Validation Services: Mapping, System and Equipment Validation
Validation solutions compliant with WHO TRS 961 Annex 9 and ISO 14644 standards
We manage validation processes critical for pharmaceutical, food and healthcare sectors under the guidance of WHO TRS 961 Annex 9 and Good Distribution Practices (GDP).
Temperature and Humidity Mapping
Detection of critical hot/cold spots in warehouses and depots, seasonal variation analysis
Cold chain storage validation
Seasonal (summer/winter) mapping studies
Identification of critical hot/cold spots
7-14 days continuous monitoring and recording
Vehicle and Box Validation
Performance tests with loading scenarios (empty/full) for refrigerated vehicles and shipping boxes
Refrigerated vehicle validation
Passive cooling box performance testing
Empty, semi-loaded and full load scenarios
Route-based temperature profile analysis
Computer System Validation (CSV)
Verification of computerized systems according to GAMP 5 protocols
GAMP 5 (Good Automated Manufacturing Practice) compliance
IQ, OQ, PQ (Installation, Operational, Performance Qualification)
SCADA, ERP, LIMS software validation
Data integrity verification
Cleanroom Validation (ISO 14644)
Particle counting, airflow measurement and HEPA filter leak tests within ISO 17020 scope
Particle counting and classification (ISO 14644-1)
Airflow velocity and direction measurement
HEPA filter leak test (DOP/PAO test)
Differential pressure measurement
Recovery time testing