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Kniha Software Development for GxP Regulated Industries Adrian Krzesniak

Software Development for GxP Regulated Industries

Deliver GxP Compliance Software in an Agile Way

Autor: Adrian Krzesniak
Jazyk: Angličtina
Väzba: Brožovaná
Vydavateľ: Independently published
Dostupnosť: Skladom u dodávateľa
Odosielame za 10-18 dní
15.45 €
Software development for GxP-regulated companies involves additional requirements, including specifi...

Informácie o knihe

Autor
Adrian Krzesniak
Jazyk
Angličtina
Väzba
Kniha - Brožovaná
Vydalo
2025
Stránok
34
EAN
9798282856330
Enbook ID
53018224
Vydavateľ
Independently published
Hmotnosť
61
Rozmery
152 x 229 x 2

Kompletný popis

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.