WHY QUALIFICATION
Reliable quality right up to the final inspection.
Following assembly and commissioning, extensive testing is carried out and documented in the IQ/OQ qualifications. These are mandatory in the pharmaceutical and medical industries and ensure that all processes comply with GMP guidelines.
Our structured qualification gives you the assurance that your system will pass every government and customer audit.
QUALIFICATION PHASES
From FAT to PQ
Each phase is clearly defined, fully documented, and ensures the regulatory compliance of your system.
FAT
FACTORY ACCEPTANCE TEST
Comprehensive functional testing of the system before delivery at our factory. Your system is tested under real-world conditions and approved by you – before it leaves your premises.
IQ
INSTALLATION QUALIFICATION
Documented proof that the system was installed correctly and that all components meet specifications. Testing of hardware, cabling, and network connectivity.
OQ
OPERATIONAL QUALIFICATION
Verification that all system functions operate correctly within the defined operating parameters. Testing of all alarms, limit values, interfaces, and user roles.
PQ
PERFORMANCE QUALIFICATION
Proof that the system operates reliably and reproducibly under real production conditions. Long-term tests under normal operating conditions.
DOCUMENTATION
Seamless
Qualification documentation
Our documentation and qualification records are structured and detailed, ensuring they can withstand any regulatory or customer audit. All relevant requirements are met and documented in accordance with standards.
If desired, we will support and accompany you before and during an audit and are always available to you with our expertise.
AUDIT SUPPORT
We will accompany you through each Audit
Whether it's a regulatory audit, customer audit or internal review – our experts will support you in the preparation and will be at your side throughout the entire process.
Rely on over 23 years of experience in GMP-compliant qualification and documentation of cleanroom monitoring systems.
OUR QUALITY DEPARTMENT
Four specialized areas for quality
QA - Quality Assurance
Recording and processing customer complaints using 8D reports. Ensuring compliance with all quality standards.
QE - Quality Engineering
Development of new measurement methods and testing procedures. Continuous optimization of qualification processes.
QC - Quality Control
Testing and implementing new measurement methods in daily operations. Ensuring the reproducibility of all tests.
QM - Quality Management
Further development of systems, training, supplier qualifications and management reviews according to ISO 9001.
HEADQUARTERS SWITZERLAND
ACCESSIBILITY
VALI.SYS EGYPT
CERTIFICATES & LINKS
vali.sys ag
Rosengartenstrasse 17b
8608 Bubikon
Switzerland
+41 43 495 92 50
Mon–Thu: 08:00–12:00 / 13:00–17:00
Friday: 08:00–12:00 / 13:00–15:30