Critical Care Medical Device Manufacturer Standardizes Enterprise Validation

The Challenge

The company needed an enterprise validation management program for its process, equipment, lab, and computer systems validation projects. It used more than 50 enterprise applications with different software release cadences and was managing validation on paper.

Document cycle times were long, which delayed the adoption of new technologies. As the company expanded, it had no high-level view of its enterprise program to support decision-making, and it spent significant time writing and re-writing test scripts for large enterprise technologies.

The Solution

The client selected ValidationMaster^® for its flexibility, multi-language support, dashboards, and out-of-the-box interoperability with more than 40 applications. OnShore Technology Group delivered:

• A Qualification Pak: All documentation required to validate the system prior to first use.
• Training: In-person training plus access to ValidationMaster^® Academy online.
• A secure, integrated deployment: ValidationMaster^® was implemented with Azure AD single sign-on, then integrated with the client’s DevOps environment and ServiceNow instance.
• Client templates: The client’s validation templates were loaded into ValidationMaster^® so every document publishes in its required format.

The Results

• Enterprise visibility: Customizable dashboards and a project portfolio view show every validation project across the enterprise.
• Paper processes eliminated: Automated document generation and a reusable test script library replaced manual work.
• 60% reduction in testing time through the reusable test script library.
• Global delivery: The solution was delivered in the language of each supported company location, on time and within budget.