USDM CRM Services

The USDM’s CRM practice focuses on helping life science companies select, implement and selectively validate CRM systems and platforms for GxP environments based on a pragmatic risk based approach. We bring value to our clients through the combination of our deep knowledge of CRM and GxP processes and our industry experience in system implementation and validation.

Services include:

  • Compliance and risk assessment of CRM applications and processes
  • Development of validation strategy and quality plans for CRM
  • Validation of CRM software packages and their integration with internal/external systems
  • Development of outsourced CRM compliance strategy
  • Performance of on-site vendor audits covering key IT GAMP 5/Part 11 requirements for platform and application management
  • Developing detailed Service Level Agreements with CRM SaaS suppliers
  • Helping execute formal Quality Agreements with CRM SaaS suppliers
  • Providing qualification packages for multi-tenant/VM platforms, interfaces
  • Verifying CRM system and data recovery processes, DR qualification

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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