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Validierung in der Prozeßleittechnik
Author(s) -
Hensel Hartmut
Publication year - 1996
Publication title -
chemie ingenieur technik
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.365
H-Index - 36
eISSN - 1522-2640
pISSN - 0009-286X
DOI - 10.1002/cite.330680104
Subject(s) - process (computing) , control (management) , task (project management) , quality (philosophy) , control system , computer science , process control , process validation , systems engineering , engineering , process management , manufacturing engineering , operations management , verification and validation , artificial intelligence , operating system , philosophy , electrical engineering , epistemology
Process control systems are being increasingly introduced in pharmaceutical production plant. They exercise quality‐relevant functions and are thus subject to legal requirements of validation. It must therefore be established and documented that a process control system fulfills specific requirements. The technical part of this task lies in qualification of the process control system. The present article described the basic principles of such process control system qualification, services for setting up a process control system with obligatory validation, qualification‐oriented control system functions, and support of the control system manufacturer in validation.