Computer Software Assurance (CSA) – Operational GxP Guide
Computer Software Assurance (CSA) – Operational GxP Guide
Computer Software Assurance (CSA) is the risk-based approach promoted by the FDA for the validation of GxP software, based on the principle “Assurance over Documentation.”
This operational guide shows how to apply CSA in a practical way, moving beyond the traditional CSV model and transforming regulatory requirements into operational activities, risk-proportionate testing, and audit-ready documentation.
What you will find in the guide
- CSA regulatory framework (FDA, Annex 11, GAMP 5, ICH Q9)
- Differences between traditional CSV and CSA
- Risk assessment and functionality classification
- Scripted and exploratory testing in line with CSA
- Evidence management and audit readiness
- Application to Cloud and SaaS systems
Target audience
QA, CSV/CSA Managers, IT, Validation, Regulatory Affairs, and QP.
Product details
Format: Professional PDF
Pages: 120 pages
Updated to: January 2026
Languages: ITA – ENG
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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.