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Alphazyme Uses Qualio to Produce Molecular Enzymes at Scale for Biotech Companies
技术
- 应用基础设施与中间件 - 数据交换与集成
- 功能应用 - 企业资源规划系统 (ERP)
适用功能
- 商业运营
- 质量保证
用例
- 过程控制与优化
- 监管合规监控
- 远程协作
服务
- 系统集成
- 培训
挑战
In 2005, Benoit founded a life sciences company called Enzymatics, which has since been acquired by QIAGEN. After an early customer sent over an 18-page supplier evaluation form and asked for a site visit to further explore their products and processes, Benoit realized the company needed to rapidly implement a robust quality management system. At the time, electronic QMS systems were rare, not user-friendly, and costly, so the Enzymatics team established a paper-based system—a decision that turned into a learning experience. Seeking to avoid a similar problem in his new venture, the Alphazyme business plan called for a paperless, ISO 13845-compliant quality system architecture from the get-go.
关于客户
Alphazyme is a biotechnology manufacturer headquartered in Jupiter, Florida that produces custom enzymes used by large-scale biotech companies to read, write, and edit DNA molecules. Founded in 2018 by CEO Christopher Benoit—a serial entrepreneur and expert in the enzyme development and production space—Alphazyme has grown steadily over the last 18 months as it helps biotech firms accelerate cutting-edge applications in DNA literacy technologies. The company has a strong focus on innovation and quality, aiming to provide high-quality enzymes that meet stringent regulatory standards.
解决方案
Right after Stephana Petrino was hired as the Vice President of Quality at Alphazyme, she was tasked with finding an eQMS that met these requirements. Because the young company needed to operate with agility, the right system would also need to be flexible. Petrino examined roughly 15 solutions and had sales discussions with eight vendors. After thoroughly assessing the options, Alphazyme selected the Qualio product and embarked on a process of building its quality system inside the system - from the ground up. “We needed something that was user-friendly, easy to onboard new team members, and easy to get up and running,” Petrino says. “Qualio has surpassed our expectations on those metrics.”
运营影响
数量效益
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