21 CFR Part 11 Compliance with TIBCO Statistica

Many of our customers in FDA-regulated industries, such as the design and manufacturing of pharmaceutical, food, and medical device products, rely on TIBCO Statistica™ as an integral software tool for their research, development, and quality control processes for meeting FDA 21 CFR Part 11 regulations. Compliance with 21 CFR Part 11 entails both procedural and software requirements, and Statistica software helps meet all of them: "Part 11 applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in Agency regulations."

Download this datasheet for details on how Statistic can help you meet Part 11 requirements.

Download Resource