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21 CFR Part 11 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.

This document presents the requirements set forth in 21 CFR Part 11, along with Pilgrim's own interpretation of the requirements.

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