Medicines360 Takes Control of Regulated Content with Vault QualityDocs
Company Size
11-200
Region
- America
Country
- United States
Product
- Veeva Vault QualityDocs
Tech Stack
- Cloud-based technology
Implementation Scale
- Enterprise-wide Deployment
Impact Metrics
- Customer Satisfaction
- Digital Expertise
- Productivity Improvements
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
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 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.
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
Case Study missing?
Start adding your own!
Register with your work email and create a new case study profile for your business.
Related Case Studies.
Case Study
Case Study: Pfizer
Pfizer’s high-performance computing software and systems for worldwide research and development support large-scale data analysis, research projects, clinical analytics, and modeling. Pfizer’s computing services are used across the spectrum of research and development efforts, from the deep biological understanding of disease to the design of safe, efficacious therapeutic agents.
Case Study
Hospital Inventory Management
The hospital supply chain team is responsible for ensuring that the right medical supplies are readily available to clinicians when and where needed, and to do so in the most efficient manner possible. However, many of the systems and processes in use at the cancer center for supply chain management were not best suited to support these goals. Barcoding technology, a commonly used method for inventory management of medical supplies, is labor intensive, time consuming, does not provide real-time visibility into inventory levels and can be prone to error. Consequently, the lack of accurate and real-time visibility into inventory levels across multiple supply rooms in multiple hospital facilities creates additional inefficiency in the system causing over-ordering, hoarding, and wasted supplies. Other sources of waste and cost were also identified as candidates for improvement. Existing systems and processes did not provide adequate security for high-cost inventory within the hospital, which was another driver of cost. A lack of visibility into expiration dates for supplies resulted in supplies being wasted due to past expiry dates. Storage of supplies was also a key consideration given the location of the cancer center’s facilities in a dense urban setting, where space is always at a premium. In order to address the challenges outlined above, the hospital sought a solution that would provide real-time inventory information with high levels of accuracy, reduce the level of manual effort required and enable data driven decision making to ensure that the right supplies were readily available to clinicians in the right location at the right time.
Case Study
Gas Pipeline Monitoring System for Hospitals
This system integrator focuses on providing centralized gas pipeline monitoring systems for hospitals. The service they provide makes it possible for hospitals to reduce both maintenance and labor costs. Since hospitals may not have an existing network suitable for this type of system, GPRS communication provides an easy and ready-to-use solution for remote, distributed monitoring systems System Requirements - GPRS communication - Seamless connection with SCADA software - Simple, front-end control capability - Expandable I/O channels - Combine AI, DI, and DO channels
Case Study
Fusion Middleware Integration on Cloud for Pharma Major
Customer wanted a real-time, seamless, cloud based integration between the existing on premise and cloud based application using SOA technology on Oracle Fusion Middleware Platform, a Contingent Worker Solution to collect, track, manage and report information for on-boarding, maintenance and off-boarding of contingent workers using a streamlined and Integrated business process, and streamlining of integration to the back-end systems and multiple SaaS applications.
Case Study
Driving Digital Transformations for Vitro Diagnostic Medical Devices
Diagnostic devices play a vital role in helping to improve healthcare delivery. In fact, an estimated 60 percent of the world’s medical decisions are made with support from in vitrodiagnostics (IVD) solutions, such as those provided by Roche Diagnostics, an industry leader. As the demand for medical diagnostic services grows rapidly in hospitals and clinics across China, so does the market for IVD solutions. In addition, the typically high cost of these diagnostic devices means that comprehensive post-sales services are needed. Wanteed to improve three portions of thr IVD:1. Remotely monitor and manage IVD devices as fixed assets.2. Optimizing device availability with predictive maintenance.3. Recommending the best IVD solution for a customer’s needs.
