FDA Software Validation: What’s Changed?

CGMP-regulated companies are required to establish and implement formal software Verification and Validation (V&V) processes for medical products in alignment with IEC 62304 and key U.S. FDA guidance documents.

Managing software and associated hardware across design, development, verification, and validation phases can be complex, requiring structured documentation and strict regulatory control. This session focuses on effective planning, execution, and documentation of software V&V activities used in medical device and pharmaceutical manufacturing environments.

The program covers validation approaches for commercial off-the-shelf (COTS), custom-built, and cloud-based systems, along with practical implementation of an FDA-recommended model aligned with IEC 62304 and recent FDA guidance updates. Real-world examples of V&V documentation and test cases will be discussed, with special emphasis on current FDA concerns and expectations.

Software categories addressed include:

1. Production and testing systems
2. Quality Management Systems (QMS) and 21 CFR Part 11 compliance
3. Cybersecurity and networked environments

Areas Covered -

1. Evolving FDA expectations and regulatory requirements, including cybersecurity
2. Core roles and principles of software Verification and Validation
3. Alignment with IEC 62304 and updated FDA guidance
4. FDA-recommended V&V documentation model (10 key documents)
5. Structure of V&V protocols and test reports (black-box and white-box testing)
6. Overview and implementation of 21 CFR Part 11
7. Validation strategies for legacy, hybrid, and modern (ER/ES) systems
8. Regulatory deliverables and documentation expectations
9. Cybersecurity considerations in software validation

Benefits of Participating -

Software validation continues to be a critical focus area for regulatory agencies. With increasing reliance on software-driven systems in manufacturing, testing, and quality management, organizations must adopt robust and compliant V&V practices.

This session explains how to apply IEC 62304 in alignment with the FDA’s latest guidance, including its relevance to 510(k) submissions. It also highlights key considerations such as 21 CFR Part 11 compliance, cybersecurity risks, and cloud-based system challenges.

Participants will gain insights into:

1. Addressing common FDA inspection findings and compliance gaps
2. Implementing a risk-based approach to software validation
3. Developing standardized and repeatable V&V documentation
4. Minimizing software-related failures through effective validation strategies

Ideal Participants -

This webinar is designed for professionals working in FDA-regulated environments, particularly within medical device and combination product industries.

It will be valuable for:

1. Senior Management
2. Regulatory Affairs Professionals
3. Quality Assurance and Quality Engineering Teams
4. Production and Manufacturing Personnel
5. Engineering, R&D, and Software Development Teams

It is especially relevant for organizations implementing or upgrading software-driven systems, transitioning to paperless or cloud-based environments, or managing QMS, ERP, and MRP systems under regulatory compliance requirements.