VDI/VDE 3516 Blatt 2:1981-07
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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
Hardcopy , PDF
11-01-2020
English, German
01-07-1981
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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Withdrawn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 |
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| 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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