Validation in GxP Area - Open Source Software

Outlined is the particularitie of free and open-source software (OSS) in contrast to commercial software and the resulting approach to qualification and operation of OSS in GxP-regulated areas.

Publication date: 2012-09

Validation in the GxP area - Small manufacturing and testing devices

The scope of this guideline is to provide guidance for an adapted and efficient use of FDA 21 CFR Part 11 in regard to small devices by considering possible risks, efficiency and the sense and... Read abstract

Publication date: 2012-07

Safety of machinery - Safety-related parts of control systems - Part 2: Validation (ISO 13849-2:2012); German version EN ISO 13849-2:2012

Publication date: 2013-02

Validation of control systems - Execution of process control projects subject to validation (prospective validation)

This document describes the validation of control systems and the execution of process controll projects subject to validation (prospective validation)

Publication date: 2003-05

Validation of control systems - Retrospective validation of legacy systems

The document describes the validation of control systems and retrospective validation of legacy systems.

Publication date: 2003-05

Validation of control systems - Validation support by use of control systems

The document describes the validation of control systems and validation support by use of control systems.

Publication date: 2003-05

Road Traffic Signal Systems - Part 500: Safety related Software for road traffic signal systems

Publication date: 2008-01

Nuclear power plants - Instrumentation and control systems important to safety - Software aspects for computer-based systems performing category A functions (IEC 60880:2006); German version EN 60880:2009

Publication date: 2010-03

Medical device software - Software life-cycle processes (IEC 62304:2006); German version EN 62304:2006

This document has been corrected

Publication date: 2007-03

XML in automation - Transfer of domain models in XML

This guideline describes typical application scenarios of XML technologies in automation. Typical requirements and a systematic procedure model are described. This procedure model gives hints for an... Read abstract

Publication date: 2012-04