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Книга Software Development for GxP Regulated Industries Adrian Krzesniak

Software Development for GxP Regulated Industries

Deliver GxP Compliance Software in an Agile Way

Автор: Adrian Krzesniak
Език: Английски език
Корици: С меки корици
Издател: Independently published
Наличност: Външен склад
Изпращаме след 10-18 дни
16.35 € 31.98 лв
Software development for GxP-regulated companies involves additional requirements, including specifi...

Информация за книгата

Автор
Adrian Krzesniak
Език
Английски език
Корици
Книга - С меки корици
Издадена
2025
страници
34
EAN
9798282856330
Enbook ID
53018224
Издател
Independently published
Теглоt
61
Размери
152 x 229 x 2

Пълно описание

Software development for GxP-regulated companies involves additional requirements, including specific guidelines from EU Annex 11, and FDA CFR Part 11. These requirements cover aspects such as electronic signatures, audit trails, data integrity, and more. Due to the stringent regulations governing GxP-regulated companies, software and system suppliers must adhere to established rules and procedures for developing, releasing, implementing, and maintaining software.
When validation or pre-validation is needed, this book explains how to implement agile validation by embedding the validation process within the development cycle, rather than using the traditional V-Model validation based on the waterfall approach.
In this book, you will find valuable information to help you develop and make software attractive from a compliance point of view for GxP-regulated industries, including pharmaceuticals, laboratories, clinical trials, and the broader life sciences sector.
You will also find numerous tips on how a software development vendor can prepare for a supplier audit conducted by a GxP-regulated company.