VitaCyte uses Qualio to manufacture highly purified cell recovery reagents
公司规模
11-200
地区
- America
国家
- United States
产品
- Qualio
技术栈
- eQMS
- Data Encryption
实施规模
- Enterprise-wide Deployment
影响指标
- Customer Satisfaction
- Digital Expertise
- Productivity Improvements
技术
- 应用基础设施与中间件 - 数据交换与集成
- 网络安全和隐私 - 安全合规
- 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
- 监管合规监控
服务
- 系统集成
- 培训
关于客户
VitaCyte is a biotechnology company that manufactures high-purity tissue dissociation enzymes and cell recovery reagents, including collagenase. The company’s product portfolio is designed to correlate optimal enzyme activity with specific cell and tissue types to maximize viable cell yields. VitaCyte, which was founded in 2004 and is headquartered in Indianapolis, has 11 employees. The company operates in the niche regenerative medicine and cell therapy space, focusing on the preparation of cells for human transplant therapies. VitaCyte's products are used in an evolving regulatory environment, necessitating a robust quality management system to ensure compliance and operational efficiency.
挑战
VitaCyte began as an early-stage startup funded by an NIH grant as it pursued a commercialization path for reagents used for the recovery of cells used in human transplant therapies. From the outset, the VitaCyte team knew they would need a robust quality management system to achieve their goals. But with limited resources, that wasn’t really practical. So they built a paper-based system from the ground up knowing that they’d have to eventually migrate to something more sophisticated. VitaCyte manufactures ancillary reagents that are used in the preparation of cells, operating in an evolving, yet-to-be-fully defined regulatory space. Recently, the company was audited by a customer’s quality team, and the experience led VitaCyte to begin the process of searching for a new quality management system.
解决方案
As VitaCyte began looking for a new solution, they examined a few eDoc platforms and found that most of them were feature-heavy and rigid, catering to established pharmaceutical businesses and manufacturers of already-certified materials. After exploring their options, VitaCyte ultimately decided that Qualio, the electronic quality management system (eQMS) built for medical device, biotech, and pharma companies, was best-suited for their needs. Qualio provided a powerful and adaptable quality management system that met VitaCyte's specific requirements. The platform offered seamless onboarding, with high-touch support from the Qualio team, enabling VitaCyte to migrate all their existing documents quickly. Qualio's system adopted VitaCyte's existing numbering and organization conventions, ensuring a smooth transition. Additionally, Qualio's secure and reliable architecture, with data encryption in transit and at rest, provided VitaCyte with the necessary security for their trade secrets.
运营影响
数量效益
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