Pharmaceutical Quality Software for Regulated Operations
Novatek International builds specialized software for pharmaceutical, biotech, and regulated healthcare manufacturers — environmental monitoring, stability, water and utility monitoring, laboratory testing, and quality systems. Use one solution on its own, or connect several.
Choose the Solution That Fits Your Workflow
Novatek’s most-requested solutions support the regulated workflows where accuracy, traceability, and audit readiness matter most.
Environmental Monitoring Software
Purpose-built for microbiological environmental monitoring, not an afterthought added to LIMS. Run the complete regulated EM workflow in one system: sampling plans and scheduling, data collection, excursion management, preventive, routine and investigational trending, and reporting. Supports the holistic contamination control strategy expectations of EU GMP Annex 1.
Stability Management Software
Manage the full stability study lifecycle, protocols and pull schedules, storage conditions, testing, statistical analysis, and shelf-life evaluation. Runs as a standalone stability system, or alongside Novatek’s laboratory and quality solutions.
Water & Utility Monitoring Software
Monitor and manage utility system sampling and testing data, trending, risk-area visibility, and specification change control across GMP environments. Perfect for purified water, WFI, CDA, compressed gas monitoring. Operates independently, or connected to Novatek Environmental Monitoring.
Our Product Suite
Choose a single specialized application, or connect several across quality processes.
Monitor, manage, and document contamination control across sterile and non-sterile environments, supporting sterility assurance programs and EU GMP Annex 1 expectations.
Laboratory information management and quality execution for product testing, chemistry, raw materials, stability, and regulated laboratory workflows.
Documentation, quality events, investigations, training, and corrective actions across regulated operations.
Tools supporting laboratory operations, records, maintenance, and controlled workflows.
Purpose-Built Solutions. Connected Where You Need Them.
Novatek solutions can be deployed individually or connected across QC chemistry, QC micro, and quality assurance. Start with the applications you need most, then integrate related systems, instruments, and processes as your requirements evolve.
Lower Implementation Risk
Quality, validation, IT, and operations teams each need different assurances before a system goes live. Novatek supports all four.
Case Study
Sanofi Genzyme Digitizes Environmental & Utility Monitoring with Novatek
Novatek International helped Sanofi Genzyme's Lyon, France manufacturing site replace manual, paper-based environmental and utility monitoring with an industry-focused digital solution — improving dat…
Resources for Pharma Quality and Compliance Teams
Practical guidance on environmental monitoring, contamination control, stability, and selecting regulated quality software.
Ready to Discuss Your Quality Software Requirements?
Tell us the workflow you need to improve, environmental monitoring, contamination control, stability, water and utility, laboratory, or quality systems, and we’ll show you which Novatek solutions fit.