Positioning a biotech start-up for long-term success
Enara Bio is a UK-based biotech start-up pushing the boundaries of cancer immunotherapy.
The company is keen to position itself for simple, right-first-time success when quality and compliance demands begin to arrive.
A number of regulatory and compliance benchmarks, have to be considered and mastered early.
Prior to Qualio, Enara Bio operated a largely manual system to oversee documentation and training activity.
This system operated effectively while the company was very small.
But managing and tracking Word documents in SharePoint, and relying on spreadsheet-based training processes, meant a loss of time to administration and duplicated effort as headcount and internal activity grew.
We had lots of cells in the training spreadsheet with nothing in them.
People could've done their training and not ticked it - or they might not have done it at all. There was no way of telling.
I suspect people had to redo training. Then they had to be chased again to confirm if they'd done it.
It was a headache.
Above all, Head of Business & Portfolio Optimization Kate Nicholson was keen to take a proactive approach to quality and compliance - weaving best practice into day-to-day operations before they became mandated by external regulatory requirements.
The Enara Bio team is an expert group of experienced pharmaceutical and biotech industry professionals.
The team wanted to pursue an eQMS investment to optimize quality - while not recreating past experiences of large, clunky platforms with layers of superfluous functionality.
A simple, lean and uncluttered approach was required, and this need structured the eQMS search.
Kate led a detailed procurement process which saw multiple eQMS platforms evaluated.
As complicated pricing and confusing modular set-ups caused other platforms to be taken off the table, the team focused in on Qualio as their preferred system.
Enara Bio became Qualio customers in April 2022.
Qualio's functionality and clean, simple user experience aligned perfectly with the company's wish for uncomplicated quality processes, and the system has made an immediate impact on Enara's quality culture.
Document management functionality gives the company instant control and visibility of document lifecycles and histories, while integrated in-system training has removed the 'headache' of the manual processes.
On-time training completion now routinely hits 90%, with team members across the business engaging with Qualio and even asking for completion of external training to be added to their records.
It's almost impossible to quantify how much time Qualio has saved us - because it's impossible to know how much we were wasting before.
I don't have to convince anyone to use Qualio. They come to me. And that's a reflection of the benefits everyone is receiving from using it.
Connecting the company to a single, cloud-based quality platform has allowed processes to be standardized and sharpened with ease, giving Kate confidence in the company's ability to face future regulatory audits.
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