Management of computer systems facing the inspection in pharmaceutical companies

Abstract

  The Electronic Records and Electronic Signatures Committee of PDA Japan Chapter, which is abbreviated to be ERES Committee as follows, started with examining and discussing the effect of 21 CFR Part11 which is US regulation about the electronic record/e-signature and the correspondence of the Japanese relevant regulation in November, 2001.
  Thereafter, the ERES committee has been assuming activities as a main target to hold translation/the publication of the references, as well as seminars on ERES so that the pharmaceutical industry could be developed through our efforts to make the most use of the sane corporate development by the electronic technique.
  The committee has approximately 40 members registered now, and it leads and holds some subcommittees, which perform the information sharing between committees, the examination of the measures in the guide and guidelines along with the regulations.
  We hereunder show the achievement of the inspection subcommittee which gave a presentation by the 16th annual PDA Japan Chapter Meeting conducted in November, 2009, as the partial introduction of the ERES committee activity concerned.