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Your search results for „Validierung im GxP-Umfeld”

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Technical rule [CURRENT] 2013-09

VDI/VDE 3516 Blatt 1:2013-09
Validation in GxP area - Open-source software

This standard deals with the special features of free software and open-source software (OSS) compared with commercial software, and with the resulting procedure to be followed for the ...

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from 76.80 EUR VAT included

from 71.78 EUR VAT excluded

Technical rule [CURRENT] 2013-11

VDI/VDE 3516 Blatt 2:2013-11
Validation in the GxP area - Small manufacturing and testing devices

The scope of this standard is to provide guidance for an adapted and efficient use of FDA 21 CFR Part 11 and to provide guidance on a pragmatic validation approach for small manufacturing and ...

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This document also features in an online service. Online services not only give you electronic access to collections of standards, they contain lots of extra information too (such as directives, legal texts, commentaries, etc.). There are automatic updates on a regular basis – and online services also give you large savings compared with the cost of purchasing standards individually.

Suitable online services

from 155.50 EUR VAT included

from 145.33 EUR VAT excluded

Technical rule [CURRENT] 2016-07

VDI/VDE 3516 Blatt 3:2016-07
Validation in GxP-area - Alternative software development models and development methods

In this standard the following methods were selected and considered out of numerous methods of agile software development and project management that are applied today: scrum; extreme programming ...

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This document also features in an online service. Online services not only give you electronic access to collections of standards, they contain lots of extra information too (such as directives, legal texts, commentaries, etc.). There are automatic updates on a regular basis – and online services also give you large savings compared with the cost of purchasing standards individually.

Suitable online services

from 103.50 EUR VAT included

from 96.73 EUR VAT excluded

Technical rule [CURRENT] 2016-04

VDI/VDE 3516 Blatt 4:2016-04
Validation in GxP area - Automated testing

The standard describes the objectives and potential benefits of automated testing in the pharmaceutical environment. On the one hand, criteria are presented in order to make the use of test ...

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This document also features in an online service. Online services not only give you electronic access to collections of standards, they contain lots of extra information too (such as directives, legal texts, commentaries, etc.). There are automatic updates on a regular basis – and online services also give you large savings compared with the cost of purchasing standards individually.

Suitable online services

from 83.90 EUR VAT included

from 78.41 EUR VAT excluded

Technical rule [CURRENT] 2019-03

VDI/VDE 3516 Blatt 5:2019-03
Validation in the GxP area - Types of raw data

This standard is concerned primarily with raw data covering GxP rules. The archiving of data is only considered marginally in this context. The standard defines the essential terms to establish a ...

Online service subscriptions

This document also features in an online service. Online services not only give you electronic access to collections of standards, they contain lots of extra information too (such as directives, legal texts, commentaries, etc.). There are automatic updates on a regular basis – and online services also give you large savings compared with the cost of purchasing standards individually.

Suitable online services

from 83.90 EUR VAT included

from 78.41 EUR VAT excluded

Technical rule [CURRENT] 2021-08

VDI/VDE 3516 Blatt 6:2021-08
Validation in GxP area - Validation of interfaces

In many validation projects in the IT environment, the different interests of quality management, the suppliers involved and the operators of the systems with regard to interfaces and data ...

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This document also features in an online service. Online services not only give you electronic access to collections of standards, they contain lots of extra information too (such as directives, legal texts, commentaries, etc.). There are automatic updates on a regular basis – and online services also give you large savings compared with the cost of purchasing standards individually.

Suitable online services

from 155.50 EUR VAT included

from 145.33 EUR VAT excluded

Technical rule [CURRENT] 2020-11

VDI/VDE 3695 Blatt 1:2020-11
Engineering of industrial plants - Evaluation and optimisation of the engineering - Fundamentals and procedure

The standard can be applied to engineering organisations that plan, create and/or commission automated machines or plants. In addition to terms and definitions, the basics and the engineering ...

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This document also features in an online service. Online services not only give you electronic access to collections of standards, they contain lots of extra information too (such as directives, legal texts, commentaries, etc.). There are automatic updates on a regular basis – and online services also give you large savings compared with the cost of purchasing standards individually.

Suitable online services

from 58.00 EUR VAT included

from 54.21 EUR VAT excluded

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