Nuvolo Briefing Note
Axendia was recently briefed by Ethan Smith, General Manager, Life Sciences at Nuvolo, a cloud-based software company founded in 2014 and built on the ServiceNow platform. Nuvolo’s vision is to deliver on the promise of a fully connected workplace. Its 200+ clients are connecting people, locations, physical assets and business services on the same platform. “We are the only end-to-end Integrated Workplace Management System (IWMS) that has been built and designed for Life Sciences,” said Smith.
Nuvolo Connected Workplace for Life Sciences
“Users need to be able to seamlessly go between our facilities application and our asset management application,” explained Smith. Fulfiller licenses to Connected Workplace for Life Sciences provide users access to all of these apps within the suite. That model is unique to Life Sciences because the nature of the business requires users that maintain assets, facilities and spaces whereas other industries have a more segmented user community. Manufacturing users may be reserving space in a clean room and assets to do a manufacturing production run. They need to be able to do all of functions in one place, so we bundle Connected Workspace for Life Sciences to include everything users need to accomplish their work.”
For Nuvolo Life Science customers, a full audit and compliance layer sits underneath the application suite. 21 CFR Part 11 and GxP requirements are seamlessly applied to any of the components within the suite. Additionally, since Connected Workplace is built on ServiceNow, it is what’s referred to as a scoped application, meaning it natively sits on the platform itself. Nuvolo also offers IWMS as a mobile solution which includes offline mobile access.
Compliance with a Click
Nuvolo’s GxP Asset Management (GAM) application supports non-GxP and GxP assets, as well as the classification of those assets from one state to the other. “We refer to it as ‘compliance with a click’. When GxP applicability is set for an asset, we automate the electronic change request processes and all of the necessary controls to make sure that asset follows the right quality processes and approvals,” explained Smith.
Asset onboarding data – from procurement processes through qualification and use – are captured in the platform. “Historically, calibration has been a separate set of tools. However, we do that all within our asset management application. The reasoning behind that is we fundamentally believe you’re not managing the asset if you’re not also including its calibration,” elaborated Smith. Nuvolo supports both external calibration / metrology service providers, as well as users executing the calibration steps / test points within the solution. “We can capture every test point, step-by-step, record it and generate the certificate of calibration. We can also accept a calibration certificate from an external vendor to avoid adding cost and burden to a client that’s already doing this outside of the solution,” continued Smith.
Lastly, any application that a customer is using on the ServiceNow platform, has built in connectivity to Nuvolo since the solution is running on that same instance. “Almost all of our customers use what ServiceNow calls a qualified instance. ServiceNow provides an IOQ – essentially the IQ of the infrastructure – that is provided to the client. We [Nuvolo] have an extension of the IQ, and then we have our own OQ that’s built on top of that, that we take through the pre-validation of our base software with each one of our releases,” clarified Smith.
Nuvolo SMB is a multi-tenant environment, fully configured based on best practices available for smaller, emerging Biotech companies. “We are able to validate this offering all the way through PQ because we maintain the configuration of it. And, because it’s a managed solution, this offering has a lower price point which results in faster time-to-value,” explained Smith.
Although many still exist today, point solutions are obsolete. Built on the ServiceNow platform, Nuvolo Connected Workplace for Life Sciences brings facilities, space and asset management data together in one solution. Digital Alignment of Manufacturing and Quality (DAMQ) is set to be released in September 2022 and we will provide an update once available.
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The opinions and analysis expressed in this Briefing Note reflect the judgment of Axendia at the time of publication and are subject to change without notice. Information contained in this document is current as of publication date. Information cited is not warranted by Axendia but has been obtained through a valid research methodology. This document is not intended to endorse any company or product and should not be attributed as such.