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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 CAI Mar-Kov Essentials?

Mar-Kov ERP is an integrated enterprise resource planning and manufacturing execution platform developed by CAI Software for companies operating in batch and process manufacturing environments. The software provides centralized management of production activities, inventory, product formulations, quality assurance, regulatory documentation, material planning, and financial information. Its manufacturing execution system guides production operators through defined procedures using barcode checkpoints, electronic instructions, integrated weighing scales, and configurable approval requirements. Electronic batch records automatically capture production activities, measurements, ingredient usage, equipment information, operator signatures, and time-stamped manufacturing data. Formulation management capabilities enable businesses to create and maintain master recipes, track revisions, control formula access, manage approvals, and automatically scale ingredient quantities for different batch sizes. The warehouse management system provides barcode-based inventory tracking, container and lot identification, warehouse location management, cycle counting, expiration monitoring, and FIFO/FEFO stock rotation. Quality management features support raw material inspections, laboratory testing, quarantine and release workflows, production deviations, rework instructions, and automated Certificates of Analysis. Regulatory compliance capabilities include electronic audit trails, digital signatures, supplier certification tracking, allergen controls, and documentation supporting FDA, GMP, GFSI, and 21 CFR Part 11 requirements. Automated material requirements planning analyzes open orders, sales forecasts, inventory quantities, production capacity, and supplier lead times to generate purchasing recommendations and manufacturing schedules.

Media

Media

Integrations Supported

Integrations Supported

JD Edwards EnterpriseOne
QuickBooks Online
SAP ERP
Shopify
WooCommerce

API Availability

API Availability

Pricing Information

Pricing not provided
Free Trial Offered?

Pricing Information

$200/month
Free Trial Offered?

Supported Platforms

SaaS
Windows
Mac

Supported Platforms

SaaS
Android
Windows

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour 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

CAI Software

Date Founded

1978

Company Location

United States

Company Website

caisoft.com/product/mar-kov-erp/

Categories and Features

Manufacturing

Quality Management
Reporting/Analytics

Categories and Features

Cannabis

Business Management
Compliance Tracking
Delivery Management
ERP
For Hemp & CBD
Inventory Management / Control
Lab Testing
Manufacturing
Reporting / Analytics
Sales Tracking
Supplier Management
Supply Chain Management
Toll Processing
Traceability

Capacity Planning

Not specified

Chemical

Certificates of Analysis
ISO Management
Inventory Management
Reporting & Statistics
Samples Tracking
Traceability

Food Traceability

Order Management
Production Management
Quality Control
Recall Management
Recipe Management
Traceability
Traceback & Traceforward

Inventory Control

Allocation
Barcoding
Cost Tracking
Forecasting
Item Management
Order Management
Procurement Management
Reorder Management
Serial Number Tracking
Supplier Management

Manufacturing Execution

Document Management
Forecasting
Quality Control
Quote Management
Resource Management
Supplier Management
Supply Chain Management
Traceability

Process Manufacturing

Not specified

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