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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

OpsTrakker is the digital platform to kickstart your digital transformation. OpsTrakker replaces manual forms, use-logs and spreadsheets with mobile apps that leverage real-time electronic information to improve manufacturing operations. The current digital solutions include equipment logbooks (logbooks), forms and checklists as well as equipment tracking tools for the pharmaceutical, biotech, and life sciences industries. OpsTrakker bridges between paper-based and full-feature MES solutions. It can eliminate all paper from your shop floor. OpsTrakker's mobile apps are designed to address specific needs and provide cost-effective manufacturing operations management functionality. OpsTrakker allows you to quickly deploy on any device or system. You can create site-specific features and have a user-friendly interface to make it easy to meet your production needs.

API Access

Has API No 

API Access

Has API Yes 

Screenshots View All

Screenshots View All

Integrations

CaliberPulse Yes 
CalibereLog Yes 
SAP Store No 

Integrations

CaliberPulse No 
CalibereLog No 
SAP Store Yes 

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 Yes 
Android App Yes 
Windows Yes 
Mac Yes 
Linux No 
Chromebook Yes 

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

Enhanced Information Solutions

Founded

1994

Country

United States

Website

opstrakker.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

Forms Automation

Approval Process Control Yes 
Archiving & Retention No 
Collaboration No 
Document Indexing Yes 
Drag & Drop Yes 
Full Text Search No 
Remote Document Access Yes 
Rules-Based Workflow Yes 
Text Editing Yes 
Version Control Yes 

Industrial IoT

Condition Monitoring Yes 
Data Visualization Yes 
Factory Data Analytics Yes 
Machine Learning No 
Machine Workflow Creation Yes 
Predictive Maintenance No 
Production Line / Factory Insights Yes 
Real-Time Monitoring Yes 
Reporting / Analytics Yes 
Smart Alerts / Notifications Yes 

Logbook

Asset Tracking Yes 
Audit Trails Yes 
Data Search Yes 
Employee Time Clock No 
For Drivers No 
For Pilots No 
User Access Permissions Yes 
Violation Tracking No 

Manufacturing

Accounting Integration No 
ERP Yes 
MES Yes 
MRP No 
Maintenance Management Yes 
Purchase Order Management No 
Quality Management Yes 
Quotes/Estimates No 
Reporting/Analytics Yes 
Safety Management No 
Shipping Management No 

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