Verve Puts Digital-First Quality
at the Heart of Its QC Lab

The views expressed in this customer story are based on the experience of Por Bjerke, senior manager of internal QC operations at Verve Therapeutics, and do not necessarily reflect the views of Verve Therapeutics.

Founded in 2018, Verve’s operating model initially relied on external manufacturing and quality control (QC). While preparing one of its products for the clinical stage, it calculated that moving test methods in-house would reduce turnaround times and help it to scale faster; so, it built a lab and internal QC expertise and has been diligently transferring methods for in-house execution.

Verve wanted its new lab to be paperless from the start, and bring together internal and external testing for improved efficiency. To achieve its goals, the company implemented Veeva LIMS to unify its quality assurance (QA) and QC processes, reduce its reliance on manual processes, and improve right first time.

Applying startup thinking to lab QC

After deciding to build its own lab, the race was on to get operational quickly and cost-effectively. As a startup function, the QC team needed to collaborate with QA to demonstrate GMP compliance but faced constraints within its existing tools, including a stand-alone, research-centric, unvalidated electronic laboratory notebook (ELN). Por Bjerke, senior manager of quality control internal operations, explains: “To achieve our goals quickly, we needed to migrate from paper, avoid transcription errors, and eliminate the time spent creating physical logbooks.”

With complex new RNA technologies to learn about, Verve couldn’t afford any distractions from the science. It needed a GMP-compliant LIMS that was intuitive enough to use routinely without significant analyst training or a large IT footprint. Otherwise, the lab would struggle to achieve scale as it moved product candidates through the clinical stage and the number of trials, release markets, and manufactured batches rapidly increased.

Verve realized that using one system for test method execution and traditional LIMS capabilities would be a game-changer for lab productivity. By simplifying the user experience, analysts can complete their work accurately and efficiently, improving right first time.

The case for cloud-based LIMS

Larger biopharmas often employ dedicated teams to manage their on-premise system maintenance and IT infrastructure. As a biotech, Verve was able to think differently and adopted Veeva LIMS for a cloud-first strategy from the early clinical stage of product development.

Selecting a cloud-based LIMS shifts the ownership and scalability of the solution’s infrastructure to the cloud provider. Instead of building and maintaining technology systems, Bjerke’s team focuses on its core work of writing and executing tests, evaluating the results, and managing lab resources. “We’re able to own the system ourselves, whereas IT is there for support if we have any questions,” says Bjerke. “Veeva’s combined expertise in programming and knowledge of compliance and biotech makes for a strong partnership.”

Veeva LIMS capabilities unify QA and QC and result in a closer partnership with manufacturing. The lab can move quickly from receiving a sample to testing and approving the results, which are then visible to the lab’s external QC counterparts in the certificate of analysis (CoA). Once external QC inputs the data from external testing labs, QA is automatically notified to perform their review and release of the batch.

Part of the rationale for choosing Veeva LIMS is its interoperability with other Veeva quality applications. Verve, for example, already used Veeva QMS, QualityDocs, and Training. Combined with Veeva LIMS, this ensures that QC teams are always working from the right version of their test method procedure. Veeva LIMS also speeds up user adoption by providing a familiar user experience. “Having LIMS connected to QMS and Training ensures only people who are appropriately trained can run the assay,” notes Bjerke.

Working on the same platform means manufacturing partners can access the current version of a CoA for a drug substance, which the supplier may require. Having the information readily available in the system mitigates the risk of shipment delays. “Instead of emails back and forth, or popping by someone’s desk and they are not there, people can really work from anywhere. They get the notifications right away, so there is no time lost,” explains Bjerke.  

Laser focus on right first time

Verve anticipates a significant improvement in right first time by reducing the impact of human error. Built-in process and data verification checks, and audit trails, within Veeva LIMS can flag possible numerical typos, missing information, and calculation mistakes, reducing the back-and-forth within teams to confirm data integrity and correctness.

“During reviews within our manual paper process, most documentation is rejected due to typos, rounding, and calculation errors. We expect an improvement in initial approval from the use of Veeva LIMS because the system will reduce transcription error and automate calculations,” says Bjerke.

Working with Veeva, Verve has enabled key performance indicators (KPIs) in the system that pull through automatically into reporting: for example, the time from sample receipt to testing and approval. Soon, the team will start tracking metrics to identify bottlenecks and their causes. Bjerke explains, “We’ll be able to see which piece is taking the longest: Is it the method or the science? Do we have too many tasks? Or is it not knowing which samples to prioritize?”

Verve is excited to optimize their capabilities through Veeva LIMS, which offers many features including capturing test method data, equipment and reagents, and automatically generating certificates. Having test method procedures viewable within Veeva LIMS speeds up execution as analysts know exactly which information to record. Future capabilities include connecting QMS to samples and improving data search for laboratory investigations.

Close collaboration has helped to get the right configuration for Verve. “We are designing the system with the end game in mind, so it is out of the box rather than custom configured,” Bjerke says. “We’re able to grow with the system and while we grow, we can incorporate the other modules that Veeva has.”

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