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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
Digital Logbook: Streamlining Room Logs for GMP Compliance. In the pharmaceutical industry, it is essential to document all activities in logbooks to adhere to Good Manufacturing Practice (GMP) standards. Traditional methods, such as handwritten logs or Excel spreadsheets, are often employed, but these can hinder the analysis of data and become prohibitively expensive due to labor-intensive maintenance and security issues. With our solution, you receive a user-friendly, adaptable, and scalable architecture that allows for the digitization of all room logs and forms, effectively capturing activities on the production floor. You can access your data conveniently and securely from anywhere at any time, enhancing both security and quality through the integration of personal digital signatures. Additionally, our system ensures compliance with GMP regulations by providing immutable records, with optional blockchain technology for added security. The process is simple: line operators can log activities or tasks with just a few clicks or taps, while multiple security layers safeguard the integrity of the logbook. Furthermore, customizable workflows align with your specific data entry and template approval processes, making it easier than ever to maintain compliance and efficiency. This modern approach not only simplifies record-keeping but also fosters a culture of accountability in pharmaceutical operations.
API Access
Has API
API Access
Has API
Integrations
No details available.
Integrations
No details available.
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
Supply Chain Wizard
Founded
2014
Country
United States
Website
solutions.supplychainwizard.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
Logbook
Asset Tracking
Audit Trails
Data Search
Employee Time Clock
For Drivers
For Pilots
User Access Permissions
Violation Tracking
OEE
Benchmarking
Cost Tracking
Downtime Tracking
Historical Reporting
Performance Metrics
Quality Control
Real Time Reporting
Root Cause Analysis
Trend Analysis
Work Order Management
Production Scheduling
"What If" Scenarios
Automated Scheduling
Bottleneck Optimization
Capacity Planning
Constraint Scheduling
Job Scheduling
Material Planning
Priority-Based Scheduling
Quality Control
Time Clock
Biometric Recognition
Hourly Employee Tracking
Messaging
Mobile Access
Online Punch Card
Payroll Management
Punch card
Reporting/Analytics
Salaried Employee Tracking
Sick Leave Tracking
Vacation / Leave Tracking
Workstation Tracking