Kalypso Accel for RIM
Kalypso provides life sciences companies with a cost-effective accelerator for a RIM system implementation - Accel for RIM. The solution enables an integrated platform to effectively manage and track product registrations, accelerate and improve the submissions accuracy, manage global UDI information, and enable efficient product distribution. It consolidates compliance and quality data from various enterprise solutions into a global source of truth for product registrations and tracking to accelerate regulatory submissions. Deployed using modern APIs to aggregate product data, regulatory documentation and submission packages. Pre-configured for rapid implementation with a validated software system. Based on industry-leading RIM practices and implementations.
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SAI360
The most powerful, agile approach to risk management. The decisions you make today can help mitigate the risks you may encounter tomorrow. SAI360 is cloud-first software and modern ethics and compliance learning content designed to help your organization effectively navigate risk with a flexible, agile approach. Intelligent solutions, global expertise all in one award-winning platform.
Solution configurability, extensible data model with configurable UI/forms, fields, relationships to extend solutions. Process modeling, easily modify or create new processes to automate and streamline risk, compliance, and audit activities. Data visualization and analysis, many out of the box and easy to configure dashboards to visualize and analyze data. Learning and best practice content – preloaded frameworks, control libraries, and regulatory content along with values-based ethics and compliance learning content. System integration – Integration framework with APIs and other protocols.
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Quality Connect
Enterprise Quality Management Software in the cloud for the life sciences. In today’s complex operational environment, technology plays a vital role in ensuring that QA is made aware of the issues as they happen. Gaining insight into the performance of your quality management system and the current state of your operation helps you to be more proactive, which minimizes risk and eliminates costly delays. Montrium has designed its Enterprise Quality Management system (EQMS) to enable life science companies to tackle the quality challenges that they face in content management head-on. All of our SharePoint QMS modules can be used independently or together as a fully integrated quality management system. These modules are available as part of our Montrium Connect Platform and can be deployed on-premise or in the cloud. Perfect for pharmaceutical companies, contract manufacturing organizations, medical device companies. Built to achieve compliance with GMP and GCP requirements.
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Qualio
Qualio is an all-in-one quality and compliance management platform built for small and growing businesses in life sciences and healthcare. Reliable, affordable, and easy to use, Qualio helps companies building life saving products get to market faster by reaching 100% ISO, GxP, and FDA compliance. With Qualio, companies can conveniently manage document control, training, CAPAs, NCRs, audits, suppliers, complaints, and more in one platform.
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