Koneksa saves a week per month and uses it for continuous improvement

Who are Koneksa?
New York, N.Y.
Company size
51-200 employees

Koneksa provides digital biomarker technology to clinical trial sponsors to unlock the remote capture of clinical data from patients.

With wearable actigraphic technology and a connected SaaS platform, Koneksa's customers are empowered with real-time data from their clinical trial patients - from vital signs and spirometry to gait and balance.

Koneksa works to the quality and compliance requirements of Good Clinical Practice (GCP) and ICH E6, as well as the information security benchmarks of ISO 27001 and the GDPR.

The challenge

In 2020, Koneksa was beginning to realize its ambitious growth plans - but a legacy quality management system was holding it back.

A combination of multiple learning management systems (LMS), Google folders, spreadsheets and manual document and training management activities was just possible in Koneksa's infancy - but simply couldn't keep up as the company pursued its growth objectives.

As we started to grow, the way we were managing our training was going to become untenable.

— Stan Spagnuolo, Director of Quality Assurance, Koneksa
The solution

Koneksa evaluated 5 different eQMS vendors.

They chose Qualio for its out-of-the-box readiness, implementation simplicity, and the desire to partner with a vendor on a similar growth trajectory.

Qualio was rolled out across the quality team in late 2020, and across the entire business in mid-2021.


Qualio was starting to introduce something different to what the other vendors were offering.

Most of these other eQMS systems require you to speak the system's language to do what you want to do, or fit what you want to fit into it.

— Stan Spagnuolo, Director of Quality Assurance, Koneksa
The results

Qualio made an immediate impact on the Koneksa team's approach to quality and compliance, turning quality management from an admin-heavy tickbox exercise to a natural and supported component of the company culture.

1. 25% reduction in training management time


Director of Quality Assurance Stan Spagnuolo estimates a time saving of a whole week every single month, thanks to the replacement of manual training processes with Qualio's digitized and automated training functionality.

Folks that have been here for a while and have gone through all of the old ways of training are saying, "this is fantastic!"

— Stan Spagnuolo, Director of Quality Assurance, Koneksa

2. Repurposed time

What quality problems could you solve with an extra week each month?

Stan and his team decided to capitalize on the time savings delivered by Qualio to strengthen and refine their approach to quality events like CAPAs, NCRs and audit findings.

By applying Qualio's Events functionality, including tags, Koneksa have unlocked granular control and visibility of their quality landscape across what was previously a complex raft of client and clinical study data.


3. Business-wide engagement

The Koneksa quality team noticed an immediate uptick in engagement with quality activities like training, thanks to the user-friendliness of Qualio.

This, in turn, allowed more training to be completed - strengthening the Koneksa workforce and embedding demonstrable competence and compliance.

By making the process easier and simplifying it in Qualio, we actually did see things getting done, rather than having to 'wrangle the cats'.

People are doing their training now. And I think that the reason for that is just that it's simple to do. And it's more of an enjoyable situation than it was in the past. 

— Stan Spagnuolo, Director of Quality Assurance, Koneksa

4. Deeper metrics and faster reporting

A robust QMS is impossible without rapid and easy access to trusted, up-to-date data.

The Koneksa team replaced time-heavy spreadsheet interrogation with touch-of-a-button reporting from within the Qualio system.

Information like training activity, quality event data and document statuses can now be quickly compiled on the day of  management meetings, rather than days before.

In turn, Koneksa management enjoy access to accurate and real-time quality metrics - and can make stronger, smarter decisions as a result.




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