SaaS & Cloud Validation: GxP Implementation Guide + Templates
SaaS & Cloud Validation: GxP Implementation Guide + Templates
Validate the Cloud stress-free. The ultimate operational guide for the Pharma world.
The adoption of Cloud and SaaS in the Life Science sector is no longer the future—it is the present. But how do you reconcile innovation and agility with strict FDA 21 CFR Part 11 and EU GMP Annex 11 requirements?
This guide is not the usual theoretical manual. It is a practical working tool, designed for QA Managers, IT Specialists, and Validation Experts who need to implement, validate, and maintain cloud systems in compliance with GxP.
Updated to GAMP 5 Second Edition principles and CSA (Computer Software Assurance) logic, this guide takes you step-by-step from validation strategy all the way to inspection preparation.
What You Will Learn
- Cloud Strategy: How to manage IaaS, PaaS, and SaaS models and the "Shared Responsibility Model."
- Regulations Explained: Essential requirements of FDA Part 11, Annex 11, and Data Integrity (ALCOA+) translated into practical actions.
- Vendor Management: How to audit and qualify Cloud vendors (even giants like AWS/Azure).
- Lifecycle: From URS to Go-Live, moving through Risk Assessment and optimized Testing (IQ/OQ/PQ).
- Audit Readiness: How to present a SaaS system to an inspector and avoid common observations.
📦 BONUS INCLUDED: The Operational Toolkit
Inside the guide, you will find 7 Checklists and 9 Ready-to-Use Templates to make your system "Audit-Ready" immediately:
- ✅ Checklists: Vendor Assessment, Part 11/Annex 11 Assessment, Data Integrity Check, Audit Prep, and more.
- 📝 Templates: Validation Plan, URS, Traceability Matrix, IQ/OQ/PQ Protocols and Reports, Change Control Register, and more.
Product Details
- Format: Professional PDF
- Pages: 188 pages
- Updated: January 2026
- Languages: ITA - ENG
DOWNLOAD A PREVIEW OF THE GUIDE
Couldn't load pickup availability
HAVE QUESTIONS? CHECK OUT OUR FAQS
What will I find in this guide?
In addition to operational explanations of the relevant regulations, you will find checklists, templates, real-life cases, and common mistakes to avoid.
How up-to-date is the guide?
The guide includes updated references to the latest EMA and EU GMP regulations, as well as guidance from all international inspection bodies. In the event of future revisions, we expect updates to be made available to buyers.
How long is it and how long does it take to read?
Each guide has a specific length based on the complexity of the topic, but they are all designed for quick reference. You can use it as a daily reference manual.
Who is this guide most useful to?
Junior professionals → to learn quickly and reduce errors.
Senior professionals → to have ready-to-use checklists and templates to share with the team.
Can I download it multiple times or share it?
Once purchased, you can download and keep it. It is for personal or internal business use only, but external redistribution is not permitted.