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
Digital Logbook: Streamlining Room Logs for GMP Compliance. In the pharmaceutical industry, it is essential to document all activities in logbooks to adhere to Good Manufacturing Practice (GMP) standards. Traditional methods, such as handwritten logs or Excel spreadsheets, are often employed, but these can hinder the analysis of data and become prohibitively expensive due to labor-intensive maintenance and security issues. With our solution, you receive a user-friendly, adaptable, and scalable architecture that allows for the digitization of all room logs and forms, effectively capturing activities on the production floor. You can access your data conveniently and securely from anywhere at any time, enhancing both security and quality through the integration of personal digital signatures. Additionally, our system ensures compliance with GMP regulations by providing immutable records, with optional blockchain technology for added security. The process is simple: line operators can log activities or tasks with just a few clicks or taps, while multiple security layers safeguard the integrity of the logbook. Furthermore, customizable workflows align with your specific data entry and template approval processes, making it easier than ever to maintain compliance and efficiency. This modern approach not only simplifies record-keeping but also fosters a culture of accountability in pharmaceutical operations.
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
Yes
iPad App
Yes
Android App
Yes
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
Yes
Live Rep (24/7)
Yes
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)
Yes
In Person
Yes
Vendor Details
Company Name
Caliber Technologies
Founded
2001
Country
India
Website
caliberuniversal.com/solutions/batch-record-management/
Vendor Details
Company Name
Supply Chain Wizard
Founded
2014
Country
United States
Website
solutions.supplychainwizard.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
Logbook
Asset Tracking
No
Audit Trails
Yes
Data Search
Yes
Employee Time Clock
Yes
For Drivers
No
For Pilots
No
User Access Permissions
Yes
Violation Tracking
No
OEE
Benchmarking
Yes
Cost Tracking
Yes
Downtime Tracking
Yes
Historical Reporting
Yes
Performance Metrics
Yes
Quality Control
Yes
Real Time Reporting
Yes
Root Cause Analysis
Yes
Trend Analysis
Yes
Work Order Management
Yes
Production Scheduling
"What If" Scenarios
Yes
Automated Scheduling
Yes
Bottleneck Optimization
Yes
Capacity Planning
Yes
Constraint Scheduling
Yes
Job Scheduling
Yes
Material Planning
No
Priority-Based Scheduling
Yes
Quality Control
No
Time Clock
Biometric Recognition
No
Hourly Employee Tracking
No
Messaging
Yes
Mobile Access
Yes
Online Punch Card
No
Payroll Management
No
Punch card
No
Reporting/Analytics
Yes
Salaried Employee Tracking
No
Sick Leave Tracking
No
Vacation / Leave Tracking
No
Workstation Tracking
Yes