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
Alongside the need for consistent product quality and process reproducibility, batch processes face additional hurdles: Market and consumer expectations for product variety are on the rise, product life cycles are shortening, regulatory standards are expanding, and traceability control requirements, such as those mandated by the FDA, are tightening. To address all these batch automation needs and market challenges, the SIMATIC PCS 7 process control system provides an effective solution. The SIMATIC BATCH software suite, equipped with recipe support, adeptly handles even the most intricate tasks with adaptable control processes. Serving as the heart of batch operations, the SIMATIC BATCH Batch Control Center (BatchCC) facilitates the management, oversight, and regulation of batch processes, ensuring that manufacturers can respond to evolving demands swiftly. Consequently, utilizing such advanced systems enables businesses to maintain competitiveness and compliance in a rapidly changing industry landscape.
API Access
Has API
API Access
Has API
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
Siemens
Country
Germany
Website
new.siemens.com/global/en/products/automation/process-control/simatic-pcs-7/batch-automation.html
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
Engineering
2D Drawing
3D Modeling
Chemical Engineering
Civil Engineering
Collaboration
Design Analysis
Design Export
Document Management
Electrical Engineering
Mechanical Engineering
Mechatronics
Presentation Tools
Structural Engineering