Agile Validation Support for a Global Life Sciences Organization

Challenge

Scalable support without fixed teams

The client needed a flexible and scalable approach to manage ongoing IT validation tasks. Rather than using traditional project teams or fixed staffing models, they required an on-demand solution to handle routine and ad hoc activities. These included core Computerized System Validation (CSV) tasks such as Installation Qualification, project closure, roll-out support, and the delivery of Periodic Reviews based on criticality and internal planning cycles. A structured yet adaptable model was essential to maintain compliance without adding unnecessary overhead.

Discover our approach

Approach

A task-based validation helpdesk

In October 2022, QbD Group introduced a remote CSV execution service through an outsourcing model designed as a validation “helpdesk.” Instead of project-based workstreams, this model operates via a ticketing system, enabling agile support for individual validation tasks.

To maintain compliance and efficiency, QbD teams use several digital tools, including:

• HP ALM for protocol and test case management
• A Document Control Management (DCM) system for validation document workflows
• Jira and other trackers to assign and monitor tasks
• Systems like SAP to capture evidence during testing

This setup ensures continuous support, full traceability, and alignment with regulated environments.

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Result

Flexibility, speed, and compliance

This on-demand model provided the client with access to highly experienced CSV professionals, allowing for both execution support and process improvement. The scalable structure helps them adjust resources based on actual workload—avoiding the cost and complexity of full-time hires.

By delegating validation execution and recruitment to QbD Group, the client gained:

• Quick turnaround times
• Cost savings on hiring, onboarding, and benefits
• Access to specialized validation talent
• A streamlined and compliant validation process

This partnership enables the client to stay focused on their core business, while QbD ensures operational agility and quality in their IT validation processes.

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