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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
In today's landscape, businesses must adopt advanced manufacturing IT to enhance their production efficiency. Felten's PILOT:MES, a Manufacturing Execution System (MES), seamlessly combines optimization, quality, and energy management within a cutting-edge platform, enabling production to achieve unparalleled flexibility while ensuring that business processes are fully integrated. The pharmaceutical sector, in particular, faces mounting competitive and profit pressures, exacerbated by ongoing reforms in the healthcare system, which necessitate a concentrated effort to reduce costs in production. In Germany, over seventy-five percent of consumers prioritize a polished appearance, highlighting the importance of quality in the market. However, this emphasis on aesthetics coincides with intense competition that demands rapid adaptation and a steady stream of innovative product ideas. As a result, the production industry is compelled to maintain a high level of flexibility while also streamlining processes to be more cost-effective, which is essential for sustained success. Ultimately, the ability to balance these demands will be crucial for companies aiming to thrive in such a dynamic environment.
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
FELTEN
Founded
1990
Country
Germany
Website
www.felten-group.com/en
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
Manufacturing Execution
Document Management
Forecasting
Quality Control
Quote Management
Resource Management
Supplier Management
Supply Chain Management
Traceability