January, 2001

The recent ratification of the Electronic Signatures in Global and Commerce Act, which provides legal status for electronic signatures, has caused the Food and Drug Administration (FDA) to intensify its enforcement of 21CFR Part 11 rules. These rules govern the creation of electronic records and electronic signatures so they become equivalent, in the eyes of the FDA, to paper records and signatures. As a result, pharmaceutical companies are moving quickly to retrofit existing systems to comply and are installing new systems for electronic documentation to comply with 21CFR11.

The FDA, Title 21 Code of Federal Regulation Part 11, was first announced in March 1997. This regulation enabled the pharmaceutical manufacturers to drastically reduce cost and increase efficiencies by eliminating paper records and saving critical process data in its electronic form. Among other things, the regulation requires the data to be saved on the original computer where it is collected and in a form that can't be manually modified without leaving an electronic trail of evidence or an "audit trail".

Thousands of electronic data collection systems that use Excel or some other electronic database without a built-in audit trail are no longer in compliance. It is too easy for an operator to access an Excel spreadsheet and manually change readings that are outside the acceptable range. Conversely, a database with an audit trail records precisely what is changed, thus confirming the authenticity of the data. An FDA inspector can easily confirm this authenticity with a properly configured SQL Server, Oracle Database, or some other self-auditing database.

These Electronic Batch Records also can be approved or disapproved by appropriate personnel when they use their identification IDs and passwords. This information, when electronically entered, now takes the place of authorizing signatures. The original architect of the FDA's 21CFR Part 11 Regulation was Paul Motise, who has also consulted closely with the pharmaceutical industry. Motise was recently quoted as saying, "Record management is a problem during audits almost all the time. This is caused by incomplete, contradictory, or nonexistent records."

Indeed, it is still true today that the FDA distributes more 483s related to documentation than any other issue. And, privately, many of Superior Controls' customers tell us that the FDA's enforcement of 21CFR Part 11 Regulation is noticeably more aggressive. This may be due, in part, to Paul Motise's move to the FDA's Office of Enforcement, where he recently completed a training program for inspectors.

Superior Controls is designing and implementing numerous systems using electronic batch records for pharmaceutical manufacturers. We are also retrofitting a number of existing systems to make them compliant with 21CFR11. For more information concerning this subject, contact Rick Pierro at Superior Controls.