----- Message d'origine ----- De : Houston, Jim <Jim.Houston@stjude.org> À : Cytometry Mailing List <cytometry@flowcyt.cyto.purdue.edu> Envoyé : mardi 31 août 1999 16:57 Objet : QA/QC question for Lab Directors/Supervisors > > To All: > > I am in a debate about temperature charts, instrument QC charts etc. > > Currently I keep these on the instrument on a monthly basis. Each is > attached or is in a pouch on the instrumemt. A tech is responsible to daily > record infor on this chart. At the end of each month the chart is removed > sign by the director then put in a binder with previous months. This binder > has a section for each instrument. > > My new QA personnel is asking that I put a binder with all the info on or > near the instrument that will hold archival and current info for that > device. > > Question is, do you keep daily/monthly charts on the instruments or keep > them in a binder that is in close proximity? Are there any reulations that > require either method? > > Any input is welcome. > > Jim Houston > Dear Jim, You will find the answer to your question reading the GMP form the FDA and the ISO 9001 standard. Specially, in the GMP, you will find in the paragraph "Inspection, measuring, and test equipment" the following text : "These records shall be displayed on or near each piece of equipment or shall be readily available to the personnel using such equipment and to the individuals responsible for calibrating the equipment". Here, we choose, as your new QA personnel is asking you, to keep the records in a binder that is on the instrument or in close proximity. We think that it's the best and the more simple way to ensure traceability and quality for equipments. Hoping this helps you, we remain. Sincerely, Thomas VIGNERON, QA manager Thierry MAUNIER, QC manager
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