Thinking about implementing an eBMR system in your facility? That’s a smart move — but don’t skip the most important part: validation.
Without proper validation, your system could be considered non-compliant by regulatory authorities like the FDA or CDSCO. But the good news? With a GAMP5-compliant approach, you can validate your eBMR system with structure and confidence.
Let’s walk through it, step by step.
What is GAMP5, and Why Does It Matter?
GAMP5 stands for Good Automated Manufacturing Practice, a globally recognized guideline for validating computerized systems in pharma. Following it shows regulators that your system works as intended and protects data integrity.
And yes — it’s a must when you’re working with electronic Batch Manufacturing Records (eBMR).
Step-by-Step eBMR System Validation
Start with a Risk-Based Approach
Focus on features that directly impact product quality and patient safety. Not every function in your eBMR system needs the same level of validation. Let risk guide your priorities.
Define the URS (User Requirements Specification)
Clearly list what you need the system to do — from batch creation and signature control to data capture and audit trails. This document is your foundation.
Perform IQ, OQ, PQ Testing
These are your core validation steps:
- IQ (Installation Qualification): Is the system installed correctly?
- OQ (Operational Qualification): Does it work as expected under normal conditions?
- PQ (Performance Qualification): Does it consistently perform in your real-world environment?
Each test should be documented and traceable.
Document Everything
From protocols to test results and deviation logs — keep it all well-organized. This proves that validation was thorough and intentional.
Plan for Continuous Review
Validation isn’t a one-time event. You’ll need periodic reviews, especially when you upgrade or change your system. Don’t forget to update your validation documents when changes occur.
Pro Tip: Align Your SOPs
Don’t forget to update your Standard Operating Procedures (SOPs) to reflect your validated eBMR workflows. This ensures your team knows exactly what to do — and keeps you audit-ready.
For guidance on writing compliant SOPs, you might find ISPE’s GAMP5 resources helpful.
Validating your eBMR system isn’t just about ticking a box — it’s about building trust in your process. By following a GAMP5-compliant validation plan, you make sure your data is reliable, your system is audit-ready, and your batches are always compliant.
It takes effort, yes — but the confidence and peace of mind? Totally worth it.