01
Start with intended use
Define what the configured system must support and what evidence is needed.
RESOURCES · PRACTICAL GUIDANCE
A Practical Approach to QMS Validation
Understand risk-based qualification and lifecycle management for regulated computerised systems.
PRACTICAL APPROACH
Steps to consider
02
Apply a risk-based approach
Prioritise activities by risk to product quality, patient safety and data integrity.
03
Build validation into implementation
Align design, configuration, testing and documentation from the outset.
04
Maintain the validated state
Assess changes, upgrades and configuration updates throughout the lifecycle.
05
Use available supporting services
Connect platform documentation and implementation support to the qualification strategy.
RELATED K2C CONTENT
Connect guidance to delivery
Each organisation should confirm scope and intended use before selecting modules.
Discuss your quality strategy
We can explore how these principles apply to the processes you need to govern.
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