TThe U.S. Food and Drug Administration (FDA) mandates that computerized systems used in medical product production and quality assurance are validated to ensure consistent performance and compliance with regulatory standards. This validation encompasses the qualification of computer networks that support these systems. The Good Automated Manufacturing Practice (GAMP) framework offers a structured, risk-based methodology for such validation efforts.

FDA Requirements

The FDA’s guidance document, “Computer Software Assurance for Production and Quality System Software,” emphasizes a risk-based approach to establish confidence in automated systems used in manufacturing and quality processes. This approach involves:

• Risk Assessment: Identifying and evaluating potential risks associated with the computerized system to prioritize validation activities based on their impact on product quality and patient safety.
• Assurance Activities: Implementing appropriate assurance measures, such as testing and verification, to mitigate identified risks and ensure the system functions as intended.
• Documentation: Maintaining comprehensive records of validation activities, including risk assessments, test results, and any deviations encountered during the process.

This guidance supplements the FDA’s “General Principles of Software Validation” and supersedes certain sections related to automated process equipment and quality system software.

GAMP Framework

GAMP 5 provides a comprehensive framework for validating computerized systems, including the underlying IT infrastructure. It categorizes software systems to determine the extent of validation required:

• Category 1 – Infrastructure Software: Operating systems, database management systems, and network components. Validation focuses on ensuring these foundational elements are installed correctly and function reliably.
• Category 3 – Configured Software: Standard software configured to meet specific user requirements. Validation includes verifying that configurations align with intended use and regulatory standards.
• Category 4 – Bespoke Software: Custom-developed applications tailored for specific processes. These require extensive validation to ensure they meet all specified requirements and function as intended.

The GAMP 5 validation lifecycle involves:

1. Planning: Defining the scope, objectives, and strategy for validation activities.
2. Specification: Documenting user and functional requirements that the system must fulfill.
3. Risk Assessment: Evaluating potential risks to determine the level of validation effort needed.
4. Verification: Conducting testing and reviews to confirm the system meets specified requirements.
5. Reporting: Compiling validation findings and obtaining necessary approvals.
6. Maintenance: Implementing change control and periodic reviews to ensure ongoing compliance.

This structured approach ensures that computerized systems, including their network components, are validated appropriately, aligning with FDA requirements and industry best practices. By integrating FDA guidelines with the GAMP framework, organizations can effectively validate their computer networks, ensuring compliance and maintaining the integrity of their manufacturing and quality systems.