Innovative integration best medicine: Navigating paths for effective plant-wide standard compliance

摘要

There's an approach to integrated process control that challenges engineers and project managers but also gives the plant more flexibility. Plants built on this model will require fewer personnel to maintain them. This model also successfully meets all 21CFR11 requirements regarding electronic records. The approach uses terminal server-based user interface, network-based authentication, centralized setpoint and recipe management via databases, and centralized Web-based reporting and data mining, This results in a standard mechanism for capturing all critical operator actions with a 21CFR11 compliant audit trail. When coupled with enhanced procedural controls, these solutions can provide a mechanism for 21CFR11 compliance that lowers downstream support costs.