Compliance with 21 CFR Part 11 for Spotfire Products

This white paper outlines the compliance of Spotfire products with the Code of Federal Regulations Title 21 Part 11, which establishes requirements for electronic records and electronic signatures in regulated industries. It details the procedural and functional requirements that Spotfire has implemented to ensure its software meets FDA guidelines. The document describes various capabilities of the Spotfire platform, including data management, visualization, and analytics, which support compliance with regulatory standards. It also highlights the validation processes, quality management systems, and security measures in place to protect sensitive information. The paper emphasizes the importance of system validation and the role of qualified personnel in maintaining compliance. Additionally, it discusses the integration of customer feedback into product development and the continuous improvement processes that are part of Spotfire's software development lifecycle. Overall, the white paper serves as a comprehensive resource for understanding how Spotfire products align with regulatory requirements.