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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.

Media

Media

Integrations Supported

Spectrus Processor

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

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