From paper to digital biotech quality in 3 months
Vector BioMed is a Maryland-based manufacturer of lentiviral vectors used in gene therapies and medicines.
As a biotech manufacturer, cGMP compliance and a strong, integrated quality management system are crucial operational requirements.
Vector BioMed's quality team, led by Quality Assurance Specialist Bennett Klusas, wanted to adopt a fully digitized quality approach, leapfrogging the limitations and eventual operational ceiling of their paper-based set-up.
Embedding ALCOA++ data integrity was a key consideration, as was eliminating the physical footprint and manual demands of paper.
Critically, Vector BioMed wanted to digitize fast - setting themselves an implementation deadline of just 3 months to balance their project with the start-up and commissioning of their manufacturing facility.
An easy-to-use platform with rapid validation was therefore critical.
A large part of our rationale lay in how Qualio struck the best balance of off-the-shelf functionality with what ways we could adapt it to our needs.
Because it's GAMP Category 4, Qualio really functions like a box of Lego - the parts are already validated and suitable for use, and you just put them together how you want.
The Vector BioMed team conducted a detailed search of the eQMS market, led by some key scoping questions:
How flexible is the system?
How responsive and supportive is the vendor?
Does the software meet all our operational requirements?
What does the future product roadmap look like?
Qualio answered these questions and more.
Crucially, adding Qualio+ to their subscription would allow Vector BioMed to access a range of pre-built, ready-to-go system content which would accelerate their go-live speed even further.
The company signed on the dotted line in mid-2023.
The Qualio team got to work immediately to hit Vector BioMed's 3-month deadline.
Within 1 month, Bennett had been trained on Qualio, had attended a range of extra webinars, and had identified his favorite functionality: document tagging and smart links.
A group of internal stakeholders was assembled by Bennett to ensure Qualio met the needs of as many corners of the business as possible.
Within 2 months, the first few documents had been migrated into Vector BioMed's shiny new eQMS, with department heads trained and 'power user' champions identified to spread awareness.
Qualio's done awesome work and done well by us.
3 months from picking the system to implementation is something I could not have imagined prior to this position.
Qualio's best-practice validation approach took the weight of extra testing off Bennett's team, allowing them to focus on reviewing and approving their supplied validation documents and qualifying Qualio as a supplier.
Vector BioMed's roll-out ultimately completed exactly according to schedule. Existing documents were migrated and supplemented with Qualio+ document templates. Workflows for training, deviations, CAPAs, change requests and supplier qualifications were built and tested, and both live and sandbox testing accounts made available to all Vector BioMed staff.
Crucially, the company's Qualio project was right-first-time, with 0 major reworks required and a robust, fully digital quality system in place for managing documentation, training, suppliers and quality events.
The fast and effective roll-out of their eQMS allowed Vector BioMed to proceed to their next exciting chapter: the completion of their first GMP production in November 2023!
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