Veeva Japan Product Lineup

The traditional publishing process is essentially fragmented, with each process arranged in a linear sequence. In this process, document management systems and publishing tools, along with multiple spreadsheets, are used for planning and progress management. The gaps between these different systems lead to inefficiencies and can easily cause delays in planning. "Veeva Vault Submissions Publishing" offers a completely different approach. By integrating publishing capabilities into the Vault RIM suite, it provides a parallel and continuous publishing process that dramatically accelerates the speed of submissions. [Benefits] ■ Improved efficiency ■ Simplified procedures ■ Increased speed *For more details, please refer to the PDF materials or feel free to contact us.

• Software (middle, driver, security, etc.)
• Integrated operation management
• Document and Data Management

"Veeva Vault Submissions" is a cloud application that enables the creation and management of submission content for regulatory authorities. By using it, life sciences companies can enhance access, visibility, and management of their submission information as a whole. Content creators can securely access and submit documents anytime, anywhere, and from any device. Additionally, through a global system, companies can better manage the documents submitted to local authorities by their affiliated companies in various regions. 【Features】 ■ Groundbreaking usability ■ Real-time status tracking ■ Available for companies of various sizes ■ Scalable content model ■ Submission binder templates *For more details, please refer to the PDF materials or feel free to contact us.

• Software (middle, driver, security, etc.)
• Integrated operation management
• Document and Data Management

The "Veeva Vault Submissions Archive" allows access to application documents and correspondence with authorities from anywhere in the world. With a high-performance cloud architecture, authorized users can quickly and easily access published application documents. Partner companies can download and reuse application documents and content, as well as upload documents submitted to local authorities. Additionally, it is possible to import application documents directly from file sharing while maintaining the eCTD XML backbone, folder structure, and hyperlinks between documents. 【Benefits】 ■ A globally trusted source ■ Presenting the right content to the right people ■ Accelerating responses to authorities ■ Improved agility *For more details, please refer to the PDF materials or feel free to contact us.

• Software (middle, driver, security, etc.)
• Integrated operation management
• Document and Data Management

The "Veeva Vault Clinical Data Management Suite (CDMS)" is an integrated suite equipped with EDC, data cleansing, coding, and review functions. It manages everything from study setup to execution, allowing for complete and up-to-date visibility of data within the same clinical trial. By fundamentally rethinking traditional data management systems and processes, it accelerates clinical trial schedules. Additionally, the flexible and free-format data display optimized for monitoring/review enhances the efficiency of data cleansing and reduces the time to database lock. 【Benefits】 ■ Shortens the cycle time of clinical trials ■ Flexibly conducts desired clinical trials ■ Quickly provides clean data *For more details, please refer to the PDF materials or feel free to contact us.

• Software (middle, driver, security, etc.)
• Other embedded systems (software and hardware)
• Integrated operation management

"Veeva Vault Study Startup" is an application for clinical trial startup that automatically shares related documents generated during the eTMF and clinical trial startup processes without going through complex integration tasks. Once managed, the related documents for clinical trial startup can be utilized and accessed in various environments. This single source of information enhances visibility and manageability, maximizing the subject recruitment period and helping to shorten the time required for site activation. It connects teams around the world, implements best practices for managing the clinical trial startup processes in each country and site, and reduces the time to site activation. [Features] ■ A single source of information through interoperability with eTMF ■ Single system ■ 100% visibility *For more details, please refer to the PDF materials or feel free to contact us.

• Other embedded systems (software and hardware)
• Software (middle, driver, security, etc.)
• Other information systems

"Veeva Vault Registrations" is a single global application that manages product approval information, records of communication with authorities, and the management of commitments. With this product, companies can manage application and approval information for their entire product portfolio and interactions with authorities. It provides visibility across the organization as a shared resource for headquarters, affiliates, and partner companies, enabling regulatory teams to make informed decisions quickly. [Benefits] ■ Global visibility ■ Improved data quality ■ Enhanced agility ■ Faster response to authorities *For more details, please refer to the PDF document or feel free to contact us.

• Other embedded systems (software and hardware)
• Software (middle, driver, security, etc.)
• Other information systems

"Veeva Vault QualityDocs" is a single secure application that allows internal users and partners to create managed documents, collaboratively review them, and approve them. With its user-friendly interface and cloud access, this solution can be implemented across various departments, clinical trial sites, partners, and even infrequent users, reducing the overall risk of non-compliance. The cloud model facilitates direct access for all stakeholders to a single source of truth, while also providing cost-effectiveness. 【Features】 ■ Always new, not bound by old functionalities ■ Flexible workflows ■ Read and Understood feature ■ Watermarking and overlays ■ Document change management *For more details, please refer to the PDF materials or feel free to contact us.

• Other embedded systems (software and hardware)
• Software (middle, driver, security, etc.)
• Other information systems

Veeva Vault QMS is an easily accessible cloud-based quality management solution. It provides best practice processes for proactive quality management through deviations, internal audits, external audits/inspections, complaints, research facility investigations, and change management. With a new consumer web interface, the product can be intuitively operated with minimal support, increasing user adoption rates. **Benefits** - Global alignment with partners - Complete visibility of quality management processes - Improved compliance - Reduced time to operational improvements *For more details, please refer to the PDF document or feel free to contact us.*

• Other embedded systems (software and hardware)
• Software (middle, driver, security, etc.)
• Other information systems

"Veeva Vault CTMS" is a cutting-edge cloud application. It facilitates the integration of clinical trial information and processes for life sciences companies, achieving efficiency in clinical trial management and complete visibility across the entire clinical trial portfolio. It is a seamless, single system that enables record creation and simple navigation throughout the entire clinical trial process, thereby improving operational efficiency and enabling faster and higher-quality clinical trials. [Benefits] - Accelerated clinical trials - Improved decision-making - Streamlined clinical operations *For more details, please refer to the PDF materials or feel free to contact us.

• Other embedded systems (software and hardware)
• Software (middle, driver, security, etc.)
• Other information systems

This product is an application that simplifies and standardizes post-market surveillance of medical devices, improving the safety, reliability, and quality of the products. Rapid reporting of adverse events is ensured through fully automated electronic reporting to authorities and the output of written submission documents. Seamless integration with quality and regulatory processes enables proactive complaint handling throughout the entire product lifecycle, accelerating continuous innovation. 【Features】 ■ Global reporting obligation determination tree ■ Reporting deadline management ■ Automated adverse event reporting ■ Interactive dashboard and reports ■ Customizable adverse event management workflow ■ Part of Veeva Vault Quality Suite *For more details, please refer to the PDF materials or feel free to contact us.

• Other embedded systems (software and hardware)
• Software (middle, driver, security, etc.)
• Other information systems

The "Veeva Vault Training" is an application that seamlessly integrates with "Vault QMS" and "Vault QualityDocs" to streamline the process from the creation to the delivery and completion of training. Quality management events on "Vault QMS" automatically execute tasks within this product and assign them based on job duties and roles. Centralized training records and a single audit trail make it easier to demonstrate compliance, reducing preparation time for audits and maintaining a state of readiness for inspections at all times. 【Benefits】 ■ Qualification management ■ Improved training compliance ■ Integration of quality management ■ Maintaining readiness for audits and inspections *For more details, please refer to the PDF document or feel free to contact us.

• Other embedded systems (software and hardware)
• Software (middle, driver, security, etc.)
• Other information systems

Amidst the rising demands on the manufacturing industry, digitalization is accelerating. As supply chains become more complex and the transition to equipment that enables the production of a wide variety of products progresses, companies are working on transforming their operations to achieve agility. 'Veeva Vault Station Manager' is an easy-to-use, new mobile application for manufacturing sites. It ensures that the right content is always available, helping to improve compliance and efficiency. 【Features】 ■ Always access new content at various locations on the manufacturing floor ■ Operators can quickly find and access the appropriate information ■ Improved compliance ■ Centralized management and tracking of quality control content for each manufacturing site and device *For more details, please refer to the PDF document or feel free to contact us.

• Other embedded systems (software and hardware)
• Software (middle, driver, security, etc.)
• Other information systems

"Veeva Vault eTMF" is a clinical application that provides a real-time preparation system for audits and inspections, complete visibility of TMF progress, and access for all partners involved in the trial execution. With this product, sponsors can manage trials more effectively by accurately understanding the situation. Trial execution personnel and CROs can experience the flexibility and usability essential for operations in accordance with SOPs and efficient eTMF input. It elevates the quality, accessibility, visibility, and usability of TMF to a high standard. 【Features】 ■ Real-time inspection preparation system ■ Complete visibility ■ Accessible anytime ■ User-friendly operability ■ Quick operational startup *For more details, please refer to the PDF materials or feel free to contact us.

• Other embedded systems (software and hardware)
• Software (middle, driver, security, etc.)
• Other information systems

"Veeva Vault Payments" is a clinical cloud application that accelerates payments to clinical trial sites and provides complete visibility into payment information for all clinical trial partners. With seamless integration with "Vault CTMS," sponsors and CROs can streamline the payment process within their existing clinical trial management workflows. Enhanced visibility and accuracy enable timely payments to trial sites. It features comprehensive functions such as identifying payment accounts, tracking at the clinical trial and site levels, and creating payment invoices, and it can also integrate with accounts payable systems for payment execution. [Features] ■ Centralized information management ■ Customizable cost structure templates ■ Generation of payment accounts ■ Creation of payment invoices ■ Integration with Vault CTMS *For more details, please refer to the PDF document or feel free to contact us.

• Other embedded systems (software and hardware)
• Software (middle, driver, security, etc.)
• Other information systems