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Average Ratings 0 Ratings

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ease
features
design
support

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Write a Review

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

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

CaliberPulse
CalibereLog

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

Supply Chain Wizard

Founded

2014

Country

United States

Website

solutions.supplychainwizard.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

Logbook

Asset Tracking
Audit Trails
Data Search
Employee Time Clock
For Drivers
For Pilots
User Access Permissions
Violation Tracking

OEE

Benchmarking
Cost Tracking
Downtime Tracking
Historical Reporting
Performance Metrics
Quality Control
Real Time Reporting
Root Cause Analysis
Trend Analysis
Work Order Management

Production Scheduling

"What If" Scenarios
Automated Scheduling
Bottleneck Optimization
Capacity Planning
Constraint Scheduling
Job Scheduling
Material Planning
Priority-Based Scheduling
Quality Control

Time Clock

Biometric Recognition
Hourly Employee Tracking
Messaging
Mobile Access
Online Punch Card
Payroll Management
Punch card
Reporting/Analytics
Salaried Employee Tracking
Sick Leave Tracking
Vacation / Leave Tracking
Workstation Tracking

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