Laggardly implementation
Takting stock four years after the introduction of 21 CFR Part 11

Hardly a regulation caused such a stir in past years as 21 CFR Part 11. After all, laboratory instruments, production equipment or chromatographs possibly come under the computer validation. Which makes it all the more surprising that in many areas the theme is only approached half-heartedly.
Almost all large pharmaceutical companies have begun with the start-up. The SOP (Standard Operating Procedures), as one wants to implement Part 11 in the company, are approved. The first trainings have been carried out; a start has been made on the gap analysis, i.e. in establishing which systems have which gaps. There is hardly a company though, in which this examination has already been completed. The completion of the gap analysis is often planned for the end of 2002. The implementation of the measures resulting from it, the upgrading or replacement of systems, for around the middle of 2004. The financial means for the concern-wide gap analysis have as a rule been made available, but not those for the implementation of the measures.