Industry Brief
8 Tips for Compliant and Quick Software Validation
You'll learn:
- How MasterControl helps customers validate in 45 minutes.
- How testing and documentation from your vendor can reduce your validation burden.
- How the FDA’s recommendations give you flexibility in GxP software validation.
About This Asset
Computer system validation (CSV) tends to be a sore spot. That’s not very surprising since some professionals spend months on validation. There’s no regulatory requirement for GxP software validation to take that long. In fact, following the guidance from the U.S. Food and Drug Administration (FDA), companies can validate in a matter of hours for their initial implementation and a matter of minutes for upgrades.
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Take the Pain Out of Validation
Don’t Redo Work
Software providers validate their own products and have a better understanding of what their software can do. There’s no need for a company to redo all that work if they can leverage their provider’s documentation.
Focus on Intended Use
Validation shouldn’t focus on each individual feature contained in a software. What matters is how you use the software. Taking a holistic look at your intended use lets you focus your efforts on ensuring the software works for you.
Use a Risk-Based Approach
When it comes to validating in a life sciences environment, companies need to focus on patient safety and product quality. The same applies when validating. If a feature won't have an effect on those things, it doesn’t merit the same level of criticality as features that do.
Simplify computer system validation.
Learn how to stop using old approaches to validation and make your life easier.
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