Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Supplies and Components Index
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • MedTech Resources
    • Medtech Events in 2025
    • The 2024 Medtech Big 100
    • Medical Device Handbook
    • MedTech 100 Index
    • Subscribe to Print Magazine
    • DeviceTalks
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Podcasts
    • Print Subscription
    • Webinars / Digital Events
    • Whitepapers
    • Voices
    • Video
  • 2025 Leadership
    • 2024 Winners
    • 2023 Winners
    • 2022 Winners
    • 2021 Winners
  • Women in Medtech
  • Advertise
  • Subscribe

How cloud QMS simplifies software validation

February 25, 2019 By Nancy Crotti

Many manufacturers do not consider the cost and impact of software validation, but failing to do so can mean the difference between product introduction success or failure. 

Scott Reedy, Arena Solutions

(Photo by Markus Spiske on Unsplash)

FDA requires validation to demonstrate that quality management system (QMS) software meets its intended use.

Here’s how a medical device company can streamline its validation processes and focus on activities that generate revenue and win business.

Why validate?

Medtech manufacturers may use a paper-based quality system, on-premises software, or cloud-based software. FDA doesn’t specify the type of QMS system medtech manufacturers must use, just that they have a quality system that ensures products consistently meet applicable requirements and specifications.

However, the agency does require manufacturers to prove, or validate, that their software-based quality system meets the requirements for its intended use. Depending on the type of QMS software, the validation process can increase burdens on teams, draining resources and adding costs. Cloud-based QMS software is designed to be validated easily, even with regular enhancements, and can deliver high-quality, compliant products to market.

Reduce the burden

Medtech companies that purchase a cutting-edge QMS software solution expect to take advantage of capabilities that improve quality and increase transparency and historical tracking of information as they develop and release new devices. However, they too often forget to analyze the options for getting software enhancements or upgrades by failing to evaluate the initial impact and ongoing cost of validating the software.

FDA mandates validation for the initial implementation of the software as well as for upgrades. Upgrading on-premises software systems can be tricky, leading some device manufacturers to rely on outdated paradigms to base future validation decisions. Quality teams may hesitate to upgrade their QMS software because of the associated burdens of validation.

Traditional validation of on-premises solutions for each new software enhancement can lead to more than a drain on resources. For some companies, the time, expense, and effort associated with validating new versions outweighs the desire to take advantage of new functionality, even when that functionality will streamline quality and product-release processes. As a result, too many companies continue to rely on an outdated QMS software system that fails to keep up with technological advances, making it harder for the manufacturer to stay ahead of the competition.

Keep it simple

As cloud-based applications become more sophisticated, secure, and affordable, quality leaders should evaluate the advantages of using a multi-tenant cloud solution that adheres to current best practices in software validation, security, and innovation. Cloud-based QMS software with multi-tenant architecture provides a way to take advantage of ongoing advancements in technology while providing the lowest total cost of ownership (TCO) with a simplified validation experience. With a multi-tenant cloud solution, medtech companies can leverage software enhancements regularly without the traditional validation “heavy lifting” required by older on-premises or single-tenant QMS solutions.

Multi-tenant QMS solutions provide a level of shared infrastructure. The validation process is made easier by leveraging common test protocols for both installation qualification (IQ) and operational qualification (OQ) requirements. Paired with software provider’s validation maintenance service and validation experts, medical device manufacturers benefit from a better validation experience that reduces manual effort and time-consuming work. Removing traditional validation barriers enables companies to keep pace with the latest technological and functional features and frees quality and regulatory resources to focus on innovation, market responsiveness, and continual improvement to deliver high-quality products.

LNS Research found that software validation is one of the top challenges to speeding product development from early research and development to commercialization. When quality leaders don’t have to worry about validating software, they can focus on core competencies and, ultimately, accelerate the delivery of innovative and safe devices to market.

Scott Reedy is senior director of marketing for Arena Solutions. (www.arenasolutions.com). He spent a decade working in engineering and manufacturing and has held strategic roles with enterprise software companies in consulting, sales, product development and introduction, and marketing over the past 20 years.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of Medical Design and Outsourcing or its employees.

Related Articles Read More >

This is the logo of Siemens Healthineers.
Siemens Healthineers relocates Varian manufacturing from Mexico to U.S.
This is the logo of the U.S. Food and Drug Administration or FDA.
The FDA is turning to generative AI to boost efficiency
This a rendering of the new facility that Nelipak is planning in the Costa Rica Green Valley.
Nelipak healthcare packaging to expand operations in Costa Rica
This image shows a combination of the flags of the United States and the United Kingdom as AdvaMed and the Association of British HealthTech Industries call for zero medtech tariffs between the two countries.
AdvaMed is lobbying for a US-British medtech partnership
“mdo
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest medical device business news, application and technology trends.

DeviceTalks Weekly

See More >

MDO Digital Edition

Digital Edition

Subscribe to Medical Design & Outsourcing. Bookmark, share and interact with the leading medical design engineering magazine today.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
DeviceTalks

DeviceTalks is a conversation among medical technology leaders. It's events, podcasts, webinars and one-on-one exchanges of ideas & insights.

DeviceTalks

New MedTech Resource

Medical Tubing

MassDevice

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website
MDO ad
Medical Design and Outsourcing
  • MassDevice
  • DeviceTalks
  • MedTech100 Index
  • Medical Tubing + Extrusion
  • Medical Design Sourcing
  • Drug Delivery Business News
  • Drug Discovery & Development
  • Pharmaceutical Processing World
  • R&D World
  • About Us/Contact
  • Advertise With Us
  • Subscribe to Print Magazine
  • Subscribe to our E-Newsletter
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2025 WTWH Media, LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media LLC. Site Map | Privacy Policy | RSS

Search Medical Design & Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Supplies and Components Index
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • MedTech Resources
    • Medtech Events in 2025
    • The 2024 Medtech Big 100
    • Medical Device Handbook
    • MedTech 100 Index
    • Subscribe to Print Magazine
    • DeviceTalks
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Podcasts
    • Print Subscription
    • Webinars / Digital Events
    • Whitepapers
    • Voices
    • Video
  • 2025 Leadership
    • 2024 Winners
    • 2023 Winners
    • 2022 Winners
    • 2021 Winners
  • Women in Medtech
  • Advertise
  • Subscribe