Loading…
PHARMACEUTICAL QUALITY SOFTWARE SINCE 1996
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.
Trusted by Quality Teams Worldwide
30 years of global installations
Novatek has delivered quality software to regulated pharmaceutical operations since 1996.
Built for sterile and non-sterile manufacturing
Supporting aseptic operations, sterility assurance teams, and non-sterile manufacturers across pharmaceutical, biotech, and healthcare.
Implementation and validation support
Deployment, training, integrations, equipment interfacing, and validation documentation.
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.
Explore Environmental Monitoring Software
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.
Explore Stability Management Software
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.
Explore Water & Utility Monitoring Software
Our Product Suite
Software Across the Pharmaceutical Quality Lifecycle
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.
Nova-QMS
Quality Management System Software
Document
Change Control
Training
CAPA
Audit
Investigations
Deviation
Complaints
Tools supporting laboratory operations, records, maintenance, and controlled workflows.
Connected where you need it
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.
Standalone or connected deployments
Integration with existing systems and equipment
Workflow visibility across regulated operations
Built for regulated implementation
Lower Implementation Risk
Quality, validation, IT, and operations teams each need different assurances before a system goes live. Novatek supports all four.
Regulated-workflow experience in pharmaceutical and biotech since 1996
Solutions designed to support regulated GxP workflows, with product-specific capabilities for requirements such as 21 CFR Part 11 and EU GMP Annex 11
Contamination control capabilities aligned to EU GMP Annex 1 regulations
Validation gap analysis, IQ/OQ execution, and supplied validation documentation
Project-managed implementation, third-party and equipment integration, structured training, and global technical support
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…
Read the case study
Resources for Pharma Quality and Compliance Teams
Practical guidance on environmental monitoring, contamination control, stability, and selecting regulated quality software.
Why Is Digitalization Becoming Essential in Pharma?ArticlesDigitized vs. Digitalized: Understanding the Core DifferenceNewsWhy Statistics Matter in Stability StudiesArticles
Upcoming Events
SEP 22 – 23
KENX – AI in GxP Canada
DoubleTree by Hilton Toronto Downtown, 108 Chestnut Street Toronto, Ontario M5G1R3
SEP 22 – 23
PDA APAC – Advanced Parenteral Therapeutics & Quality Summit 2026
ILLUME Hotel, Taipei in Taipei, Taiwan
SEP 30
PMF – Pharmaceutical Microbiology Forum 2026
Pharmaceutical Microbiology Forum, Cambria, 219 S. Broad Street, Philadelphia, PA 19103
Ready to Discuss Your Quality Software Requirements?
Tell us the workflow you need to solve, environmental monitoring, contamination control, stability, water and utility, laboratory, or quality systems, and we’ll show you which Novatek solutions fit.