We cannot deny that we live in a world focused on change and transformation. All the technologies and used systems are evolving and go a few steps forward. GAMP 5 also kept pace with the development and met us with its official 2nd edition after 14 years from its first edition. Of course, key concepts, as well as ICH Q9 based Quality Risk Management approach did not change but if it is a second edition, there must be something improved and updated, right?


Let's start by remembering what GAMP 5 is!

GAMP®5 is known as ‘A Risk-Based Approach to Compliant GxP Computerized Systems’ and it provides a cost-effective framework for the risk-based approach to computer system validation. This good practice complies with European EMA and US FDA regulations (Annex 11 and 21 CFR part 11). It is designed to deliver systems which fits for their intended use. One of the well-known concepts is Software categorization that helps engineering and define required deliverables from the validation process.

The First edition has been available in many different languages since 2008. However, the developments in the world of technology and IT have made it necessary to review the 1st edition and adapt it to the era. Instead of releasing GAMP 6, they made the necessary updates and went on to release a new edition.

The purpose of the new guidance is to provide a cost-effective framework of good practices to ensure that Computerized systems are effective and of high quality, fit for its intended use and compliant with the applicable regulations and standards. It still aims to safeguard patient safety, product quality and data integrity.

So, what remained the same in this edition? 8 features of the guidance, which can be considered bone, were not changed. We can list them as follows.

  • Introduction
  • Key Concepts
  • Life Cycle Approach
  • Life Cycle Phases
  • Quality Risk Management
  • Regulated Company Activities
  • Supplier Activities
  • Efficiency Improvements
It is of great importance to understand what has changed as much as what remains the same. Let us have a look:
  • To achieve more control, better quality, and lower risks throughout the life cycle the technical part in the guide is updated to reflect the increased importance of the IT service providers including cloud service providers.
  • Other approaches for software development including incremental (Agile) and iterative models and methods are added.
  • The usage of software tools and automation is added.
  • Specific focus on IT infrastructure is added.
  • "Critical Thinking Through the Life Cycle" to Life Cycle Approach is given more attention in a separate section.
  • The application of patient-centric risk-based approaches versus primarily compliance driven approaches is added.
  • The application of Computer System Assurance (CSA) is introduced.
  • Guidance on application of new and developing technological areas like Artificial Intelligence, Blockchain, Machine Learning, cloud computing, Open-Source Software, ed. Is added
  • Additional guidance on specifying requirements and electronic records is provided.

As a result of the above listed additions and revisions the following has been removed:

  • The appendices on functional specification and repair are removed
  • The appendix on Managing Quality within an Outsources IS/IT environment is removed


So, there are extractions as there are add-ons. Of course, it will be better understood in the future how this will affect the user experience. After the innovations of the edition, let us talk about what the focal points of this edition are.

The updated guidance focuses on;

  • Encouraging critical thinking
  • Application of patient-centric, risk-based approaches versus primarily compliance-driven approaches
  • Emphasizing agility
  • Using Good IT practices
  • Excellence in software engineering
  • Automation and tools
  • Quality Risk Management approaches

As a result, GAMP 5 Second Edition is not a new approach, but rather a revision of an approach that has existed for almost 14 years.

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