Functional and System Requirements for Systems Regulated by FDA in 2024

Overview:

The validation of computer systems (CSV) under FDA regulations has shaped the way essential systems are designed, tested, and managed within FDA-regulated industries, including pharmaceuticals, biotechnology, medical devices, and more, for over 35 years. The requirements phase is an essential cornerstone of this validation, defining the critical functions and features that enable these systems to support safe and compliant operations across manufacturing, testing, and distribution.

Effective requirements development and management remain pivotal in FDA-regulated environments, serving as a foundation for compliant project execution. In the context of FDA oversight, any system that "touches" a product—whether during manufacturing, testing, distribution, or other critical operations—must adhere to these stringent standards. Building robust requirements means addressing multiple layers, from capturing functional needs to managing non-functional, or system, expectations, each of which aligns the system with both operational goals and regulatory demands.

The journey of requirements development touches on multiple facets. High-level requirements are often expressed in business terms, establishing a clear intention for system use. These overarching requirements then lay the groundwork for more detailed functional and non-functional specifications, each meticulously mapped to test scripts that validate compliance. Addressing requirements systematically is key, from assessing risk and rating each requirement’s impact to defining the scope of testing needed to confirm compliance.

CSV requirements extend beyond traditional documentation. They encompass practices that prevent "scope creep"—a common risk that drives up costs and prolongs timelines—as well as practices that safeguard operational efficiency and compliance. Clearly defined requirements ensure that projects stay on track, with a particular focus on functional and system-level specifics that meet user needs without compromising on regulatory compliance.

With these principles in mind, Computer Software Assurance (CSA) enters as an FDA draft guidance issued in 2022, offering a risk-based pathway to validation. CSA shifts the focus to functionality most critical to compliance and patient safety, emphasizing a streamlined approach that targets high-risk areas first. This draft guidance, along with GAMP®5’s updated second edition (issued in 2022), supports agile methodology for software development, aligning with modern needs for responsive and efficient validation processes. The "V" Model, long a standard in GAMP®5, shows flexibility in combining CSA principles with agile development and testing, balancing regulatory rigor with adaptive project management.

Throughout this process, requirements traceability becomes invaluable. The Requirements Traceability Matrix (RTM) captures each requirement’s relationship with test scripts, reinforcing compliance from specification to execution. This approach not only supports thorough testing but also enables systematic monitoring of each requirement’s risk profile, addressing both functional and non-functional needs at every phase.

This course, in its detailed exploration, will address these best practices for preparing detailed requirements within CSV, including crafting acceptance criteria that affirm compliance through targeted testing.

Areas covered during the session:

• Learn the characteristics of well-written requirements
• Learn where to gather information and who to speak with when preparing a requirements specification
• Understand the importance of clearly written, well-defined requirement definition
• Understand how the requirements will set the tone for CSV testing
• Learn about the Requirements Traceability Matrix (RTM) that links every requirement with one or more test scripts that support it
• Learn how to rate the potential risk of a requirement failing and how this influences testing during CSV
• Identify functional vs. non-functional, or system requirements
• Understand the approach for software development following GAMP®5, Second Edition and FDA’s draft guidance for Computer Software Assurance (CSA); these two are very aligned
• Learn how to capture the requirements electronically
• Q&A

Why should you attend?

In FDA-regulated industries, managing system requirements is critical for compliance, efficiency, and cost control. This webinar will equip you with best practices to develop robust requirements for Computer System Validation (CSV), minimizing project risks and preventing costly scope creep.

Gain clarity on the FDA’s latest guidance on Computer Software Assurance (CSA) and its practical applications for a risk-based approach. This insight will help you streamline validation processes, focusing efforts where they matter most for compliance.

By joining, you’ll be better prepared to meet evolving regulatory expectations while strengthening your validation practices, from requirements documentation to agile project management. This session is invaluable for professionals seeking efficient, compliant CSV strategies.

What industries will benefit from your training?

Manufacturing, Testing, Packaging and Distribution companies in the following industries that are regulated by FDA are required to follow GxPs:

• Pharmaceutical (for drug products introduced using a medical device)
• Medical Device
• Biologicals (for biological products introduced using a medical device)
• Tobacco (based on the Tobacco Control Act of 2009)
• E-Liquid/Vapor (based on the “Deeming” Act of 2016)
• E-Cigarette (based on the “Deeming” Act of 2016)
• Cigar (based on the “Deeming” Act of 2016)
• Third-Party companies that support those in the above industries, including Contract Research Organizations (CROs)
• Colleges and Universities offering programs of study in Clinical Trial Management and Regulatory Affairs/Matters related to FDA

Who will benefit?

Personnel in the following roles will benefit:

• Information Technology Analysts
• QC/QA Managers
• QC/QA Analysts
• Clinical Data Managers
• Clinical Data Scientists
• Analytical Chemists
• Compliance Managers
• Laboratory Managers
• Automation Analysts
• Manufacturing Managers
• Manufacturing Supervisors
• Supply Chain Specialists
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders responsible for computer system validation planning, execution, reporting, compliance, maintenance and audit
• Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance
• Auditors engaged in the internal inspection of labeling records and practices.