Quality Assurance and 21 CFR Part 11: A Holistic Approach
by Edward F. Ikeguchi, M.D., Chief Medical Officer
In 1997, the Food and Drug Administration delivered 21 CFR Part 11, providing explicit requirements for the utilization of electronic records and signatures in the drug development process
Since then, however, 21 CFR Part 11 has become mired in complex interpretations and difficulties in remediation, leading the industry to spend billions of dollars in achieving compliance. All too often, we hear of vendors who claim that their software is "21 CFR Part 11 Compliant", without consideration for the peripheral support variables that are so relevant to the creation of a compliant product.
