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NOVA-LIMS

Sample tracking, data collection, and real-time reporting for pharmaceutical and biotech labs with 21 CFR Part 11 compliance.

Overview

NOVA-LIMS is a Laboratory Information Management System developed by Novatek International, designed to help pharmaceutical and biotechnology organizations streamline laboratory operations, reduce manual workloads, and accelerate product time to market while maintaining regulatory compliance. By centralizing data and automating key processes, NOVA-LIMS enables accountability and reliability across inter-related and interdependent departments, providing seamless integration between laboratory testing, scheduling, data collection, and real-time reporting.

As an out-of-the-box solution, NOVA-LIMS is easily tailored to meet specific organizational requirements. Its modular, process-driven architecture is built on a foundational workload management framework with instrument interfacing capabilities, and it is fully 21 CFR Part 11 compliant. A unique feature of NOVA-LIMS is its interface for seamless communication between the LIMS and Quality Management Systems, positioning it at the forefront of process harmonization and data centralization.

Key Features and Functions

  • Centralized database accessible across all sites
  • Easy workflow configuration to match organizational processes
  • Efficient scheduling including sample plans
  • Tracks cost and testing time
  • User-defined fields for flexible data capture
  • Data integrity and security meeting 21 CFR Part 11 requirements
  • Minimizes problems caused by human error
  • Inventory tracking with automatic order notifications
  • Modern, easy-to-use equipment interfacing for results and calibration data
  • Real-time data entry with barcode support
  • Rapid implementation and validation

Paperless and Integrated Laboratory Environment

  • Creates a complete, paperless integration of data by interfacing with lab equipment and incorporating statistical packages
  • Electronic worksheets enable faster data entry, improved efficiency, and reduced manual error
  • Seamless tracking without the need to print anything beyond barcodes
  • Compatible with Oracle and SQL databases
  • Embedded toolset supports day-to-day tasks with reduced risk of manual error
  • Worker productivity improvements of up to 60% have been demonstrated, delivering a strong return on investment

Modular Design and Scalability

  • Modular architecture allows organizations to purchase only the modules that address current requirements
  • Additional modules can be activated as the organization grows, with minimal integration and validation effort
  • Each module can be used independently or as part of the broader solution
  • Meets up to 95% of customer requirements out of the box, with client-specific configuration available
  • Can expand into a full Quality Execution LIMS System through integration with Novatek's suite of products, including Environmental Monitoring software, Stability Program, and Raw Material and Finished Product Analyzer

NOVA-LIMS is compatible with Oracle and SQL databases and integrates with the broader Novatek product suite, enabling organizations to build a comprehensive quality execution environment. Its rapid implementation approach, combined with its scalable modular design, makes it a cost-effective long-term solution for laboratory data management across the life sciences industry.

Meta

Domain
Lab Informatics & Operations
Subdomain
Laboratory Information Management System (LIMS)
Software type(s)
Workflow Automation
Deployment type(s)
On-Premise
Industry vertical(s)
PharmaBiotech
Development stage(s)
Preclinical / Pre-MarketManufacturing
Target user(s)
Bench Scientist / Lab TechnicianLab Manager / Core Facility ManagerQA / Regulatory Affairs
Compliance standard(s)
21 CFR Part 11GxP