The US Food and Drug Administration (FDA) published its electronic records and signatures regulation on March 20, 1997, taking effect from Aug. 20, 1997. The rule applies to any electronic record keeping activity which replaces traditional paper-based methods required by federal statute or regulation in all FDA-regulated areas.

According to recent US polls, less than 11 % of affected companies comply with 21 CFR Part 11 requirements. Despite this low percentage, manufacturers who acknowledge the direct benefits it affords them have readily accepted the Rule. It is apparent however that implementation requires an enormous restructuring procedurally, administratively and financially. When taking into account the complexities of fully implementing the Rule, together with the considerable financial investment it requires, there is little doubt that it will take several more years to achieve full compliance.

Although the FDA is fully aware of these difficulties, the increasing number of Warning Letters being issued is a clear indication that the agency is gradually adopting a firmer stance in its expectations for a more rapid and full deployment of the 21 CFR Part 11 requirements by those companies electing to adopt it.

These files are in Adobe PDF format.
Click on the "Get Acrobat Reader" icon on the left of the page to
download a free copy of the Acrobat Reader.

PDF file (266 KB)
Earlham College, 2002-07-29
"Our Investigator noted that the laboratory is using an electronic record system for processing and storage of data from the atomic absorption and HPLC instruments that is not set up to control the security and data integrity in that the system is not password controlled, there is no systematic back-up provision, and there is no audit trail of the system capabilities. The system does not appear to be designed and controlled in compliance with the requirements of 21 CFR Part 11, Electronic Records."

PDF file (642 KB)
Cardinal Enterprises, Inc., 2001-12-07
"Master production and control records are not prepared, dated, and signed by one person with a full handwritten signature and independently checked, dated and signed by a second person. Master production records are generated from a computer as electronic records without any apparent controls to assure authenticity and integrity."

PDF file (273 KB)
Sorenson Development, Inc., 2001-10-17
"Computer and/or automated data processing system softwar