How Sampled used ZenQMS to operationalize quality in 23 days
*NOTE: In April, 2022, Infinity BiologiX announced a rebrand with Roylance Pharma to create Sampled. This Infinity BiologiX case study was written prior to the rebrand.
Infinity BiologiX (IBX) is a leading biomaterials laboratory supporting the development of diagnostics, therapeutics, and research in the genomics, precision, and regenerative medicine arenas. IBX previously operated as RUCDR Infinite Biologics before spinning out from Rutgers University-New Brunswick in August 2020.
The year 2020 was unprecedented for businesses around the world, and like many, IBX found itself in transition:
- - High demand for tests led to a rapid expansion into a new satellite COVID-19 testing site.
- - Spinning out from Rutgers University to form a private company led to its own set of complications including systems/operational separation
- - A key transitional point was acquiring/establishing a separate quality management system ahead of the planned expiration of the existing contract.
They came to ZenQMS with a challenging request:
“Can we pivot from our legacy system to ZenQMS and have it operating across all of our teams, including the new COVID-19 testing site, in 30 days?”
Not shy about tackling such a challenge, ZenQMS worked hand in hand with the IBX quality team to beat the deadline.
Mission Accomplished: A 23-day implementation.
Diana Baur, Senior Manager of Quality Assurance, who led the implementation and rollout, highlighted the importance of working with her assigned ZenQMS project manager (PM).
"The implementation was very smooth. My PM calmly and kindly responded to everything I asked.” She also found the variety of support materials valuable, from intuitive templates to walk-through videos: "Implementation plans and support were there to provide me with all the information I needed to complete each stage of the process."
Diana’s team saw a swift adoption of ZenQMS, for which she credits the solution’s easy-to-use design: "The intuitiveness of ZenQMS helped make it a less stressful transition." Once IBX rolled out the system, the Quality team saw immediate results, specifically around training management:
"With the ZenQMS user interface being so streamlined and intuitive, it’s helped us because we’ve now noticed a steep increase in our supervisors’ and managers’ ability to understand how to view training records and enforce them. Having a visual dashboard to see your direct reports makes it very easy, and I have definitely seen an increase in hands-on training management with each supervisor and direct reports because the information is so accessible."
While their previous eQMS included some compliance training data, it was difficult to access and use. Diana noted that finding a system that allows supervisors and managers to quickly access and action data was key: "That's always at the top of my list for the QA team's time."
As part of IBX's efforts to support COVID-19 remediation, the volume of testing they performed made it necessary to open a new satellite testing site quickly. However, the nature of the virus forced their Quality team to consider:
Scaling the onboarding process for a high volume of new contract team members while ensuring training compliance
Rethinking the organization of standard operating procedures (SOPs) and quality procedures to include site-specific requirements
Pivoting from in-person to virtual audits
Onboarding Employees and Assigning Dynamic Training on the Fly
To meet demand at the height of COVID testing, the Quality team was onboarding 8-12 new employees a day and expanding their quality assurance team to support the expansion. They used ZenQMS's automated training matrix to manage the onboarding process in a systematic and replicable way.
"The onboarding is beautiful,” said Diana. “It's perfectly streamlined and works very well. Contract training has been especially important because there is such a high throughput right now.”
Ease-of-use and visibility had a high impact from the compliance side, especially given IBX’s rapid expansion. The decision to use ZenQMS for onboarding gave supervisors confirmation that new hires were competent and compliant across the site.
"The ability of supervisors to see their team's training records easily helped the process because, when we brought on supervisors for the new site, they were able to see the site's training status before they even met everyone. We were able to ensure that the site was compliant quickly."
Role and Site-specific Document Access Means Effortless Control
Diana and her team knew that ZenQMS’ capability to add site-specific SOPs was significant. In order to provide the appropriate permissions for each user, they strategized how to organize document access to meet their team members' needs best, especially considering the new satellite location. They used the different categories and filters in ZenQMS's Documents module to design a system that served exactly what was needed by role and location.
"We opened a satellite site just for processing COVID testing. As a result, our Quality team needed to think through how to assign access to various document categories for employees from different sites. We managed that by creating a unique group and giving that group access to a unique document category."
Virtual Audits - A Critical Necessity for all GxP Companies Today
Virtual audits were a widely-adopted practice during the COVID-19 lockdown period, but for many highly-regulated companies like IBX, the practice was new. Their previous eQMS had an option to add an auditor into the system, but Diana was never confident that the permissions were correct.
“I was never completely convinced that I was setting it up correctly, that they could only see what they needed to see, and I didn't have that level of certainty. But with ZenQMS, we've been able to do it very readily."
Now, Diana and her team can effectively and efficiently execute their audits virtually, even more so than in person.
"It's been very easy to provide auditors with the initial set of documents they've requested prior to the audit. Then, they can review them with us as we go through the process. If they request additional records, we're able to scan and add them in real-time as we are conversing."
Especially during times of immense change, Quality teams are called on to be strategic safeguards; advancing the process and maintaining safety. ZenQMS is proud to support Infinity BiologiX in their efforts in mitigating COVID-19 and throughout their quality journey.