Case Studies Proscia Uses Qualio to Bring High-Quality Medical Device Software to Pathologists around the World

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	Proscia Uses Qualio to Bring High-Quality Medical Device Software to Pathologists around the World

Proscia Uses Qualio to Bring High-Quality Medical Device Software to Pathologists around the World

Technology Category	Functional Applications - Enterprise Resource Planning Systems (ERP) Functional Applications - Product Lifecycle Management Systems (PLM) Functional Applications - Remote Monitoring & Control Systems
Applicable Industries	Healthcare & Hospitals Software
Applicable Functions	Product Research & Development Quality Assurance
Use Cases	Regulatory Compliance Monitoring Remote Collaboration Remote Control
Services	Software Design & Engineering Services System Integration Training
Challenge	To sell their medical device software to healthcare customers, Proscia needed a quality management system that would enable them to enforce high quality standards to ensure compliance with all relevant regulations. Since they wanted to sell their product internationally, the company needed a solution that would help them achieve MDSAP certification thereby ensuring compliance with FDA and ISO regulations and allowing them to sell to organizations in Australia, Brazil, Canada, Japan, the European Union, and the United States. Read More
About Customer	Since 2014, Proscia has been building software solutions for pathology and cancer research. The company recently decided to apply their software to a clinical setting to enable pathologists to work more effectively by moving from microscope-based workflows to a slide image management system that imports and reads digitized slides from multiple scanning sources, making it easier for doctors to store, retrieve, manipulate, and annotate them from any location where there is internet access. To ensure the transition to the new market was a smooth one, Proscia needed a complete and compliant electronic quality management system (eQMS) that was cost-effective and could be implemented rapidly. After researching their options, they chose Qualio and were able to achieve Medical Device Single Audit Program (MDSAP) compliance shortly thereafter, allowing them to bring powerful software as a medical device to pathologists around the world. Read More
Solution	As they searched for a new solution, the team at Proscia demoed three products, including Qualio. Ultimately, they chose Qualio as their eQMS because of its simplicity and intuitive user interface. Proscia has many young designers on staff who aren’t used to working in regulated environments; Qualio has made these employees’ transition to this kind of work setting much easier. In particular, Proscia enjoys Qualio’s search function, which enables them to quickly find documents by keyword and reference IDs that appear either within the documents themselves or in document properties. They also enjoy Qualio’s tag function which enables multiple documents to be grouped into sets that are created as needed and allows documents to belong to more than one group. Read More Log in to view content
Contents

Technology Category

Functional Applications - Enterprise Resource Planning Systems (ERP)

Functional Applications - Product Lifecycle Management Systems (PLM)

Functional Applications - Remote Monitoring & Control Systems

Applicable Industries

Healthcare & Hospitals

Software

Applicable Functions

Product Research & Development

Quality Assurance

Use Cases

Regulatory Compliance Monitoring

Remote Collaboration

Remote Control

Services

Software Design & Engineering Services

System Integration

Training

Challenge

To sell their medical device software to healthcare customers, Proscia needed a quality management system that would enable them to enforce high quality standards to ensure compliance with all relevant regulations. Since they wanted to sell their product internationally, the company needed a solution that would help them achieve MDSAP certification thereby ensuring compliance with FDA and ISO regulations and allowing them to sell to organizations in Australia, Brazil, Canada, Japan, the European Union, and the United States.

About Customer

Since 2014, Proscia has been building software solutions for pathology and cancer research. The company recently decided to apply their software to a clinical setting to enable pathologists to work more effectively by moving from microscope-based workflows to a slide image management system that imports and reads digitized slides from multiple scanning sources, making it easier for doctors to store, retrieve, manipulate, and annotate them from any location where there is internet access. To ensure the transition to the new market was a smooth one, Proscia needed a complete and compliant electronic quality management system (eQMS) that was cost-effective and could be implemented rapidly. After researching their options, they chose Qualio and were able to achieve Medical Device Single Audit Program (MDSAP) compliance shortly thereafter, allowing them to bring powerful software as a medical device to pathologists around the world.

Solution

As they searched for a new solution, the team at Proscia demoed three products, including Qualio. Ultimately, they chose Qualio as their eQMS because of its simplicity and intuitive user interface. Proscia has many young designers on staff who aren’t used to working in regulated environments; Qualio has made these employees’ transition to this kind of work setting much easier. In particular, Proscia enjoys Qualio’s search function, which enables them to quickly find documents by keyword and reference IDs that appear either within the documents themselves or in document properties. They also enjoy Qualio’s tag function which enables multiple documents to be grouped into sets that are created as needed and allows documents to belong to more than one group.

Impact #1	More than 30 Proscia employees are using Qualio every day to help bring medical device software to the global healthcare market. With Qualio, the team has access to a trusted system that serves as a single source of truth for documentation.
Impact #2	Proscia used Qualio to prepare for and ultimately achieve MDSAP certification by ensuring that all necessary documentation was available, up-to-date, organized, and approved.
Impact #3	While Qualio’s intuitive design made adoption easy, organizations often run into issues when implementing any new software solution, including an eQMS. Thanks to Qualio’s top-tier customer support offerings, the Proscia team was able to quickly get past any problems they encountered.

Impact #1

More than 30 Proscia employees are using Qualio every day to help bring medical device software to the global healthcare market. With Qualio, the team has access to a trusted system that serves as a single source of truth for documentation.

Impact #2

Proscia used Qualio to prepare for and ultimately achieve MDSAP certification by ensuring that all necessary documentation was available, up-to-date, organized, and approved.

Impact #3

While Qualio’s intuitive design made adoption easy, organizations often run into issues when implementing any new software solution, including an eQMS. Thanks to Qualio’s top-tier customer support offerings, the Proscia team was able to quickly get past any problems they encountered.

Benefit #1	Proscia achieved MDSAP certification, allowing them to sell to organizations in Australia, Brazil, Canada, Japan, the European Union, and the United States.
Benefit #2	More than 30 Proscia employees are using Qualio every day.

Benefit #1

Proscia achieved MDSAP certification, allowing them to sell to organizations in Australia, Brazil, Canada, Japan, the European Union, and the United States.

Benefit #2

More than 30 Proscia employees are using Qualio every day.

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Overview

Proscia Uses Qualio to Bring High-Quality Medical Device Software to Pathologists around the World

Operational Impact

Quantitative Benefit