A risk-based approach is a cornerstone of modern GxP validation approaches. It focuses resources where they matter most, ensuring patient safety and product quality while optimizing efficiency.

GAMP 5 (Good Automated Manufacturing Practice) is a widely recognized framework for the validation of computerized systems in the pharmaceutical and life sciences industries. It provides a risk-based approach to validation, emphasizing a structured, risk-based approach to validation, covering the entire system lifecycle, from initial concept and design to retirement. As IT organizations mature and rely increasingly on Agile methodologies, GAMP 5 principles can be applied – even thought they seem to represent different approaches at first glance.

By combining the best practices of GAMP 5 and Agile, organizations can develop and validate high-quality software that meets regulatory requirements and delivers value to users in a timely and efficient manner.

Here’s how GAMP 5 can be applied within an Agile framework:

 

1.  Risk-Based Approach:

  • GAMP 5’s core principle of risk assessment aligns well with Agile’s iterative nature.
  • Risks are identified and evaluated at the beginning of each sprint (short development cycle), allowing teams to prioritize validation activities and focus on critical areas.
  • Risks can be reassessed and validation efforts adjusted as the project progresses and new information emerges.

2.  Continuous Validation:

  • Agile’s iterative approach enables continuous validation, which is also a key concept in GAMP 5.
  • Instead of validating the entire system at the end, validation activities are integrated into each sprint, ensuring that newly developed features are tested and verified early and often.
  • This allows for early detection and resolution of defects, reducing the risk of costly rework later in the project.

3.  Flexible Documentation:

  • While GAMP 5 emphasizes comprehensive documentation, it doesn’t mandate a specific format.
  • Agile teams can leverage this flexibility by using lightweight documentation that focuses on essential information and can be easily updated as the project evolves.
  • This avoids creating unnecessary documentation burden while still ensuring regulatory compliance.

4.  Collaboration and Communication:

  • Both GAMP 5 and Agile stress the importance of collaboration between different stakeholders, including developers, testers, quality assurance personnel, and business users.
  • Regular communication and feedback loops ensure that validation requirements are clearly understood and integrated into the development process.
  • This collaborative approach helps to identify and address potential risks early on, improving the overall quality of the software.

5.  Adapting Validation Activities:

  • Traditional validation activities like Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) can be adapted to fit the Agile framework.
  • IQ and OQ activities can be performed early in the project to ensure that the development environment and basic functionalities are validated.
  • PQ activities can be integrated into each sprint to test and verify new features as they are developed.

 

By integrating GAMP 5 principles into Agile development, organizations can achieve multiple benefits, such as:

  • Faster time to market: Continuous validation allows for quicker identification and resolution of issues, reducing the overall development time.
  • Improved software quality: Early and frequent testing ensures that defects are caught early, leading to higher quality software.
  • Reduced risk: Risk assessment and continuous validation help to minimize the risk of system failures and regulatory non-compliance.
  • Increased efficiency: Flexible documentation and streamlined validation processes improve efficiency and reduce costs.

 

Want to learn more about GAMP5?

The primary reference for GAMP 5 is the official guidance document published by the International Society for Pharmaceutical Engineering (ISPE):

  • ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition): This is the most comprehensive and up-to-date resource on GAMP 5, providing detailed guidance on the principles, methodologies, and best practices for implementing a risk-based approach to computerized system validation. It covers the entire system lifecycle and addresses various aspects of validation, including risk assessment, category classification, validation planning, execution, and documentation.

 

This guide is available on the ISPE website: