Qvella needed validation software, an FDA-compliant system, and advanced manufacturing
Irvine, CA – April 25, 2022 – Qvella Corp., a fast-growing medical device manufacturing company based in Richmond Hill, ON, is deploying OptiProERP with SAP Business One as its platform for rapid growth.
A molecular diagnostics company, Qvella has developed technology that enables the rapid detection of infectious agents in a direct blood sample.
“We needed an ERP system that could handle the complexities of our products, meet our regulatory compliance, and that can truly scale up with us as we grow our business. Having the right ERP system as a core piece of our operational foundation is critical to managing high growth and our ultimate success.”
– Michael Fricker, CFO, Qvella Corp.
Now that one of its products is transitioning from beta into full-scale commercial production, Qvella executives needed an ERP as a critical foundation that would allow the company to successfully scale in a big way, Fricker said.
“This is even more so the case in a field as regulated as medical devices where process, documentation and traceability are mission critical,” he added. “Before that didn’t make sense, but now that we are launching our FAST PrepTM product, we knew the time was now.”
Founded in 2009, Qvella has raised $40 million from individuals and venture capital firms in two rounds. The company, with 90 employees and additional offices in Carlsbad, California and Mechelen, Belgium, wants to shorten diagnosis timeframes and lower costs in an attempt to save lives.
Qvella’s FAST technology utilizes a novel technique that enables the rapid isolation, concentration, and detection of infectious agents in a direct blood sample. Rather than using culture methods and learning results in 3 days, Qvella delivers results up to 24 hours faster. It successfully completed beta trials of its FAST-Prep™ PBC technology at healthcare centers in the U.S. and Europe last year.
Complex Manufacturing and Traceability
While Qvella looked at a number of other ERPs including Acumatica Cloud ERP, none could meet all the regulatory and advanced manufacturing functionality that OptiProERP provided.
“We needed an ERP system that would handle complex manufacturing processes and BOMs, provide a high level of traceability while also meeting all regulatory standards such as FDA and MDSAP in an ISO13485 environment,” Fricker said.
“OptiProERP with SAP Business One seemed to be a combination of advanced manufacturing processes and strong financial controls, two areas that were key. OptiProERP was also able to meet all of the traceability needs and satisfy international regulations,” he added.
OptiProERP offers a single, complete business management solution for manufacturers and distributors that includes financials, CRM, sales, inventory management, warehouse management, manufacturing, shop floor execution, and shipping all in one solution. As SAP Business One’s strategic industry and OEM partner for manufacturing and distribution, OptiProERP’s industry-specific solutions are seamlessly built into and integrated with SAP Business One’s core ERP and financial modules.
Qvella has a seasoned management team that has used many ERP systems. “Very few that we seriously considered could come even close to OptiProERP’s capabilities,” said Fricker.
Software Validation by Sister Company, GMP Validation
In addition to SAP Business One and powerful manufacturing functionality, Qvella also plans to implement GMP Validation Center’s Software Validation Services.
An OptiProERP sister company, GMP Validation helps pharmaceutical, biotechnology, and other healthcare companies comply with FDA-mandated regulations and ongoing testing and documentation for manufacturing and commercialization processes to ensure device and drug quality, effectiveness, and safety.
The sister companies can help manufacturers like Qvella save time and costs since the two are integrated and versed in serving medical device and life science companies. Having implemented and validated ERP solutions concurrently for a large portfolio of customers with combined project teams and out-of-the-box templates, their software and FDA validation methodology provides a leaner approach than the model of completely separate companies operating with two fully staffed and separate teams, which requires more overhead and project management.
Qvella chose OptiProERP because the team spent time to understand the business and the system was user-friendly, offered multiple critical reports, and came with robust out-of-the-box functionality. “We also appreciated that they respected our budgetary constraints, demonstrating to us that they understand what it takes to work with earlier stage businesses,” Fricker said.
Internal Implementation Team Valuable
Qvella also liked that OptiProERP has its own implementation team, which they said was a big advantage over other providers such as Acumatica, which depends on Value Added Resellers (VARs) and third parties to implement its solutions.
“In the end, we felt that the Acumatica system wasn’t as well positioned to meet Qvella’s manufacturing needs, which are significantly complex, while also accommodating our traceability requirements,” Fricker said. “The OptiProERP implementation teams actually invest in the success of the implementation, walks you through getting it right, and have an unlimited knowledge of the product. VARs often struggle with that.”
Because Qvella develops medical devices that contribute to improved patient outcomes, the company feels a great deal of responsibility and pressure to make sure its devices deliver, every time.
“Having the right ERP system as a core piece of our operational foundation is critical to managing high growth and our ultimate success,” said Fricker. “We’re excited to begin work with OptiProERP and are highly confident their system will meet all of our challenges.”
OptiProERP is an industry-leading ERP solution for manufacturing and distribution. OptiProERP delivers best-in-class industry-specific functionality embedded into SAP Business One, the market-leading business management platform for small and midsize enterprises. Customers gain an end-to-end business management solution, including financials, accounting, sales, CRM, and industry-specific functionality that fully leverages deep industry expertise of over 20 years dedicated to serving manufacturers and distributors.
OptiProERP is an eWorkplace Manufacturing solution. eWorkplace Manufacturing is SAP’s strategic industry partner for manufacturing and distribution and its first OEM partner as part of SAP’s global PartnerEdge Program. Serving manufacturers and distributors for over 20 years with OptiProERP and BatchMaster as its two ERP solutions, eWorkplace Manufacturing has gained the trust of over 3,000 customers globally.
Sudi Gummi, firstname.lastname@example.org
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