Medicines360 Takes Control of Regulated Content with Vault QualityDocs
公司规模
SME
地区
- America
国家
- United States
产品
- Veeva Vault QualityDocs
技术栈
- Cloud-based technology
实施规模
- Enterprise-wide Deployment
影响指标
- Productivity Improvements
- Digital Expertise
- Customer Satisfaction
技术
- 平台即服务 (PaaS) - 连接平台
适用行业
- 医疗保健和医院
- 药品
适用功能
- 质量保证
- 产品研发
用例
- 监管合规监控
- 远程协作
服务
- 云规划/设计/实施服务
- 系统集成
关于客户
Medicines360 is an innovative, global nonprofit, women’s health pharmaceutical company with a mission of expanding access to quality medicines, regardless of socioeconomics, insurance coverage, or geographic location. The U.S. Food and Drug Administration (FDA) recently approved Medicines360’s Liletta™ (levonorgestrel), a hormonal intrauterine device (IUD). The company is now ramping up commercialization of its new product. Medicines360 relies heavily on geographically dispersed teams and partners. With only email, file share, and a paper-based system, it was challenging to control and securely share regulated content. It was also not feasible for remote employees or contractors to come into the office when they needed to refer to a standard operating procedure (SOP) or other regulated document.
挑战
Medicines360, a nonprofit pharmaceutical company, was facing challenges in controlling and securely sharing regulated content among its geographically dispersed teams and partners. The company was heavily reliant on email, file share, and a paper-based system, which made it difficult for remote employees or contractors to access standard operating procedures (SOPs) or other regulated documents. As the company was transitioning from research and development to launching and commercializing its first product, it was struggling with complex and inefficient processes for developing, reviewing, approving, and tracking training of controlled documents. Without a single document management system that was easily accessible from anywhere, the company lacked a consistent and efficient way to distribute controlled content and track SOP training to ensure compliance.
解决方案
Medicines360 implemented Veeva Vault QualityDocs, a cloud-based, advanced content management technology. The solution met all the company's requirements, including an intuitive user interface, robust audit trail, compliant electronic signatures, and validation support. Vault QualityDocs is accessible from any major web browser, allowing users to easily learn and access the application from anywhere. The solution also provides true multitenant cloud and validation-ready software updates, ensuring that Medicines360 is always on the latest release. The ability to seamlessly view PDF documents removed the infrastructure complexity and connection challenges experienced with other applications. The implementation of Vault QualityDocs was completed faster than expected due to its native life sciences-specific functionality, including preconfigured quality workflows and document taxonomy. The solution's cross-browser, cross-platform functionality allows Medicines360 to easily collaborate with different functional areas and share best practices in real time.
运营影响
数量效益
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