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What Is FDA 21 CFR Part 11 And Are Your Systems Compliant?

Source: Infitrak, Inc.

21 CFR Part 11 is federal statutory provision designed to codify specific Best Practices for certain industries. Particularly, it authorizes commercial entities to establish and utilize computerized networks that exponentially enhance individual productivity levels via drastic reduction of manual data entry errors.

Each section of the Code of Federal Regulations ("CFR") addresses a different aspect of U.S.governmental agency operations. The typical pattern is that each provision imposes regulatory protocols for archived records and authentication signatures that were originally denoted as "handwritten signature" and "paper documents." Revised 21 CFR Part 11 FDA Compliance rules permit full replacement of obsolete paper files with electronic media along with ink signature affixation replacements with electronically imprinted signatures.