Commercial-Stage Neuroscience Biopharma Automates Supply Chain, Quality, and Validation

The Challenge

Experiencing rapid growth, the client launched an initiative to streamline and optimize business processes, with automation as a strategic objective. With a new product launch approaching, the company had to be ready to support post-market quality, supply chain, and regulatory activities, and its ERP and eQMS systems had to support growth beyond the initial launch.

Leadership emphasized the importance of validation and wanted a single source of truth for all validation projects, with the ability to automate testing across the enterprise. Internal quality and validation resources were limited.

The Solution

While the system integrator implemented the ERP system, OnShore Technology Group delivered:

• CloudMaster 365^™ for D365: An Enterprise Validation Accelerator for Microsoft Dynamics 365 that reduced document preparation and testing time.
• ValidationPro^℠ Enterprise Validation Delivery Services^™: Qualified validation engineers on demand, SOP and policy development for validation governance, and project management from beginning to end.
• ValidationMaster^® platform: Automated testing and a reusable test script library for D365.
• ValidationMaster eQMS^™: Built on Microsoft SharePoint, delivering controlled document management with automated tracking of CAPAs, nonconformances, complaints, supplier management, audits, and calibration.

Using Microsoft Business Intelligence tools, the client built its own quality and compliance dashboards, and the flexibility of SharePoint lets the team manage and update the system easily.

The Results

• 70% less testing effort: Automating validation with ValidationMaster^® reduced testing time by 70%.
• Automated quality management: ValidationMaster eQMS^™ fully automates the management of key quality processes.
• 21 CFR Part 11: Both systems support 21 CFR Part 11 requirements.
• On time and within budget, with a complete set of validation documentation for compliance.