Computerized System Validation (CSV) follows a traditional model, including terminology that has evolved globally but remains deeply rooted in practice. Today, we are experiencing technological advancement with increasing system complexity, yet CSV practices—even when based on risk assessment and management methodologies—still reflect an outdated paradigm: the belief that “the more documentation, the more effective the validation.”
This mindset, although historically understandable, is no longer sustainable in light of the new methods, tools, and systems currently available. There is inherent complexity in organizing and managing the excessive volume of information across the various validation documents and phases. In particular, this volume grows exponentially in SAP implementation or migration projects, making it necessary to establish a simple yet robust approach, as well as define methods and tools that support teams in navigating these challenges smoothly.