Software Development for GxP Regulated Industries: Deliver GxP Compliance Software in an Agile Way

Link https://a.co/d/5hW5gBe

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, instead of relying on the traditional V-Model based on the waterfall approach.

In this book, you’ll find valuable information to help you develop software that’s audit-ready and GxP-compliant for industries such as:

🔬 Pharmaceuticals
🧪 Laboratories
📊 Clinical trials
🧬 Broader life sciences sector

You’ll also find numerous practical tips on how a software development vendor can prepare for a supplier audit conducted by a GxP-regulated company.

📘 Discover it all in the book:
👉 Get your copy here

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#GxP #SoftwareValidation #FDACompliance #Annex11 #AgileDevelopment #PharmaSoftware #ClinicalTrials #LifeSciences #SupplierAudit #CFRPart11

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