During validation our certified engineers establish and document that your testing instrument or system accomplishes its intended function. This also involves acceptance of fitness for purpose with end users and operators. All equipment and instruments must meet clearly defined standards for installation, operation and performance.
Dr. Schleuniger Pharmatron supports this process with detailed validation protocols that can be executed by your team or by our trained service engineers:
- Installation qualification (IQ)
- Operational qualification (OQ)
- Performance qualification (PQ)
- Computer system validation (CSV)
Additional documentation for FDS, FAT and SAT can also be carried out by a factory-trained professional. All documents are continuously reviewed and extended to meet additional requirements.