---
title: "Agile Validation Support for a Global Life Sciences Organization"
description: "Discover agile validation support for life sciences, enhancing compliance and efficiency through a scalable, on-demand model tailored to your IT validation needs."
url: https://qbdgroup.com/en/case-studies/agile-validation-support-for-a-global-life-sciences-organization
type: "Case study"
language: en
published: 2025-08-06
publisher: "QbD Group"
citation: "QbD Group, \"Agile Validation Support for a Global Life Sciences Organization\", https://qbdgroup.com/en/case-studies/agile-validation-support-for-a-global-life-sciences-organization"
---
# Agile Validation Support for a Global Life Sciences Organization
> Discover agile validation support for life sciences, enhancing compliance and efficiency through a scalable, on-demand model tailored to your IT validation needs.

A **leading global healthcare company** specializing in **regulated medicinal products** relies on a **centralized validation team** at its headquarters in **Southern Europe**. This team supports **over 60 affiliates worldwide**, each operating with at least one **GxP-regulated IT application** or managing **GxP-related data**. Centralizing these validation activities allows for greater consistency, traceability, and compliance across the group.

## 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](https://qbdgroup.com/en/case-studies/agile-validation-support-for-a-global-life-sciences-organization#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**.

[Read more about the results](https://qbdgroup.com/en/case-studies/agile-validation-support-for-a-global-life-sciences-organization#results)

## Results

## 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.

[Also need support?](https://qbdgroup.com/en/case-studies/agile-validation-support-for-a-global-life-sciences-organization)
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Source: https://qbdgroup.com/en/case-studies/agile-validation-support-for-a-global-life-sciences-organization — © QbD Group. Quote freely with attribution and a link back.