21 CFR Part 11 Issues

On August 20th, 1997, FDA regulation 21 CFR Part 11 came into effect. The purpose of Part 11 is to provide the criteria under which the FDA will consider electronic records, and electronic signatures, as being the equivalent to paper records and handwritten signatures.

These regulations now apply to all CGMP, GLP, GCP manufacturers, and those industries where FDA regulated record keeping systems are required to be maintained. The regulations are intended to permit the widest possible use of electronic technology, compatible with the Agency's responsibility to promote and protect public health.

The regulation also applies to standard operating procedures in which a firm says it will record and preserve certain information. The information to be recorded may not be specifically identified in a regulation but the firm imposes the requirements upon itself by virtue of its standard operating procedures.

The rule does not apply to those computer systems that are merely incidental to the creation of paper records that are subsequently maintained in traditional paper based systems. In these cases computers function essentially as manual typewriters or word processors, and any signatures would be traditional handwritten signatures.