FDA 21 CFR Part 11 Compliance and Validation of a Titrator Software

In food and drug labs analytical devices typically work together with software and computers. In most cases the software is part of the instruments. The software produces so called ?electronic records?. This item ?electronic records? is defined by the FDA (Food and Drug Administration in the USA) as: Electronic record means any combination of text, graphics, data, audio, pictorial or other information representation in digital form, that is created, modified, maintained, archived, retrieved or distributed by a computer system [1]. Following this definition at least all information as e.g. analysis results and methods, stored on a computer are electronic records. As a consequence software in a FDA compliant lab has to be 21 CFR part 11 compliant. An important condition is the validation of the software beside the special part 11 requirements: Subpart B -- Electronic Records Sec. 11.10 Controls for closed systems. (a) Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records. In the following text both requirements are discussed, part 11 requirements as well as the software validation. As an example a software for titration control is used, TitriSoft 2.60 P [2]. Practical information about validation is described in [6]; this is quoted in this paper.