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Medicines360 Takes Control of Regulated Content with Vault QualityDocs
Technology Category
- Application Infrastructure & Middleware - Data Exchange & Integration
- Platform as a Service (PaaS) - Connectivity Platforms
Applicable Industries
- Healthcare & Hospitals
- Pharmaceuticals
Applicable Functions
- Product Research & Development
- Quality Assurance
Use Cases
- Regulatory Compliance Monitoring
- Remote Collaboration
Services
- Cloud Planning, Design & Implementation Services
- System Integration
The Challenge
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.
About The Customer
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.
The Solution
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.
Operational Impact
Quantitative Benefit
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