---
title: "From V-model to Agile: How to Embrace Automation as Part of the Computerized System Validation Approach"
description: "Computerized System Validation doesn't have to stand in the way of Agile software development. Discover how to combine Agile flexibility with the assurance and control regulated systems demand."
url: https://qbdgroup.com/en/whitepapers/from-v-model-to-agile
type: "White paper"
language: en
published: 2024-09-16
publisher: "QbD Group"
citation: "QbD Group, \"From V-model to Agile: How to Embrace Automation as Part of the Computerized System Validation Approach\", https://qbdgroup.com/en/whitepapers/from-v-model-to-agile"
---
# From V-model to Agile: How to Embrace Automation as Part of the Computerized System Validation Approach
> Computerized System Validation doesn't have to stand in the way of Agile software development. Discover how to combine Agile flexibility with the assurance and control regulated systems demand.

Computerized System Validation doesn't have to stand in the way of Agile software development. But bringing Scrum into a GxP-regulated environment requires a different approach to validation, testing and documentation. Discover how to combine Agile flexibility with the assurance and control regulated systems demand.

## About This White Paper

Agile development has become increasingly important in software development, including in regulated life sciences. **GAMP 5 supports the use of Agile methodologies**, but moving away from the traditional V-model raises an important question: how do you maintain a compliant Computerized System Validation (CSV) approach when software is developed iteratively?

This white paper takes you from the fundamentals of Agile and Scrum to their **practical application in a GxP environment**. It explores how requirements, testing, documentation and validation activities can be adapted to shorter, iterative development cycles without losing sight of quality and regulatory expectations.

It also looks at the **role of automation** and presents practical ways to bridge the gap between Scrum and traditional validation approaches, helping teams benefit from Agile development while maintaining the level of assurance expected in life sciences.

## Key Takeaways

- **Understand the shift from V-model to Agile.** See how software development evolved from sequential models towards iterative approaches, and what this means for computerized system validation.
- **Bring Scrum into a GxP environment.** Learn how Scrum concepts such as sprints, product backlogs, user stories and definitions of done can be applied while accounting for validation and regulatory requirements.
- **Adapt your CSV approach to Agile development.** Explore how GAMP 5 activities can be mapped to an Agile way of working and where traditional validation practices need to evolve.
- **Address the testing challenges Agile introduces.** Understand where unit, system, integration and acceptance testing fit within Scrum, and why some validation activities are difficult to accommodate within individual sprints.
- **Use automation to support faster validation cycles.** Discover how automated testing and techniques such as design for testing, smoke tests, regression testing and unit testing coverage can help validation keep pace with iterative development.
- **Find the right balance between flexibility and assurance.** Learn how Agile development can be combined with the structure needed for quality and compliance, rather than treating Agile and traditional validation as opposing approaches.
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Source: https://qbdgroup.com/en/whitepapers/from-v-model-to-agile — © QbD Group. Quote freely with attribution and a link back.