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.
The FDA has created several documents with the assistance of industry representatives, to offer guidance in interpretation of the requirements. Even with these efforts, the requirements are still somewhat of a moving target. Pilgrim Software is continuously monitoring the opinions of the FDA to ensure continued compliance with the requirements.
This document presents the requirements set forth in 21 CFR Part 11, along with Pilgrim Software's own interpretation of the requirements.