Traditionally, a regulated company is accountable for all aspects of their infrastructure qualification and application validation. With the introduction of public cloud service providers (CSPs), part of that technical responsibility has shifted to a cloud supplier, making supplier assessment and supplier management more important than ever—even though the regulated company is still...
IT infrastructure has traditionally been provisioned using a combination of scripts and manual processes. This manual approach was slow and introduced the risk of human error, resulting in inconsistency between environments or even leaving the infrastructure in an unqualified state. In this article, we investigate some fundamental advantages of using Infrastructure as Code (IaC) for...
This article describes how ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) and related GAMP Good Practice Guides can be effectively applied to help meet the requirements of the proposed European Union (EU) artificial intelligence (AI) regulation for qualifying GxP-regulated systems employing AI and machine learning (ML).
This article provides a beginner’s overview of how organizations can achieve a state of preparedness (readiness) for inspections, with a specific focus on IT systems.
