Average Ratings 0 Ratings

Total
ease
features
design
support

No User Reviews. Be the first to provide a review:

Write a Review

Average Ratings 0 Ratings

Total
ease
features
design
support

No User Reviews. Be the first to provide a review:

Write a Review

Description

Arena's quality management system (QMS) software, designed specifically for product-centric environments, empowers medical device manufacturers to efficiently bring safe and compliant products to the market. By integrating quality and product processes, Arena QMS simplifies the new product development and introduction (NPDI) process. It provides assurance of regulatory compliance with essential quality standards and regulations, such as FDA 21 CFR Part 820, Part 11, and ISO 13485. Furthermore, Arena QMS improves visibility and traceability by managing quality processes in conjunction with various essential documentation, including bills of materials (BOMs), standard operating procedures (SOPs), device master records (DMRs), design history files (DHFs), specifications, drawings, and training plans. This holistic approach not only facilitates compliance but also fosters a culture of quality throughout the organization.

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.

API Access

Has API No 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

CaliberPulse No 
CalibereLog No 
Rimsys Yes 

Integrations

CaliberPulse Yes 
CalibereLog Yes 
Rimsys No 

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 No 
Android App No 
Windows No 
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 Yes 
Live Training (Online) Yes 
In Person Yes 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) Yes 
In Person Yes 

Vendor Details

Company Name

Arena, a PTC Business

Founded

2000

Country

United States

Website

www.arenasolutions.com/platform/qms/

Vendor Details

Company Name

Caliber Technologies

Founded

2001

Country

India

Website

caliberuniversal.com/solutions/batch-record-management/

Product Features

Quality Management

Audit Management Yes 
Complaint Management Yes 
Compliance Management Yes 
Corrective and Preventive Actions (CAPA) Yes 
Defect Tracking No 
Document Control Yes 
Equipment Management Yes 
ISO Standards Management Yes 
Maintenance Management No 
Risk Management Yes 
Supplier Quality Control Yes 
Training Management Yes 

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 

Alternatives

Total Lean Management (TLM) Software Reviews

Total Lean Management (TLM) Software

Lean & Mean Business Systems

Alternatives

Laurel MES Reviews

Laurel MES

Laurus Infosystems
Propel Reviews

Propel

Propel Software
QT9 ERP  Reviews

QT9 ERP

QT9 Software
Dot Compliance QMS Reviews

Dot Compliance QMS

QMS for Life Sciences
Mar-Kov Reviews

Mar-Kov

Mar-Kov Computer Systems