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CFR Part 11 White Paper
Pilgrim Software's position regarding 21 CFR Part 11
requirements 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. Since
these rulings became law in March 1997, the FDA has created several documents
with the assistance of industry representatives to offer guidance in interpretation
of the requirements. But even with these efforts, the requirements are still somewhat
of a moving target. This document presents the requirements
set forth in 21 CFR Part 11, along with Pilgrim Software's own interpretation
of the requirements.
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