"How SDLC Supports 21 CFR Part 11 in Pharma | GAMP 5 & Validation Made Simple"unnamed 3

Описание: 🔬 Welcome to DigitizerX!
In this episode, Ganesh Chandra breaks down the entire Software Development Life Cycle (SDLC) as it applies to the pharmaceutical industry, aligning every phase with 21 CFR Part 11, GAMP 5, and ALCOA+ data integrity principles.

If you're involved in software validation, QA, regulatory affairs, or pharmaceutical IT, this episode is your complete guide to building GxP-compliant systems — from User Requirements to Decommissioning.

🎯 What You’ll Learn:
What is SDLC in a pharma context?

How to write compliant URS, FS, DS documents

Development best practices under GAMP 5

Validation protocols: IQ, OQ, PQ explained

Controlled software release & change control

How to retire systems without risking compliance

The role of 21 CFR Part 11, GAMP 5, and ALCOA+ in pharma software

📌 Key Compliance Concepts Covered:
✔️ 21 CFR Part 11
✔️ GAMP 5 (Risk-Based Validation)
✔️ ALCOA+ Data Integrity
✔️ Electronic Signatures & Audit Trails
✔️ Traceability & Change Control

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PharmaTech

Regulatory Compliance

Digital Transformation

Data Integrity & Validation

📢 Let us know in the comments:
How does your team approach software validation in pharma?