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Process analytical equipment for fluids
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Available format(s): Hardcopy, PDF
Withdrawn date: 11-01-2020
Language(s): English, German
Published date: 01-07-1981
Publisher: Verlag des Vereins Deutscher Ingenieure
Preliminary noteIntroduction1 Scope2 Normative references3 Abbreviations4 Definitions of classes5 Exceptions - systems with automated calibration6 Mapping of classes between 'GAMP GPG - Validation of Laboratory Computerized Systems' and this standard7 Requirements for life cycle documentation8 Case studies9 21 CFR Part 11 requirementsAnnex A - Example formsAnnex B - Functional testing requirementsAnnex C - Test document structure exampleAnnex D - Access control matrixAnnex E - Example of a class A or a class B qualificationGlossaryBibliography
Describes PC or higher 'computerized systems', which are capable of the described administration functions for ERES (audit trail, user management, etc.).
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