Novatek International

Novatek International is a global provider of regulatory-compliant, process-driven software solutions purpose-built for the pharmaceutical, biotech, and broader healthcare industries. Founded in 1996, the company has accumulated 30 years of successful global installations and an extensive base of regulatory knowledge, helping organizations achieve and maintain compliance with regulatory guidelines while improving patient safety and product quality.

Novatek's mission centers on reducing the risks associated with pharmaceutical manufacturing through innovative, business-ready software that goes beyond traditional LIMS to deliver total enterprise-wide automation. Their portfolio of specialized modules is designed to manage all aspects of a quality environment with less effort and time, offering rapid return on investment across worldwide deployments.

Contamination Control Solutions

• NOVA-CVM (Cleaning Validation Management Software): Manages and streamlines the cleaning validation process to ensure compliance and reduce contamination risk.
• Novatek Environmental Monitoring: Comprehensive environmental monitoring management software for tracking and controlling facility environments.
• Novatek Environmental Monitoring Mobile: Enables real-time data capturing to secure and support the environmental monitoring sampling process in the field.
• Water & Utility Monitoring: Dedicated software for managing water and utility monitoring programs within regulated facilities.
• Novatek Disease Control & Hygiene Software: A solution focused on saving lives through better data management related to disease control and hygiene monitoring.

Quality Execution LIMS

• NOVA-LIMS (Laboratory Information Management System): A full-featured LIMS designed to manage laboratory workflows, data, and compliance requirements within pharmaceutical and biotech environments.
• NOVA-STABILITY (Stability Management System Software): Manages stability testing programs and associated data to support regulatory submissions and product lifecycle management.
• Material Management: Includes a Raw Material Analyzer and Finished Product Analyzer to oversee incoming and outgoing material quality and compliance.

Quality Process Solutions

• NOVA-QMS (Quality Management System Software): Supports the management of quality processes, deviations, CAPAs, and other quality system elements across the enterprise.
• NOVA-CPM (Calibration & Preventive Maintenance Management Software): Manages calibration schedules and preventive maintenance activities to ensure equipment compliance and uptime.
• Validation Management Software: Provides tools to plan, execute, and document validation activities in line with regulatory requirements.

Additional Solutions

• Automated Proofreader: Automated proofreading software to support document accuracy and quality control.
• Consumable Inventory Management Software: Tracks and manages laboratory consumables to prevent shortages and maintain traceability.
• Column Organizer Management Software: Organizes and tracks chromatography columns and related laboratory assets.
• NOVA-INNOVATE (Innovation Management Software): Supports the management of innovation initiatives within the organization.
• NOVA-Screen Capture: Provides quick and automated screen capturing capabilities to support documentation and compliance workflows.

Company Experience and Core Goals

• 30 years of successful global installations with worldwide reach and global regulatory compliance expertise.
• Committed to producing innovative, business-ready software solutions that address real industry needs and deliver rapid return on investment.
• Core goals include improving patient safety, reducing risk in pharmaceutical manufacturing, and improving overall product quality.
• Worldwide network of representatives available to support clients across global markets.

Novatek International actively participates in industry events such as PDA Week and regional PDA conferences, and regularly publishes whitepapers and technical content — including topics such as stability testing statistics and digital transformation — reflecting their ongoing commitment to advancing knowledge and best practices across the life sciences sector.