Agile validation in GxP based on GAMP 5

By combining the flexibility of Agile methodologies with the stringent requirements of GxP, Agile validation ensures the development of high-quality, compliant software solutions, meeting both user needs and regulatory standards in highly regulated industries.

The goal of the course

• Explore how GxP-regulated companies can leverage Agile validation within their validation processes

• Understand how software vendors can develop software tailored for GxP-regulated industries

• Learn how pharmaceutical companies can utilize agile validation to develop and validate software for their internal use

Scope of the course

• Introduction

• Concepts, definitions & regulations

• Agile basics based on Scrum

• Mapping V Waterfall (GAMP5) and Agile (Scrum) models

• User Stories, Invest, Definition of Ready & Definition of Done for User Story

• Testing in Agile Validation GxP

• Definition of Done for sprint and product, Continuous Validation, Validation Plan & Report

Agile validation in the context of GxP (Good x Practice) standards refers to the application of Agile methodologies to ensure compliance with regulatory requirements in industries such as pharmaceuticals, healthcare, and other highly regulated sectors. Unlike traditional waterfall methods, Agile validation in GxP environments emphasizes flexibility, collaboration, and iterative development while maintaining the necessary documentation and validation processes to meet regulatory standards

Here are key aspects of Agile validation in GxP:

1. Iterative Development: Agile validation allows for iterative development, where software functionalities are developed and tested incrementally. This approach enables continuous feedback and adjustments, ensuring that the final product aligns with user requirements and GxP regulations.

2. User Involvement: Agile emphasizes the active involvement of end-users and stakeholders throughout the development process. In the context of GxP, this involvement is crucial for understanding user requirements, and validation needs, and ensuring that the software meets compliance standards.

3. Documentation and Traceability: While Agile promotes minimal documentation, in GxP environments, certain documentation is mandatory for compliance. Agile validation strikes a balance by maintaining essential documentation, such as user stories, acceptance criteria, and test cases, while avoiding unnecessary bureaucracy, and ensuring traceability and auditability.

4. Compliance-focused User Stories: User Stories in Agile are enhanced to include compliance-related requirements. Each User Story is crafted with GxP standards in mind, specifying necessary compliance criteria, validation protocols, and quality assurance processes.

5. Cross-functional Collaboration: Agile validation encourages collaboration among cross-functional teams, including developers, testers, quality assurance professionals, and regulatory experts. This interdisciplinary collaboration ensures a holistic approach to GxP compliance, incorporating technical aspects, validation needs, and regulatory guidelines.

6. Continuous Validation: Unlike traditional validation processes, Agile validation is continuous and integrated into the development cycle. Validation activities are performed iteratively, allowing teams to identify and address compliance issues early in the development process, reducing the risk of non-compliance in the final product.

7. Adaptability to Change: Agile methodologies, with their focus on adaptability and responsiveness to change, allow GxP-compliant projects to accommodate evolving regulatory requirements. Teams can quickly adjust their processes and validation strategies to align with updated standards and guidelines.