Validation of medico automation

Validation of medico automation – when QA is part of the project from the start

 

In medico projects, validation is not a final phase; it is a prerequisite for success.
At Kilde, we work with structured, GMP-based validation integrated throughout the entire project lifecycle. Requirements, risk assessments, design and testing are linked in a cohesive documentation structure that supports FAT, SAT and subsequent IQ/OQ.

 

This provides clear benefits for QA and Validation:

• Clear traceability between URS, risk, design and testing.
• Documentation at a level that can be reused directly for IQ/OQ.
• Fewer deviations and less rework during handover.
• More predictable projects and shorter time-to-compliance.

 

The result is a reduced workload for the QA organization and a smoother transition from project to production.

 

When validation is built in from the start, compliance becomes an accelerator rather than a bottleneck.