Posts by Leire Zúñiga
September 25, 2025
FDA Final Guidance on Computer Software Assurance Released
On 24th Sept 2025, the FDA published its final guidance on Computer Software Assurance (CSA) for production and quality system software. What’s new?CSA formalizes a risk-based approach to ensure software used in production and quality systems is fit for its intended use and remains in a validated state throughout its lifecycle: Risk drives validation: Identify […]
September 12, 2025
ICH E6(R3) in the USA: Current Landscape
On 08th September 2025, the U.S. Food and Drug Administration (FDA) published its final guidance for industry on ICH E6(R3) Good Clinical Practice. This guidance aligns with the new ICH principles and aims to support adoption of flexible, risk-based approaches, and promotes innovations in trial design, conduct, and use of technology. E6(R3) Good Clinical Practice […]
January 28, 2025
ICH E6(R3) Step 5 Adoption Announced by EMA
The European Medicines Agency (EMA) has announced the adoption of the ICH E6(R3) Guideline for Good Clinical Practice (GCP) at Step 5. The guideline is set to come into effect on 23 July 2025, allowing stakeholders sufficient time to prepare for its implementation. For more information, visit the EMA website.