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
The Eyelit Technologies solution suite, Eyelit SIOP, Eyelit APS, Eyelit MES, and Agent EyeQ, are delivered on a single data platform. Eyelit Technologies provides a single platform and data model covering planning, regulatory record-keeping, and manufacturing management, in place of three separate systems.
Eyelit MES provides multi-level tracking and genealogy across serial, lot, batch, kit, and sub-assembly, traceable forward and backward in a single action. Eyelit MES maintains electronic controlled history records (eCHR) in which the customer defines exactly which elements are captured and nothing beyond them, with enforced control over operator skills, tools, documents, work instructions, and material consumption recorded against the history record. Eyelit MES supports Electronic Device History Records (eDHR) for medical device manufacturers under 21 CFR Part 11 and 21 CFR Part 820: electronic records, e-signature requirements, validation documentation, and audit trails.
Eyelit MES includes a pre-integrated real-time Statistical Process Control engine that detects process excursions before they affect yield. Eyelit MES and Eyelit APS run a continuous feedback loop: real-time WIP, downtime, and shop-floor changes pass from MES to APS, and updated schedules return to MES.
API Access
Has API
No
API Access
Has API
No
Screenshots View All
No images available
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Pricing Details
No price information available.
Free Trial
Yes
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
Yes
iPhone App
No
iPad App
No
Android App
No
Windows
Yes
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)
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)
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
Eyelit Technologies
Founded
1997
Country
United States
Website
eyelit.com/manufacturing-execution-system/
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
Yes
Forecasting
No
Quality Control
Yes
Quote Management
No
Resource Management
Yes
Supplier Management
Yes
Supply Chain Management
Yes
Traceability
Yes