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Sie suchen in allen Bereichen nach dem Autor Gattig P.
In der Rubrik Zeitschriften haben wir 1 Beitrag für Sie gefunden
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MerkenComputer-aided Assurance of Risk Documentation within an Existing FMEA Landscape
Rubrik: IT
(Treffer aus pharmind, Nr. 06, Seite 851 (2019))
Computer-aided Assurance of Risk Documentation within an Existing FMEA Landscape / Gattig and Langguth • Risk Documentation · Gattig P, Langguth P · 1Department of Biopharmaceutics and Pharmaceutical Technology, Johannes Gutenberg University Mainz and und 2Boehringer Ingelheim, Focus Factory Respimat, Ingelheim am Rhein
Appropriate risk management methods and tools have been an integral part of industry for many years and are required by regulatory authorities [ 1 ][ 2 ][ 3 ]. They provide the risk identification and evaluation, the quality assurance, the know-how retention in the company, the process planning as well as the proof of a structured and complete consideration of the process [ 4 ]. Failure Mode and Effects Analyses (FMEAs) are well suited to accomplish these tasks. The creation of an FMEA is a team effort by members of various disciplines. In addition to the moderator, who does not ...
