January / February 2024

Emerging Leaders Editorial: What Is GAMP® & Why Is It Important?

Monique L. Sprueill, PMP
Emerging Leaders Editorial: Monique Sprueill

ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) outlines how to apply a risk-based approach to GxP computerized systems and is aligned with the FDA draft guidance “Computer Software Assurance for Production and Quality System Software.”

These practices ensure that computerized systems, which support manufacturing and other GxP operations, adhere to regulatory requirements, maintain data integrity, and consistently yield products that meet industry standards.

Critical Thinking for Computerized Systems

As Emerging Leaders (ELs), we should prioritize developing critical thinking. It is used to assess risk, determine the level of interaction with internal and external stakeholders, and ensure that the appropriate controls are established. GAMP® 5 Second Edition is an essential tool to help us prove that the systems we design, build, and deploy effectively operate as intended.

ISPE GAMP® 5 Second Edition focuses on the quality aspects in the application of agile frameworks, cloud computing, blockchain, artificial intelligence, and machine learning. It highlights the importance of critical thinking when executing quality risk management and throughout the system life cycle. According to the guide, “proactive adoption of a risk-based approach suitable for the intended use of the computerized system takes into account the multiple layers of assurance provided elsewhere within the business process”.1  It enables better project planning and execution.

Pharmaceutical research, development, and commercial operations rely on computerized systems for product quality, consistent yields, and business continuity. Drug approvals require successful clinical trials. How information is collected, managed, maintained, and distributed provides confidence in the reliability of trial data. Technical and functional specifications determine equipment capability requirements. During the entire life cycle of a drug, we use analytics to convey a state of control, equipment capabilities, and process performance information to management and stakeholders.

How to Apply GAMP Guides

ISPE GAMP Guides and Good Practice Guides cover the system life cycle, infrastructure, testing, operations, and innovation. They provide baseline information to help increase knowledge of computerized system compliance and computer software assurance and they demonstrate how to apply the principles.

The GAMP Global Steering Committee and the regional and local GAMP Communities of Practice (COPs) provide a platform for continuous learning and innovation. Actively participating in COPs is a great way to expand your network, increase your capabilities, and develop relationships with industry professionals. The ISPE Engage Open Forum is a space where you can ask questions with no fear of judgement, discuss ideas, and share lessons learned. You can also partner with others in your network to present at a conference, write a blog, or submit an article for inclusion in Pharmaceutical Engineering® magazine.

What Are the Next Steps?

If you are not a member of ISPE, join today ( Actively participate in Emerging Leader activities in your local Affiliate or Chapter. Access GAMP resources and connect with the GAMP Global Steering Committee. You can join a local GAMP CoP. Or, if there’s not one in your area, align with your local Affiliate or Chapter and start one. Add GAMP content, questions, and ideas to the ISPE Forum. Write a blog or article. Talk with your manager and colleagues about presenting your project at a conference or local program.


One of the first lessons I learned when I joined ISPE is that my network is one of the most valuable assets to acquire. People in your network will help you gain a better understanding of GAMP and how to apply the principles to ensure data integrity and regulatory compliance and that GxP-regulated information systems are properly maintained.

Learn More

  • 1International Society for Pharmaceutical Engineering. ISPE GAMP® 5 Guide: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition). North Bethesda, MD: International Society for Pharmaceutical Engineering, 2022.