ABSTRACT
Food and Drug Administration (FDA) regulation 21 CFR Part 11 does not apply specifically to laboratory environments, and does not explicitly modify the good laboratory practices (GLPs). It is difficult to conceive, however, of a laboratory not fundamentally affected by Part 11, and it is all but impossible for a laboratory to interpret and comply with the GLPs without considering Part 11 as a critical context for interpretation. In short, Part 11 has defined the obligations of management in any environment-laboratory, research, production, or clinical testing-in which automated systems are
a critical part of the mix. No doubt there is somewhere a laboratory that does not rely on a computer-controlled testing component, does not record information into a database, does not use a statistical analysis software package, and does not rely upon any automation. Increasingly, however, such laboratories are fading into extinction. In all modern facilities, Part 11 becomes a major part of the regulatory mix.
