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Ratings and Reviews 0 Ratings
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What is CaliberBRM?
In the field of pharmaceutical manufacturing, it is essential to accurately capture activities on the production floor in real time to uphold quality standards and adhere to regulations such as 21 CFR Part 11 and Good Manufacturing Practices (GMPs). The use of an automated system ensures that batch records are devoid of errors and can be readily accessed, facilitating the monitoring of batch manufacturing procedures. Electronic Batch Record (EBR) systems, like CaliberBRM, supplant conventional paper documentation, thereby reducing risks and safeguarding data integrity and product quality. In highly regulated sectors, particularly within life sciences, the necessity of recording the 4Ms in real time becomes evident as it enhances business processes. The shift to digital batch production records can greatly diminish both time and effort. The EBR system offers thorough oversight of the 4Ms, which helps organizations to cut down on inventory waste, improve workforce management, efficiently handle instruments, and accelerate review cycles, ultimately resulting in lower operational costs. Additionally, Quality Review Management (QRM) highlights the significance of exception-based reviews, which not only expedite batch releases but also boost overall productivity. By adopting these innovative solutions, businesses can cultivate a more flexible and responsive manufacturing landscape, fostering continuous improvement and adaptability in their operations.
What is Arena QMS?
Arena's quality management system (QMS) software is designed to help medical device manufacturers efficiently launch safe and compliant products in the marketplace. By integrating quality and product workflows, Arena QMS facilitates a smoother new product development and introduction (NPDI) process. It guarantees adherence to various quality standards and regulatory requirements, such as FDA 21 CFR Part 820, Part 11, and ISO 13485. Furthermore, Arena QMS enhances visibility and traceability by overseeing quality processes in relation to bills of materials (BOMs), device master records (DMRs), standard operating procedures (SOPs), along with specifications, drawings, and training documentation. This holistic approach not only supports regulatory compliance but also fosters a culture of quality throughout the organization.
API Availability
API Availability
Pricing Information
Pricing not provided
Pricing Information
Pricing not provided
Supported Platforms
SaaS
Supported Platforms
SaaS
Customer Service / Support
Standard Support
Web-Based Support
Customer Service / Support
Standard Support
Web-Based Support
Training Options
Documentation Hub
Online Training
On-Site Training
Training Options
Documentation Hub
Webinars
Online Training
On-Site Training
Company Facts
Organization Name
Caliber Technologies
Date Founded
2001
Company Location
India
Company Website
caliberuniversal.com/solutions/batch-record-management/
Company Facts
Organization Name
Arena, a PTC Business
Date Founded
2000
Company Location
United States
Company Website
www.arenasolutions.com/platform/qms/
Categories and Features
Electronic Batch Records (EBR)
Not specified
Manufacturing
Quality Management
Reporting/Analytics
Manufacturing Execution
Quality Control
Pharmaceutical Manufacturing
Not specified
Categories and Features
Bill of Materials (BOM)
Not specified
Electronic Batch Records (EBR)
Not specified
Quality Management
Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Document Control
Equipment Management
ISO Standards Management
Risk Management
Supplier Quality Control
Training Management