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
Streamline the processes involved in batch records, cleaning, environmental oversight, and inventory control. Enhance the production of advanced therapies using software tailored for Good Manufacturing Practice (GMP). This tool serves as an effective means to unify your workforce towards achieving ‘right-first-time manufacturing’. Eliminate the chaos of scattered paperwork by utilizing a single software solution that facilitates data collection, review and approval workflows, comprehensive reporting, and insightful analytics. Guarantee that your team adheres to the proper protocols promptly with engaging work instructions that guide them through each step. Enjoy peace of mind knowing that the software complies with 21 CFR part 11 and EU Vol 4 annex 11. Simplify the logging of information with features like barcode scanning, integrated data integrity measures, and automatic calculations. The system also includes built-in mechanisms for identifying out-of-spec conditions and ensuring thorough review and approval. Stay informed about the status of your samples throughout the testing phases, while efficiently organizing sample plans and automating trend analysis. Additionally, manage tasks related to maintaining cleanroom standards and monitor various stages of the production process to ensure optimal results. This comprehensive approach not only enhances efficiency but also fosters an environment of accountability and precision in manufacturing.
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
Yes
Live Training (Online)
No
In Person
Yes
Vendor Details
Company Name
Caliber Technologies
Founded
2001
Country
India
Website
caliberuniversal.com/solutions/batch-record-management/
Vendor Details
Company Name
MyCellHub
Founded
2019
Country
Belgium
Website
www.mycellhub.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