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Description

Nova-Cleaning Validation software plays a crucial role in bolstering product integrity by effectively managing modifications and evaluating the risks linked to cross-contamination and product impurities in an ever-changing production landscape. It systematically reviews all alterations related to methods, APIs, products, equipment, and family groups to uphold product integrity and ensure adherence to regulatory standards. Furthermore, Nova-Cleaning Validation adheres to the guidelines set forth in 21 CFR Part 11 and EU Annex 11. The system employs a risk-based strategy and is meticulously crafted in accordance with PDA Technical Reports 29 and 49, ISPE MaPP, and 21 CFR Part 211.67, making it a reliable choice for quality assurance in pharmaceutical manufacturing. This comprehensive approach not only safeguards product quality but also enhances the overall efficiency of the production process.

Description

OpsTrakker is the digital platform to kickstart your digital transformation. OpsTrakker replaces manual forms, use-logs and spreadsheets with mobile apps that leverage real-time electronic information to improve manufacturing operations. The current digital solutions include equipment logbooks (logbooks), forms and checklists as well as equipment tracking tools for the pharmaceutical, biotech, and life sciences industries. OpsTrakker bridges between paper-based and full-feature MES solutions. It can eliminate all paper from your shop floor. OpsTrakker's mobile apps are designed to address specific needs and provide cost-effective manufacturing operations management functionality. OpsTrakker allows you to quickly deploy on any device or system. You can create site-specific features and have a user-friendly interface to make it easy to meet your production needs.

API Access

Has API

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

SAP Store

Integrations

SAP Store

Pricing Details

No price information available.
Free Trial
Free Version

Pricing Details

No price information available.
Free Trial
Free Version

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Vendor Details

Company Name

Novatek International

Founded

1996

Country

Canada

Website

www.ntint.com

Vendor Details

Company Name

Enhanced Information Solutions

Founded

1994

Country

United States

Website

opstrakker.com

Product Features

Manufacturing

Accounting Integration
ERP
MES
MRP
Maintenance Management
Purchase Order Management
Quality Management
Quotes/Estimates
Reporting/Analytics
Safety Management
Shipping Management

Product Features

Forms Automation

Approval Process Control
Archiving & Retention
Collaboration
Document Indexing
Drag & Drop
Full Text Search
Remote Document Access
Rules-Based Workflow
Text Editing
Version Control

Industrial IoT

Condition Monitoring
Data Visualization
Factory Data Analytics
Machine Learning
Machine Workflow Creation
Predictive Maintenance
Production Line / Factory Insights
Real-Time Monitoring
Reporting / Analytics
Smart Alerts / Notifications

Logbook

Asset Tracking
Audit Trails
Data Search
Employee Time Clock
For Drivers
For Pilots
User Access Permissions
Violation Tracking

Manufacturing

Accounting Integration
ERP
MES
MRP
Maintenance Management
Purchase Order Management
Quality Management
Quotes/Estimates
Reporting/Analytics
Safety Management
Shipping Management

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