• Digital Transformation

  • careers

  • Internet of Medical Things Banner Home

  • careers

USDM Life Sciences

Life Sciences Accelerated! We are a global firm with more than 20 years of experience offering bold solutions that accelerate innovation and compliance in the life science industry. Our ability to explore and utilize the latest trends in technology while charting a map for our customers to remain compliant is a key differentiator in this heavily regulated industry.

We are ex-FDA regulation gurus and techno-geeks who combine to form innovative teams that transform how life science firms operate. Our philosophy is proactivity, simplicity, standardization, process excellence, and reusability.

 
Choose your path. Connect with us, talk to us, learn how we live and breathe “Life Sciences Accelerated!”

Validation Package for NextDocs

Enterprise Content Management systems provide a platform for creating, editing and managing critical business documents for an organization. Knowing where documents are, controlling access to them, finding them quickly, linking them to business processes, and archiving or destroying them at the right time in their lifecycle are fundamental requirements for regulated industry.

NextDocs and USDM have partnered to provide a comprehensive solution to support Life Sciences companies in egulatory requirements for the NextDocs ECM system. 

Our Validation Accelerator Package (VAP) provides validation assistance with core regulatory requirements for the following modules:

  • Document Management System
  • Quality Management System
  • Regulatory Document Module
  • Clinical Document Module
  • SOP Management Module

USDM's NextDocs ECM VAP documentation provides a pre-configured content rich set of templates, ready for customization to meet both domestic and international regulations. Our documentation templates include:

  • Validation Plan
  • User Requirements Template
  • Risk Assessment
  • Functional and Design Specification
  • Installation Qualification
  • Operational Qualification
  • Performance Qualification Template
  • Trace Matrix
  • Validation Summary Report

USDM works closely with NextDocs to identify upcoming patches and updates, and provides a full maintenance program for our NextDocs ECM clients. Recommendations for required testing are made to ensure our clients an effective, efficient validation maintenance process.

USDM has a dedicated, experienced ECM validation team that can customize the VAP templates and provide best practice consulting on regulatory compliance.

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…
See all Testimonials