ViSU Description
ViSU™, a cloud-based End-to End Regulatory Information Management platform (RIM), is specifically designed for the medical device industry. It allows global users to access and manage regulatory data (Product Master and Registrations, Tracking), Dossiers/Tech files (Submission planning and building & lifecycle), HA/NB correspondence and Obligations tracking. ViSU helps you embrace digitalization in regulatory. It provides connectivity, traceability, and automation which leads to regulatory management efficiency, lower compliance risks, and cost reduction.
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Kalypso offers life sciences companies a cost-effective accelerator to implement a RIM system - Accel for RIM. The integrated platform allows for efficient product distribution and management, as well as a global platform to track and manage product registrations. It consolidates compliance data and quality data from different enterprise solutions into one global source of truth to facilitate product registrations and tracking in order to speed up regulatory submissions. Modern APIs are used to combine product data, regulatory documentation, and submission packages. Pre-configured for quick implementation with a valid software system. Based on industry-leading RIM practices.
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Veeva Vault RIM
End-to-end regulatory information management from a single platform. The Vault RIM Suite streamlines global regulatory process on a single cloud-based platform. This allows life sciences companies to increase visibility, data quality, agility, and efficiency. You can respond faster to changes in regulations and improve process efficiency, from submission planning to publication. Coordinate regulatory efforts across HQ and affiliates within a single RIM platform. Assure that teams are creating reliable regulatory content with high data integrity. Veeva Vault Registrations manages product data worldwide, including variations, registration status, and interactions with health authorities. Veeva's flexible data structure supports IDMP data points, and will continue to support changing regulatory data standards. Veeva Vault Submissions automates regulatory process steps and streamlines submission planning.
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Dow Jones Risk & Compliance
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Dot Compliance QMS
Dot Compliance offers the industry's first ready to use Quality Management Solution powered by the Salesforce.com platform. The Dot Compliance solution includes an extensive set of off-the-shelf ready eQMS and compliance pre-configured processes, enabling customers to deploy quickly and cost effectively. Dot Compliance ready to use solutions include full project validation services and product validation packages. Dot Compliance offers the industry’s most cost-effective quality and compliance management solution available, allowing users to quickly deploy flexible and scalable solutions. Automate core quality processes such as Document Management, Training Management, CAPA, Audits, Customer Complaints, Change Management, Supplier Quality, and more. Our solution is fully configurable and offers seamless integration abilities, with easy adaptation and implementation of customer’s specific requirements.
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Integrations
No Integrations at this time
Company Details
Company:
DDi
Year Founded:
1997
Headquarters:
United States
Website:
www.ddismart.com
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Product Details
Platforms
SaaS
Type of Training
Documentation
Live Online
In Person
Customer Support
Phone Support
24/7 Live Support
ViSU Features and Options
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