抄録
In October 10, 2013, the ERES (Electronic Records, Electronic Signatures) Committee of PDA Japan Chapter held the symposium titled “Tide of the Computerized Systems in the Pharmaceutical Industry —Impact of PIC/S for the computerized system in the pharmaceutical industries, and CSV (Computerized System Validation) latest information”. We report the outline of the symposium.
In recent years, new technology, such as Cloud and virtualization, is being introduced into the various industrial worlds, and it is addressed the challenge in the pharmaceutical industry how to validate computerized systems in the case of using such services.
Although the discussion on CSV has become obsolete in recent years, it can say that new subjects, such as correspondence to new technology, are appearing.
While EU GMP Annex 11 was reformed, it was adopted also as PIC/S, and we are brighten our prospects of amendment of the CSV guidance (PI 011-3) which will be published by PIC/S.
On this opportunity, inviting one of GMP inspector of Europe and a consultant who detailed to the CSV, we held the symposium on the newest subject of EU and PIC/S GMP, as well as obtaining the lecture about the devices and efforts towards affiliation of Japan to PIC/S by Mr. Hiyama of former National Institute of Health Sciences Japan. We also presented discussions from our ERES committee on that field.
The point “Conquest of confliction between a project team and a validation team” which Mr. Stokes, one of invited speaker, displayed the best way for overcome to a new current. Moreover, Mr. Menges, another invited speaker, saying that the focus of Annex 11 is in an operation phase, we can regard as having suggested tacitly that also coming to nothing efforts of project duration and fruiting and making the operation phase over a long period of time farther than a project phase have started constant efforts of those who take charge of it.
It is also strongly impressed in Mr. Hiyama's lecture, a sincere efforts of the persons related to the PIC/S affiliation of Japan.
