Average Ratings 0 Ratings
Average Ratings 0 Ratings
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
Vimachem’s Pharma 4.0 MES platform stands out as a versatile and entirely modular manufacturing execution system, leveraging the principles of AI and IIoT to facilitate digital transformation in the pharmaceutical and biopharmaceutical sectors. Tailored for environments adhering to cGMP regulations and 21 CFR Part 11 standards, this system provides instantaneous, contextually relevant feedback on the production floor, effectively linking devices, machinery, and personnel to streamline operations from the initial planning stages to the final product delivery, all while upholding strict quality requirements. The platform ensures that information circulates effortlessly throughout the organization, supplying the appropriate data to the relevant teams precisely when needed. By utilizing AI-generated insights, it enhances production efficiency and overall equipment effectiveness (OEE) from the outset, while secure integrations consolidate all plant data into user-friendly dashboards. With the elimination of paperwork, the prevention of compliance issues, and the facilitation of scalable automation, Vimachem enables life-science manufacturers to minimize manual labor, elevate operational performance, and expedite the introduction of essential therapies to the market. Ultimately, this innovative solution not only propels efficiency but also supports the evolving needs of the pharmaceutical industry.
API Access
Has API
No
API Access
Has API
No
Integrations
CaliberPulse
No
CalibereLog
No
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Customer Support
Business Hours
Yes
Live Rep (24/7)
No
Online Support
Yes
Customer Support
Business Hours
No
Live Rep (24/7)
No
Online Support
Yes
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
Yes
In Person
Yes
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
Yes
In Person
No
Vendor Details
Company Name
Caliber Technologies
Founded
2001
Country
India
Website
caliberuniversal.com/solutions/batch-record-management/
Vendor Details
Company Name
Vimachem
Founded
2014
Country
United States
Website
www.vimachem.com
Product Features
Manufacturing
Accounting Integration
No
ERP
No
MES
No
MRP
No
Maintenance Management
No
Purchase Order Management
No
Quality Management
Yes
Quotes/Estimates
No
Reporting/Analytics
Yes
Safety Management
No
Shipping Management
No
Manufacturing Execution
Document Management
No
Forecasting
No
Quality Control
Yes
Quote Management
No
Resource Management
No
Supplier Management
No
Supply Chain Management
No
Traceability
No
Product Features
Manufacturing Execution
Document Management
No
Forecasting
No
Quality Control
No
Quote Management
No
Resource Management
No
Supplier Management
No
Supply Chain Management
No
Traceability
No