This webinar takes a project-management approach to validating a computer system regulated by FDA, walking through five phases — system planning, development, implementation, operations and maintenance, and retirement — and showing how they align with the phases of validation. It follows a System Development Life Cycle (SDLC) approach to validation and to maintaining a system in a validated state, and includes 21 CFR Part 11 and data integrity compliance.

The session explores best practices for evaluating FDA-regulated systems based on size, complexity, business criticality, GAMP 5 category, and risk assessment — where risk reflects the probability, severity, detectability, and available mitigation should a system fail, with attention to impacts on data integrity, process and product quality, and patient safety. It covers FDA’s draft guidance on Computer Software Assurance (CSA), the GAMP 5 2nd Edition, and the move toward non-linear development such as agile, AI, and ML.

It also addresses validating and qualifying all components of FDA-regulated systems, including cloud-based servers and Software-as-a-Service (SaaS) solutions, and provides a roadmap for vendor audits and Installation Qualification (IQ). Finally, it shows how to use AI, ML, and Large Language Models such as ChatGPT to facilitate the project-management approach — supporting information gathering, documentation, and communication. The session closes with industry best practices and a Q&A.

The five project-management phases covered:

Phase 1: System Planning

Phase 2: System Development

Phase 3: System Implementation

Phase 4: System Operations & Maintenance

Phase 5: System Retirement

After this webinar, attendees will be able to answer -

• How do the five phases of project management align with the phases of computer system validation?
• How is a risk-based CSV approach built from size, complexity, business criticality, and GAMP 5 category?
• How does FDA’s draft Computer Software Assurance (CSA) guidance, with GAMP 5 2nd Edition, streamline validation?
• How are cloud-based servers and SaaS solutions validated, audited, and qualified (including IQ)?
• How can AI, ML, and ChatGPT assist information gathering, documentation, and communication on a validation project?
• How do you keep a validated system in that state through its entire life cycle?

This webinar benefits the following agencies -

The session is built around U.S. FDA computer system validation expectations and references 21 CFR Part 11, FDA’s Computer Software Assurance (CSA) draft guidance, GAMP 5 (2nd Edition), and data integrity principles. It is relevant to organizations validating systems in FDA-regulated industries.

Who should attend?

Personnel in the following roles will benefit:

• Information Technology Analysts, Developers, and Testers
• Software Quality Assurance Professionals
• QC/QA Managers and Analysts
• Compliance and Audit Managers; Laboratory Managers
• Regulatory Affairs and Submissions Specialists
• Computer System Validation Specialists
• Vendors responsible for software development, testing, and maintenance