GxP risk assessments are carried out to determine the level of impact a computer system has on product quality, patient safety, or data integrity. Based on the intended use, the system falls into one of two categories: software that is used directly as part of production or the quality system and software that supports production or the quality system.
Conduct a thorough analysis, involve stakeholders, consider regulatory requirements, assess risks, and use established frameworks to classify the system based on its intended use. Properly classifying a system is crucial for implementing effective software assurance measures, as the level of assurance required often varies based on the system’s purpose, criticality, and potential impact. This classification is foundational for implementing effective software assurance practices tailored to the specific needs and risks of the software system.