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Ratings and Reviews 0 Ratings
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What is Nova-Cleaning Validation?
Nova-Cleaning Validation software is essential for enhancing product integrity by adeptly handling changes and assessing the risks related to cross-contamination and impurities in a dynamic production environment. It diligently examines every modification concerning methods, APIs, products, equipment, and family groups to maintain product integrity while ensuring compliance with regulatory requirements. In addition, Nova-Cleaning Validation complies with the stipulations outlined in 21 CFR Part 11 and EU Annex 11, which further solidifies its reliability. The system utilizes a risk-based approach and is thoroughly designed in accordance with PDA Technical Reports 29 and 49, ISPE MaPP, and 21 CFR Part 211.67, positioning it as a trusted option for quality assurance in the pharmaceutical sector. This all-encompassing strategy not only protects product quality but also boosts the overall efficiency of the manufacturing process, ultimately leading to more reliable outcomes for stakeholders. By continuously adapting to new challenges in the industry, it ensures that the highest standards of quality are consistently met.
What is Luminata?
Luminata enables the consolidation of all your analytical, chemical, and process data into a single platform. This software for decision support facilitates collaboration among pharmaceutical development teams, eliminating the necessity for spreadsheets or incompatible file formats. Its applications extend to process control, forced degradation, batch genealogy, and the characterization of composite materials, enhancing efficiency and accuracy in research and development. By streamlining these processes, Luminata empowers teams to focus on innovation and results.
Integrations Supported
Spectrus Processor
API Availability
Has API
API Availability
Has API
Pricing Information
Pricing not provided.
Free Trial Offered?
Free Version
Pricing Information
Pricing not provided.
Free Trial Offered?
Free Version
Supported Platforms
SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux
Supported Platforms
SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux
Customer Service / Support
Standard Support
24 Hour Support
Web-Based Support
Customer Service / Support
Standard Support
24 Hour Support
Web-Based Support
Training Options
Documentation Hub
Webinars
Online Training
On-Site Training
Training Options
Documentation Hub
Webinars
Online Training
On-Site Training
Company Facts
Organization Name
Novatek International
Date Founded
1996
Company Location
Canada
Company Website
www.ntint.com
Company Facts
Organization Name
ACD/Labs
Date Founded
1994
Company Location
Canada
Company Website
www.acdlabs.com/products/spectrus-platform/luminata/
Categories and Features
Manufacturing
Accounting Integration
ERP
MES
MRP
Maintenance Management
Purchase Order Management
Quality Management
Quotes/Estimates
Reporting/Analytics
Safety Management
Shipping Management
Categories and Features
Decision Support
Application Development
Budgeting & Forecasting
Data Analysis
Decision Tree Analysis
Monte Carlo Simulation
Performance Metrics
Rules-Based Workflow
Sensitivity Analysis
Thematic Mapping
Version Control