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Sophia Finn


Considering a Move to a Pure-Cloud QMS?

Five essential characteristics to look for

Published: Tuesday, July 25, 2017 - 11:02

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The quality sector hasn’t seen real software innovation for nearly two decades. Even with an overabundance of options, the available quality software is fragmented, and its dated technology leaves a lot to be desired.

Ineffective quality management systems (QMS) can lead to quality failures, which damage a company’s reputation, waste time, and lead to unanticipated costs. As a result, organizations are replacing paper-based processes and outdated legacy QMS software with modern, cloud solutions to improve productivity and reduce risks.

Many organizations are operating with a “cloud first” mandate. In fact, Gartner reports that more than $1 trillion in IT spending will be directly or indirectly affected by the shift to cloud by 2020.

However, many quality management solutions masquerading as “cloud” aren’t truly cloud. In fact, these solutions are the same old on-premise software systems, just hosted off premise. In other words, these systems are online versions of legacy software and therefore do not deliver all of the highly touted benefits of the cloud.

What’s the difference?

The defining attribute of a true cloud solution is multitenancy. Multitenancy enables the secure deployment of only one version of cloud software to all customers and quick, ongoing innovation that minimizes IT burden. In contrast, hosted online systems require vendors to maintain multiple versions of software, resulting in a substandard product with infrequent upgrades that are time-consuming for customers to implement.

For organizations considering a transition to a pure-cloud QMS, here are five characteristics of a modern, multitenant cloud solution that will meet today’s quality management needs and contribute to organizational objectives beyond quality.

1. Complete: Everything in a single system
Siloed legacy systems require users to toggle between several disconnected quality and document control modules. And limited integration prevents visibility across business processes. The cloud can seamlessly bring together multiple solutions such as QMS, document management, dashboards, and reports on a single unified suite for improved control, visibility, partner collaboration, and ultimately, better quality outcomes.

“We’ve been able to harmonize globally on a single system so that processes and document templates can be standardized,” says Cara Weyker, vice president of CMC regulatory and quality at Horizon Pharma, who implemented a Veeva Vault Quality cloud-based application. “This reduces the risk of making errors or duplicating efforts.”

2. Inclusive: Collaborate securely with external stakeholders.
A multitenant cloud application meets the most stringent requirements for secure collaboration. Organizations can bring external stakeholders into internal quality processes easily and securely to reduce manual efforts and improve collaboration. Because many hosted QMS cloud solutions are merely instances of legacy software hosted in the cloud, the same issues with secure collaboration persist. A multitenant cloud QMS solution gives any authorized user access from any device, at any time, from anywhere.

James Huang, director of global quality systems at Atrium Innovations, recognized the value of including all stakeholders into quality processes with a unified quality management system and document control solution in the cloud. “We’ve created a more integrated approach to bring all the parties globally together,” says Huang after implementing Veeva’s complete Vault Quality suite. “When we make changes, all parties will be involved, so we can collaboratively solve the problem. The technology will provide the opportunity to harmonize different business processes.”

3. Innovative: Keep pace as the business scales.
With on-premise QMS technology, the security cost, risk, and accountability is shouldered by each individual customer. With a multitenant cloud QMS solution, the burden is shouldered by a cloud company that is continually making ongoing investments to deliver multiple annual updates to keep up with new regulations and industry best practices. This reduces the burden on IT and allows them to focus on fine-tuning the quality application and aligning business areas.

Kevin Loftus, quality assurance manager at Medicines360, was impressed with the rapid implementation possible with a multitenant cloud application. “As a small company, we thought moving to a new system would be a year-long project,” says Loftus, who implemented a Veeva Vault Quality cloud-based application. “Instead, it was only four weeks to get the system up and running with our configuration, including workflows. It took only another four weeks to have 80 percent of our quality management documents fully migrated.”

4. Intuitive: Ease-of-use drives adoption, efficiency.
User experience is starkly different between multitenant cloud applications and legacy quality system software. Loftus observed significant efficiency gains with Veeva’s multitenant cloud application. “In terms of managing our document life cycle and taking documents from draft through review, revision, approval, issuance, and training, we have been more productive in the last six months than the entire year before,” says Loftus.

Simplifying the user experience not only increases efficiency, but also compels users to consistently work within the system. This was the case at Conatus Pharmaceuticals. “Simplicity not only makes us more productive and efficient, but also encourages users to leverage the full functionality of the system, which improves our return on investment,” explains Steve Mento, CEO of Conatus Pharmaceuticals, who’s company implemented a Veeva Vault Quality cloud-based application.

5. Visibility: Make decisions with real-time data.
With a unified quality management system in the cloud, users can easily view real-time status of activities with built-in dashboards and reports, and conduct ongoing analysis to identify areas for improvement. This capability shifts an organization from reactive to proactive and can positively impact business areas beyond quality.

Increased visibility was a significant contributor to Horizon’s strategic value. “We run reports on a wide range of document life-cycle metrics across the enterprise, and are now able to anticipate potential bottlenecks or compliance risk well in advance,” adds Weyker.

Ready for a true cloud QMS solution?

The transition to cloud will continue to gain significant momentum. With many cloud options available, it can be difficult to decide which path to take. But as many organizations are realizing, a true, multitenant cloud QMS solution can deliver significant benefits.

“I knew we had to move to the cloud to optimize our resources,” Loftus at Medicines360. “When we started our search, I wasn’t sure we could find a solution that would not require significant customization.” He soon learned that the cloud could give him the specialized functionality he needed in an interface that’s easy to use for end users and administrators. “It saves considerable time and resources.”


About The Author

Sophia Finn’s picture

Sophia Finn

Sophia Finn spent the early part of her career literally in the trenches, working for United States Air Force Reserve followed by seven years in various regulatory affairs roles at the U.S. Food and Drug Administration. In 2013, Finn experienced her first FDA inspection from the perspective of private industry and, through that eye-opening experience, learned the full business impact of noncompliance.

As director of Vault QualityOne strategy, and certified ASQ-certified quality auditor, Finn uses her extensive experience with 21CFR 820, 21 CFR 803, ISO13485, ISO17025, post-market surveillance, and CAPA, auditing, compliant process, and MDRs to help customers build robust quality processes into their systems early and share these widely across the entire enterprise.


Great Article

I have been designing QMS solutions with customers for nearly 20 years using a client/server application. Currently I am working as part of a team to provide a web alternative and your discussion about a cloud based solution is very intriguing. Providing a QMS solution that does not rely on a site managed or hosted installation is highly desirable.

Thank you for this article.