SAI360
Risk management is best done in a fluid and powerful way. Your decisions today can help you mitigate the risks that you might face tomorrow. SAI360 is a cloud-first software that combines modern ethics and compliance content to help organizations navigate risk in a flexible and agile way. All the best in intelligent solutions and global expertise in one platform.
Configurability of solution, extensible data model with configurable interface/forms, fields and relationships to extend solutions. Process modeling: Modify or create new processes to automate, streamline, and reduce risk, compliance, audit, and other activities. Data visualization and analysis. Many pre-configured dashboards that are easy to set up allow you to visualize and analyze data. Learning and best practices content - Preloaded frameworks, control library and regulatory content, along with values-based ethics, compliance learning content. Integration framework with APIs, and other protocols.
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Rimsys
Rimsys provides a single, cloud platform for end-to-end regulatory process digitization and automation. Designed by and for regulatory affairs professionals, Rimsys helps medtech companies reduce repetitive administrative work, speed time to market, respond faster to changing regulations, and drive alignment across internal teams, affiliates, and partners.
Only Rimsys provides a holistic platform that supports a full range of regulatory activities. Use regulatory intelligence and digital templates to guide regulatory strategy and streamline submissions. Create compliant, submission-ready content, and consolide PDF packages for electronic and print submissions. Digitally collect and maintain evidence of compliance. Link to relevant standards and get notified of changes. Get notified of changing standards, laws, regulations, and guidance documents that impact your products. Create self-service application, product, and country reports to see exactly where your products can be sold and their current registration status.
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MasterControl
It can seem like a never-ending series of tradeoffs to bring breakthrough products to market within highly regulated industries. MasterControl's GxP software simplifies workflows, so you don't have to compromise quality for cost or innovation with regulation.
Complete and connected meets flexible and fast. MasterControl Quality Excellence transforms quality data and processes to a competitive edge.
Modern software is the first step in modernizing your manufacturing operations. MasterControl Manufacturing Excellence, from work orders to production records (EBR/eDHR), to logbooks and work instructions, is the easiest way to digitalize manufacturing.
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Ennov RIM
Imagine all your regulatory information about products, registrations and submissions, correspondence, and commitments in one central place, accessible from anywhere. Ennov RIM allows life sciences companies to streamline their regulatory processes, improve data quality, quickly respond to business-critical questions, and effectively responds to health authority requests. Ennov RIM, a purpose-built application based on Ennov Process, allows for the tracking and management of therapeutic product details as well as registration information. Ennov RIM gives regulatory personnel the essential information and functionality they need to manage product portfolios globally, whether you're planning to launch a new product or handle variations to existing registrations.
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