Aligning and Shaping Regulatory Requirements
Posted: Sun Feb 09, 2025 8:21 am
In process controls, AI can help identify trends (product composition, packaging dimensions, production environmental controls, and so on) and provide in process calibration prior to a deviation beyond tolerance, or to identify early where a trend to a tolerance breach will occur. This can optimize manufacturing processes, reduce waste, minimize the impact of global remediations and, in turn, this pulls through to reducing risk of supply, quality, and safety issues. A simple CI/end-to-end quality russia rcs data activity is the use of digital tools to execute quality control reviews and record documentation in digital format for consumption across the organization.
The implementation of CI and end-to-end quality has significant implications for regulatory compliance. By providing a comprehensive, real-time view of all quality-related data, these approaches can streamline regulatory submissions and inspections. They also support the growing regulatory emphasis on quality-by-design principles and continuous process verification.
CI and AI-driven regulatory intelligence, in the context of quality-controlled procedures, can support the gathering of global submission requirements and the creation of global submission content, which will then be subject to human review as part of QC. How these technologies are used is also shaping the regulations themselves as seen with the EU AI Act and other global acts that are in development.
The implementation of CI and end-to-end quality has significant implications for regulatory compliance. By providing a comprehensive, real-time view of all quality-related data, these approaches can streamline regulatory submissions and inspections. They also support the growing regulatory emphasis on quality-by-design principles and continuous process verification.
CI and AI-driven regulatory intelligence, in the context of quality-controlled procedures, can support the gathering of global submission requirements and the creation of global submission content, which will then be subject to human review as part of QC. How these technologies are used is also shaping the regulations themselves as seen with the EU AI Act and other global acts that are in development.