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What is PRO.FILE?

Revalize's PRO.FILE is a comprehensive digital platform that effectively manages documents and data related to products while also streamlining associated processes through automation. This solution is tailored to accommodate five specific use cases, all of which are seamlessly integrated, enabling users to begin with a small implementation and scale as necessary. It facilitates the bi-directional transfer of Bill of Materials (BOM) from ERP systems, along with the sharing of part master data and related documents. In addition, it provides robust traceability and revision control features. Users can monitor critical business metrics such as time to market, average duration of changes, and conduct impact analyses through advanced reporting capabilities. The system also supports automated task assignments, allowing for the efficient creation and management of custom workflows, whether for Engineering Change Orders (ECO), New Product Introductions (NPI), or other business processes. Moreover, the organized connection of product data to related documents guarantees both traceability and audit compliance within the organization, thus enhancing overall operational efficiency.

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

Revalize
Rimsys

Integrations Supported

Revalize
Rimsys

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided.
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

Revalize

Date Founded

1985

Company Location

Germany

Company Website

www.pro-file.com/en/

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

Product Lifecycle Management

Change Management
Compliance Management
Cost Tracking
Design Management
Document Management
Product Data Management
Project Management
Requirements Management
Supplier 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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