• Enterprise Quality Management

Enterprise Quality Management

At the center of your organization's Production, Materials, Facilities, Laboratory and Equipment & Process Control Systems, is your Quality Management System (QMS). FDA's Quality Systems Inspection Techniques (QSIT) model emphasizes the critical importance of the QMS - the one system which is always inspected during either abbreviated or full inspections. Consequently, Life Sciences companies are increasingly taking a holistic view of their QMS rather than the fragmented; silo approach offered by many of the commercially available QMS software packages.

QMS for life sciences companies represents a unique key results area to simplify, unify and optimize compliance investments by replacing 'layers and silos' with a clean and harmonized program.  A well designed QMS has significant financial benefits- not just in compliance savings- but in share price improvement, legal liability avoidance and reduced cost of equity capital.   

Join our upcoming webinar series to learn how you can implement a truly integrated enterprise QMS, become more nimble, make informed decisions through visibility to key business metrics, management dashboards and true quality indicators of enterprise performance and can repurpose headcount from policing functions to innovation.

USDM leverages an experienced delivery team, proven methodologies, and best practices validation documentation to provide our life science customers a rapid, cost-effective approach to implementing, configuring, validating, integrating and supporting your QMS.

Our delivery approach begins with a detailed project plan and proven methodology to drive activities like server sizing and hardware requirements, configuration, training, validation, and data migration. In as little as 4-6 months, USDM can deliver a fully implemented and validated production QMS system.

The combined knowledge of dozens of life science implementations provides us with a great head start on your project. Our skilled quality management experts and business analysts ensure that the final solution is tailored to your specific needs. 

USDM's content expertise includes: Quality Management, Document Management, Records Management, Resource Planning, Manufacturing Planning, Electronic Submissions… and integrating these systems across your company enterprise.

  • QMS Implementation
  • QMS Validation Packages
  • QMS Training – Sys Admin/Workflow/End-User
  • QMS Standard Operating Procedures

USDM supports the following Enterprise Quality Management applications:

  • Sparta Systems TrackWise
  • EtQ Quality Management

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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