The Infinity BiologiX team managed multiple transitions in 2020 combined with the currents of change brought by COVID-19. They chose to partner with ZenQMS to pivot their eQMS in 23 days to operationalize quality across teams, including a new COVID-19 testing site.
Key factors for Infinity BiologiX as they looked to switch eQMS platforms:
- Spinning out from Rutgers University into a private company
- Not satisfied with their current eQMS and had an approaching contract deadline
- High volume of COVID-19 testing led them to the rapid expansion of a COVID-19 satellite site
Mission accomplished: a 23-day implementation
When Infinity BiologiX decided to partner with ZenQMS, their request was: can we pivot from our legacy system and have ZenQMS up and running to support our satellite site in 30 days?
The ZenQMS team was ready for the challenge, and in partnership with the Infinity BiologiX quality team, they went live in 23 days.
Diana Baur, Senior Manager of Quality Assurance, who led the implementation and rollout, highlighted the importance of working with her ZenQMS Project Manager, Cason Walker, "The implementation was made very smooth by Cason…she calmly and kindly responded to everything I asked.”
Diana also found the variety of support material valuable from intuitive templates to walk-through videos: "The plan and support for implementation were there to provide me all the information I needed to do each stage of the process."
Swift adoption and immediate training management results
Even with quick implementation, adoption of the system by the broader team is vital. A system can only be effective if the team will use it.
Diana and her team saw swift adoption, for which she credits ZenQMS' easy-to-use design: "The intuitiveness of ZenQMS helped make that a less stressful transition."
Once Infinity BiologiX rolled out the system, the Quality team saw immediate results, specifically around training management:
"The ZenQMS user interface being so streamlined and intuitive helped us because we have noticed a steep increase in the ability of supervisors and managers to understand how to view the 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 the hands-on training management with each supervisor and direct report because the information is so accessible."
While the functionality was available in their previous eQMS, the lack of visibility and extra steps prevented the training data from being used. 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."
Factoring in key operations for distributed quality management, including supporting a new COVID-19 testing site
As part of their teams' efforts to support COVID-19 remediation, the volume of testing they performed made it necessary to open a satellite site quickly.
The Infinity BiologiX quality team had a few critical operational considerations:
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 to conduct virtual audits
Quickly scaling up onboarding and ensuring compliance
As Infinity BiologiX built their satellite site, they also needed to expand the team. For the Quality team, this meant scaling up onboarding, especially for contract team members.
To meet demand at the height of COVID testing, the Quality team was onboarding 8-12 new people a day and expanded their quality assurance team to support the expansion.
They used ZenQMS's automated training matrix via courses to manage the onboarding process in a systematic and replicable way:
"The onboarding is beautiful. It's perfectly streamlined and works very well. We have all our trainings in training courses set up for each employee type including contract. Contract training has been especially important because there is such a high throughput right now.”
The ease of use and visibility had a high impact from the compliance side, especially given the rapid expansion. As the team was using ZenQMS to onboard new hires, supervisors confirmed competence and compliance across the site with the dashboard:
"The ability of a supervisor to see their team's training records easily helped this 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."
Designing role and site-specific document access
Diana and her team knew the capability to add site-specific SOPs was significant. To provide the right amount of access and focus on use, 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, we needed to think through as a quality team how to divide access to the various document categories for employees from different sites. We managed that by assigning a unique group and giving that group access to a unique document category. Originally, we had a document category for all lab operations and sample processing. It was just one large category. They have way more documents come up for them to view than they need for their work, and it's just extraneous, so it makes it harder for them to find what they need."
Ensuring confidence in virtual audits
Virtual audits were a widely adopted practice during COVID-19, and for Infinity BiologiX, like many, the practice was new.
While still on their previous eQMS, Diana mentioned that there was an option to add an auditor into the system, but she wasn't 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 the auditors and initial set of documents that they've requested prior to the audit, then they can review them with us as we go through those days. If they request additional records during the process, 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.
About Infinity BiologiX
Infinity BiologiX (IBX) is a market-disrupting central laboratory supporting academia, government, and industry. IBX provides global sample collection, processing, storage, and analytical services integrated with scientific and technical support in both the research and clinical arenas. As a leader in biomaterials, IBX provides support to 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. For more information, visit ibx.bio.