Qualification & Validation

We provide comprehensive Qualification & Validation support for pharmaceutical, biotechnology and healthcare facilities, combining deep GMP knowledge with ALLOVIS’ engineering, testing, instrumentation and digital capabilities. Our core specialization is the qualification of pharmaceutical isolators, cleanrooms and critical controlled environments, where regulatory requirements, engineering performance and contamination control must work together. We support our clients throughout the qualification lifecycle, from initial risk assessment and qualification strategy to protocol development, execution, deviation management and final reporting. Our multidisciplinary approach allows us to go beyond traditional qualification activities. ALLOVIS combines pharmaceutical quality and validation expertise with CFD, fluid dynamics, advanced instrumentation, data acquisition, automation and software capabilities, enabling us to investigate system behaviour, generate reliable experimental data and address complex technical issues identified during qualification. For cleanrooms and controlled environments, we support qualification activities including environmental and physical parameter verification, airflow and pressure assessment, temperature and humidity mapping, recovery testing, HEPA filter integrity testing, air velocity and airflow volume measurements, particle monitoring and airflow visualization / smoke studies, according to the applicable qualification strategy and regulatory requirements. We have particular expertise in isolator and barrier-system qualification, supporting pharmaceutical companies and equipment manufacturers in demonstrating that these critical systems perform as intended. Our activities can cover airflow patterns, pressure regimes, HEPA filtration, environmental conditions, leak tightness, decontamination-cycle qualification, glove integrity strategy, smoke studies and other critical performance parameters, depending on the system and its intended use. Our engineering capabilities become particularly valuable when qualification results reveal unexpected behaviour. Through CFD simulations, dedicated measurement campaigns, sensor systems and data analysis, we can help investigate airflow anomalies, pressure imbalances, temperature distribution, ventilation performance and other engineering challenges rather than simply documenting a failed acceptance criterion. We can also support the qualification of a broader range of pharmaceutical equipment, utilities and critical systems, developing risk-based approaches and tailored qualification strategies according to system criticality and intended use. Where computerized or automated systems form part of the equipment or process, our software and digital expertise can complement the qualification strategy, supporting the assessment of computerized functions, data flows, system interfaces and data integrity requirements within the applicable GxP framework. Our support can cover the complete qualification lifecycle — from URS and Design Qualification through IQ, OQ and PQ — as well as requalification, changes, troubleshooting and qualification following equipment upgrades or facility modifications. We do not see qualification as a documentation exercise. We use engineering, science and data to demonstrate that critical systems perform as intended and remain in a state of control.