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VDI/VDE 3516 Blatt 2:1981-07

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

Process analytical equipment for fluids
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Withdrawn date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 note
Introduction
1 Scope
2 Normative references
3 Abbreviations
4 Definitions of classes
5 Exceptions - systems with
  automated calibration
6 Mapping of classes between
  'GAMP GPG - Validation of Laboratory
  Computerized Systems' and this
  standard
7 Requirements for life cycle
  documentation
8 Case studies
9 21 CFR Part 11 requirements
Annex A - Example forms
Annex B - Functional testing
          requirements
Annex C - Test document structure
          example
Annex D - Access control matrix
Annex E - Example of a class A or
          a class B qualification
Glossary
Bibliography

Describes PC or higher 'computerized systems', which are capable of the described administration functions for ERES (audit trail, user management, etc.).

DocumentType
Standard
Pages
28
PublisherName
Verlag des Vereins Deutscher Ingenieure
Status
Withdrawn

EN 61115:1993 Expression of performance of sample handling systems for process analyzers
VDI/VDE 3516 Blatt 4:2016-04 Validation in GxP area - Automated testing

DIN EN ISO 11135:2014-10 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11135:2014)
EN ISO 19011:2011 COR 2011 GUIDELINES FOR AUDITING MANAGEMENT SYSTEMS (ISO 19011:2011)
DIN EN ISO 14644-1:2016-06 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 1: CLASSIFICATION OF AIR CLEANLINESS BY PARTICLE CONCENTRATION (ISO 14644-1:2015)
ISO 19011:2011 Guidelines for auditing management systems
DIN EN ISO 19011:2011-12 GUIDELINES FOR AUDITING MANAGEMENT SYSTEMS (ISO 19011:2011)
ISO/IEC 25051:2014 Software engineering Systems and software Quality Requirements and Evaluation (SQuaRE) Requirements for quality of Ready to Use Software Product (RUSP) and instructions for testing
ISO 11135-1:2007 Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
PREN ISO 14644-1 : DRAFT 2010 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 1: CLASSIFICATION OF AIR CLEANLINESS BY PARTICLE CONCENTRATION
VDI 1000:2017-02 VDI Standardisation Work - Principles and procedures
PREN ISO 11135 : DRAFT 2011 STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO/DIS 11135:2011)
ISO/IEC 12119:1994 Information technology Software packages Quality requirements and testing
DIN EN ISO 11135-1:2007-08 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
DIN EN 12469:2000-09 BIOTECHNOLOGY - PERFORMANCE CRITERIA FOR MICROBIOLOGICAL SAFETY CABINETS
EN ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)
ISO 14644-1:2015 Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration
EN 12469:2000 Biotechnology - Performance criteria for microbiological safety cabinets
EN ISO 14644-1:2015 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration (ISO 14644-1:2015)

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