Qualification & Validation

For every Phase, the correct Measure

Qualification and validation (Q&V) in a regulated environment are essential prerequisites for a high degree of patient safety, product quality and data integrity.

These points are the center of our focus, from the first to the last life cycle phase. Using targeted placement of risk analysis within the concept and project phases, we achieve a high level of effectiveness pertaining to Q&V measures.

The consistent implementation of the resulting measures, in combination with backtracking of the recognized and judged risks produces a high level of transparency.

Concept Phase

Project Phase

Operation Phase

Prospective or
Retrospective

Retirement Phase