12.9.2022 Jonah Krakow

    With ZenQMS, AavantiBio Runs an eQMS that is Easy-to-Implement and Fit-For-Purpose

    About AavantiBio

    Headquartered in Cambridge, MA, AavantiBio is on the forefront of innovative genetic medicine technologies and commercialization, developing a sustainable platform approach for Friedreich’s ataxia and expanding to other therapeutic modalities in diseases with significant unmet need.

    Business Need

    When Chief Technology Officer Paul Herzich and Director of Quality Faith Barnard joined AavantiBio, the company was in the process of evaluating electronic quality management systems (eQMS), but had not yet reached a decision. They had received quotes from large software companies with systems geared towards manufacturing sites, but nothing tailored to meet their needs as a smaller biotech company. These software systems also demanded lengthy implementations and financial resources that AavantiBio simply couldn’t justify. 

    “When I looked at implementation costs and implementation efforts, everything that was in the original evaluation by our consulting company was just ridiculous,” said Paul. 

    Faith had her own concerns about the systems’ appropriateness for AavantiBio, given her previous experience working with inflexible eQMS solutions. “Making software fit-for-purpose for your own organization is really important, especially in Quality systems. I worked with one where you couldn’t make any changes at all without hiring a consultant, and you had to wait a year for that consultant. You ended up building your system around the software instead of building the software around your system.”

    Years ago, a smaller biotech company like AavantiBio would be in a difficult position; wanting to move beyond manual and paper-based Quality systems, but at the mercy of large eQMS software companies and their exorbitant costs. They would have had to pay for unnecessary bells and whistles that didn’t apply to their model, all while sacrificing time and effort to complete a long and complicated implementation. 

    Fortunately for AavantiBio and other Life Sciences organizations looking to upgrade their quality management systems, times have changed. 

    Business Impact

    Paul had experience with ZenQMS from a previous employer and mentioned it to their consultants. “I view ZenQMS as an easy-to-use, cost-effective software platform for Phase 1 and Phase 2. And, even though I haven’t used it yet, I think it would work for Phase 3. So when I introduced it to our consultants, they were like, ‘Whoa, this is interesting. This is much better!’ It’s more affordable and three-to-four months faster from an implementation perspective.”

    By choosing ZenQMS, the entire AavantiBio team has access to an eQMS that is flexible and easy to roll out, especially from a compliance and validation standpoint. 

    “The biggest advantage I’ve seen is the time-frame from launch,” said Jackie Amador, an independent consultant at Amador Clinical Research Consulting who was in charge of implementation. “For example, a competitor I’ve used takes a lot longer to get everything built the way you want before you can actually start implementation and use it. ZenQMS is the fastest system to put into place, and that’s its greatest benefit.” 

    “The biggest ROI of ZenQMS is being compliant from the get-go,” added Faith. “I’ve been at many companies where they’ve implemented a document control system, which is a huge project to get up and running, but they still did deviations and training on paper. It makes a lot more sense to implement something like ZenQMS, where all the modules are available and included, and we can roll them out as we need to.” 

    Moving away from manual and paper systems doesn’t have to be painful. If you’re looking for an eQMS that’s right-sized and purpose-built for your organization, schedule a demo with ZenQMS. 

    Published by Jonah Krakow December 9, 2022
    Jonah Krakow