Software Solutions & Services

GAMP categories for computerized systems

Not all computerized systems require the same validation approach. GAMP categories help you classify systems by complexity and focus your validation efforts where the risks are greatest. Discover what each category means and how it can guide your validation strategy.

About this expert article

If you're new to computerized systems validation, GAMP terminology and categories can quickly become confusing. Yet understanding these categories is an important starting point for determining how a computerized system should be validated.

This expert article introduces GAMP and explains how its software categories help classify computerized systems according to their complexity. You'll learn how this classification can influence the validation route and documentation needed to demonstrate that a system is suitable for its intended use and complies with GxP requirements.

With practical examples for each category, the article helps you distinguish between infrastructure, non-configurable, configurable and custom software, and understand why increasing complexity calls for greater attention to risks involving data integrity, product quality and patient safety.

Key Takeaways

• Understand what GAMP is and why it matters. Get a straightforward introduction to Good Automated Manufacturing Practices and their role in guiding computerized systems compliance in regulated industries.

• Learn how GAMP categories support a risk-based validation approach. Understand how categorizing systems by complexity helps focus validation efforts on the areas that present the greatest risk.

• Distinguish between GAMP categories 1, 3, 4 and 5. Explore the differences between infrastructure, non-configurable software, configurable software and custom or bespoke solutions.

• Recognize common examples for each category. See where operating systems, standard software, LIMS, ERP systems, spreadsheets, PLCs and custom-developed solutions fit within the GAMP framework.

• Understand configuration versus customization. Learn what qualifies as system configuration and why adapting existing functionality is different from modifying the original functionality of the software.

• Turn categorization into a validation strategy. See how the complexity of your system can help determine the appropriate validation route and supporting documentation, while keeping the focus on significant risks.

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