VDI/VDE 3516 Blatt 2:1981-07
Withdrawn
Process analytical equipment for fluids
Hardcopy , PDF
English, German
07-01-1981
01-11-2020
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Withdrawn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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