Skip to content

Current Press

OnShore Technology Group Secures Expanded Enterprise Validation Engagement with Major Vaccine Manufacturer

April 22, 2025 · 3 min read

16-year partnership leads to enterprise-wide deployment of ValidationMaster® and CloudMaster 365™ to support Microsoft Dynamics 365 ERP and over 26 critical system integrations.


April 22, 2025

CHICAGO, IL — OnShore Technology Group, a leading provider of enterprise digital validation software and Independent Verification and Validation (IV&V) professional services for life sciences, is pleased to announce the expansion of its long-standing relationship with a major global vaccine manufacturer, a client of OnShore for over 16 years. The company has selected OnShore’s award-winning platforms, ValidationMaster® and CloudMaster 365™, for enterprise-wide deployment to support the validation of its Microsoft Dynamics 365 for Finance and Operations (F&O) ERP system and more than 26 integrated business-critical systems.

This new engagement highlights OnShore’s expertise in delivering complex, large-scale validation solutions for highly regulated environments, including the life sciences and vaccine manufacturing sectors.

“We are proud to continue our longstanding partnership with this world-class vaccine manufacturer and to support their global digital transformation through ValidationMaster and CloudMaster 365,” said Valarie King-Bailey, CEO of OnShore Technology Group. “Validation is more than compliance—it’s about ensuring quality, integrity, and operational excellence at every stage of the manufacturing and supply chain process. We are honored to help this client meet their ambitious goals with the confidence of a validated, compliant enterprise solution.”

Enterprise-Wide Digital Validation for Microsoft Dynamics 365 and Complex Integrations

The vaccine manufacturer is utilizing ValidationMaster® as its enterprise-wide Digital Validation Management System (eDVMS) to standardize validation practices for:

  • Computer Systems Validation (CSV)
  • Process Validation
  • Equipment Commissioning and Qualification (C&Q)
  • Compliance Documentation and Audit Management

To support the validation of its Microsoft Dynamics 365 for Finance and Operations ERP system, the company is leveraging CloudMaster 365™, OnShore’s robust Validation Accelerator that delivers:

  • Pre-configured validation planning documents and templates.
  • Automated test execution and reporting powered by TestMaster AI.
  • Accelerated validation timelines and reduced compliance risks.

The client’s D365 environment includes over 26 critical system integrations, such as:

  • L7 Laboratory Information Management System (LIMS)
  • Oracle Eloqua for marketing automation
  • CDC IRR Reporting
  • Sam.gov contract reporting
  • UltiPro HR and payroll management
  • Carrier Management Systems
  • Optical Character Recognition (OCR) automation

The system also encompasses more than 41 separate customizations, each requiring rigorous validation in compliance with FDA 21 CFR Part 11, Annex 11, GAMP 5, and other applicable regulatory standards.

Supporting Global Vaccine Manufacturing Excellence

Through this enterprise-wide expansion, the client will achieve

  • Standardized, risk-based validation processes across global operations.
  • Enhanced regulatory compliance with built-in audit trails, electronic signatures, and validation automation.
  • Increased operational efficiency by leveraging OnShore’s digital validation solutions to accelerate system implementation while reducing manual effort.

About OnShore Technology Group

OnShore Technology Group is a global provider of enterprise digital validation software and IV&V professional services exclusively serving the pharmaceutical, biotechnology, medical device, and regulated manufacturing industries. Its award-winning platforms—ValidationMaster®, TestMaster AI, and CloudMaster 365™—help organizations automate, manage, and optimize validation processes while ensuring compliance with global regulatory requirements.

For more information, visit: www.validationmaster.com

Share

Stay Connected with Validation365™

Stay informed with the latest company news, industry insights, executive commentary, and research.