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Description
In the realm of pharmaceutical production, it is crucial to document activities on the shop floor in real-time to maintain quality standards and comply with regulations such as 21 CFR Part 11 and Good Manufacturing Practices (GMPs). Utilizing an automated system guarantees that batch records are free from errors and can be easily accessed, while also allowing for the tracking of batch manufacturing processes. Electronic Batch Record (EBR) software, such as CaliberBRM, replaces traditional paper-based systems, thereby mitigating associated risks and ensuring the integrity of data and product quality. In industries that are highly regulated, particularly in life sciences, the real-time recording of the 4Ms becomes a necessity as it streamlines business processes. Transitioning to digital batch production records can significantly reduce both time and effort. The EBR system provides comprehensive oversight of the 4Ms, enabling organizations to minimize inventory waste, optimize workforce allocation, manage instruments effectively, and shorten review cycles, all of which lead to decreased operational costs. Furthermore, Quality Review Management (QRM) emphasizes the importance of exception-based reviews to expedite batch releases, enhancing overall efficiency. By implementing these modern solutions, companies can create a more agile and responsive manufacturing environment.
Description
SG Systems Global offers traceability and manufacturing solutions for regulated and non-regulated industries, integrating with ERP and MES platforms to boost efficiency and ensure product quality.
Key Modules:
* Electronic Batch Records (EBRs): Digital records to meet 21 CFR Part 11 and GMP compliance, reducing manual errors.
* Formula Control: Ensures accurate ingredient measurement and consistency across batches.
* Batch Control: Tracks production in real time, enabling lot validation and recall management.
* Warehouse Management System (WMS): Manages inventory with barcode scanning and real-time stock updates.
* Production Scheduling: Automates workflows, assigns tasks, and generates performance reports.
These solutions streamline processes, enhance compliance, and support scalable growth for manufacturers.
API Access
Has API
API Access
Has API
Integrations
CaliberPulse
CalibereLog
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
Caliber Technologies
Founded
2001
Country
India
Website
caliberuniversal.com/solutions/batch-record-management/
Vendor Details
Company Name
SG Systems Global
Country
United States
Website
sgsystemsglobal.com
Product Features
Manufacturing
Accounting Integration
ERP
MES
MRP
Maintenance Management
Purchase Order Management
Quality Management
Quotes/Estimates
Reporting/Analytics
Safety Management
Shipping Management
Manufacturing Execution
Document Management
Forecasting
Quality Control
Quote Management
Resource Management
Supplier Management
Supply Chain Management
Traceability
Product Features
Food Manufacturing
Compliance
ERP
Food Safety
Food Traceability
Ingredient Management
Production Scheduling
Quality Management
Recall Tracking
Recipe Management
Seasonal Demand Forecasting
Supply Chain Management
Food Traceability
CRM
Order Management
Product Lifecycle Management
Production Management
Quality Control
Recall Management
Recipe Management
Traceability
Traceback & Traceforward