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What is Quality Planning Studio?

Quality Planning Studio's FMEA software expertly integrates critical quality tools, ensuring adherence to vital stages in process flow. This comprehensive software solution streamlines planning, documentation, and management of essential quality standards. For manufacturers worldwide, FMEA serves as a fundamental component of continuous improvement strategies. The synergy between Process Flows, FMEA, control plans, and SPC is crucial for advancing quality initiatives. The FMEA methodology fosters a relentless pursuit of enhancement for products, processes, and detection techniques. Engineers involved in FMEA benefit from real-time insights gained from SPC results observed on the production floor. The QPS database effectively consolidates all necessary information, preserving the traceability and integrity of Process Flow, FMEA, and Control Plan data across multiple manufacturing sites. Moreover, QPS is designed to work seamlessly with our SPC software, DataMetrics, which optimizes operations by reducing redundancy and allowing for effective tracking of characteristic capabilities outlined in the Control Plan. This integration not only boosts overall operational efficiency but also fortifies quality assurance measures, ultimately leading to superior product outcomes. By leveraging this advanced software, manufacturers can ensure their processes are both efficient and compliant with industry standards.

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.

Media

Media

Integrations Supported

Rimsys

Integrations Supported

Rimsys

API Availability

Has API

API Availability

Has API

Pricing Information

$2000.00/one-time/user
Free Trial Offered?
Free Version

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

DATAMYTE

Date Founded

1967

Company Location

United States

Company Website

www.datamyte.com/qps

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

Quality Management

Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management

Categories and Features

Quality Management

Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management

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