightest practitioners. They are well versed in business process, international regulatory compliance, and Information Technology. Our approach is both consultative and pragmatic in compliance interpretation and application.  Underpinning these values are current industry and regulatory best practice – such as GAMP, ASTM 2500 ICH Q9 and ISO quality standards.

Our IT compliance service offerings include:

  • Internal Audits and External Data Center Audits
  • Software Vendor Audits / Vendor Assessments
  • Procedures / Programs and Training for the following:
    • Network Infrastructure Qualification
    • Change Control
    • Validation Methodologies
    • CAPA (Corrective Action Preventative Action)
    • 21 CFR Part 11
    • Operations
    • Inventory
    • Procurement / Standardization
    • Retirement
    • Installation
    • Data Management
    • Configuration Management
    • Security
    • Maintenance
  • Computer Systems Validation (CSV)

Testimonials

  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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