AVO Chief

An important consideration in evaluating the impact of  FirstDoc/Documentum-based applications in helping meet 21 CFR Part 11 compliance is whether the specific system implementation is considered a closed or open system.  The FDA provides the following definitions in 21 CFR Part 11 for closed and open systems: Closed system means an environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system. Open system means an environment in which system access is not controlled by persons who are responsible for the content of electronic records that are on the system. Closed System Controls For closed systems there needs to be a way for “validation of the systems to ensure accuracy, reliability, consistent intended performance and the ability to discern invalid or altered … Read entire article »