CFR Part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures sets forth the requirements for the creation, modification, maintenance, archival, retrieval, and transmittal of electronic records, and also the use of electronic signatures when complying with the Federal Food, Drug and Cosmetic Act or any other Food and Drug Administration (FDA) regulation. These rulings became law in March 1997. Since that time, both industry and the FDA have been working to interpret the meaning and intent of Part 11, especially as technology is evolving. The IQVIA SmartSolve team is continuously monitoring the opinions of the FDA and furthering discussions with them as new technology and capabilities evolve, to ensure continued compliance support with the requirements. This whitepaper includes IQVIA SmartSolve®’s Position Regarding 21 CFR Part 11 Requirements.
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