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Clara Fargo
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I have finalised the demo for the ICH-GCP E6 R3 refresher course. Overall, I liked the content and the interface. I also want to thank Whitehall Train...
Computerised Systems, Data Integrity & Validation Learning Path
4.6
★★★★★
97% Recommended
Updated 2025
18 hours
185 active users
18 points
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Each course includes:
Fully compliant
This learning path is aligned with GAMP 5, EU GMP Annex 11 and Annex 22, and FDA 21 CFR Part 11 — providing comprehensive compliance coverage for the topics covered. Learners receive Continuing Professional Development (CPD) Points awarded by the Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom.
Certified
All learners who pass the final exam receive a uniquely numbered, personal certificate to demonstrate their subject knowledge. Since the questions are picked randomly from a database, re-sitting the exam does not mean taking the same questions again and again.
Affordable
Our cost-effective prices represent excellent value. You can easily pay up to ten-times more for face-to-face training. We can also offer generous group discounts on larger purchases.
Time-saving
Our administration system makes it incredibly quick and simple to allocate licences to multiple learners. Learners save time too by choosing when and where they complete the training.
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About
The Computerised Systems, Data Integrity & Validation Learning Path equips professionals with the knowledge to validate computerised systems, ensure data integrity, and apply AI compliance principles within GxP environments. It covers GAMP 5, EU GMP Annex 11, Annex 22 AI compliance, and 21 CFR Part 11 electronic records requirements.
Participants will develop the skills to validate systems, ensure data integrity throughout the data lifecycle, and support the responsible use of AI in GxP-regulated operations.
Courses Included
Core principles of computer system validation, data integrity, and GAMP 5 risk-based validation lifecycle.
3 hours
2 pointsEU GMP Annex 11 requirements for computerised systems and preparing for data integrity audits.
3 hours2 pointsRegulatory expectations under EU GMP Annex 22 for the use of AI in pharmaceutical manufacturing and quality.
3 hours2 pointsValidating AI-enabled systems within a GAMP 5 and GxP compliance framework.
3 hours2 points
Requirements for electronic records and electronic signatures under FDA 21 CFR Part 11.
2 hours3 pointsEquipment and process qualification principles (IQ/OQ/PQ) supporting validated GxP operations.
1 hours2 pointsOur Certified Customers
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Frequently Asked Questions
- Computer System Validation (CSV) and IT quality professionals
- QA professionals responsible for data integrity oversight
- Validation engineers and qualification specialists
- Professionals implementing or auditing AI-enabled GxP systems
Upon completion of this learning path, participants will be able to validate computerised systems using a GAMP 5 approach, apply EU GMP Annex 11 and Annex 22 requirements, ensure compliance with FDA 21 CFR Part 11, and support qualification and validation activities across GxP systems.
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