RegDesk is the most comprehensive AI-enabled RIMS platform for Medical Devices, Pharmaceuticals, and IVD companies.
• Our proprietary Regulatory Intelligence for over 120+ countries is translated and accessible in a standard format. In addition, it provides alerts on evolving regulatory changes
• Our AI-powered Application Builder allows RA teams to prepare and publish global applications in 1/10th of the time
• Our Change Assessment capability helps RA teams understand the impact of the change(s) on an existing product(s) and the action required
• Our Distributor Collaboration provides seamless workflow solutions to interact, communicate, and share documents with external business partners
• Our Standards Management makes it easy for RA teams to search and manage not only international but also country-specific standards
• Our Tracking & Reporting functionality allows teams to track regulatory projects across the globe, receive renewal notifications, and generate reports on KPIs within seconds
For more information, visit our website.
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A cloud LIMS that tracks samples, tests results, and manages inventory for life science research, industrial QC labs, and biotech/NGS. Includes regulatory support for CLIA and HIPAA, Part 11 and ISO 17025. The quality, security, traceability, and traceability for samples is crucial to a lab's success. Laboratory professionals can use the Lockbox LIMS system to manage their samples. They have full visibility of every step of the sample's journey from accession to long-term storage. LIMS analysis is more than just tracking results. Lockbox's multilayered sample storage and location management functionality lets you define your lab's storage structure using a variety location options: rooms and storage units, shelves and racks, boxes and boxes.
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Adaptive Compliance Engine (ACE)
Adaptive Compliance Engine® (ACE®) is a highly configurable, workflow based eQMS/eDMS and more that can adapt to any business process, allowing for real-time tracking, management, and reporting of all compliance, quality, and operational activities. With ACE®, you will minimize the administrative hassles and maximize ROI with productivity gains from day one – all while 21 CFR Part 11 compliant.
Our one-stop software includes:
-Office 365 Integration
-Inspection Management
-Document Management
-Risk Management
-Product Lifecycle Management
-Learning Management
-Audit Management
-Quality Events
-Paperless Validation
-Electronic Signatures (21 CFR Part 11 Compliant)
-Endless Workflow Configurations
-And so much more!
Empower all levels of your organization with intuitive user interfaces, easily search for all your documents and records, and transform your data into actionable intelligence with advanced analytics all on a single platform.
ACE comes with everything you need, all included at one price. Every application is included, no more a la carte pricing. No more nickel and diming. One software, endless solutions.
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Kivo
Kivo offers an innovative solution for sponsors and CROs, providing an economical document and process management platform that enables life sciences teams to efficiently accomplish their tasks within a single, user-friendly, and compliant environment. By integrating DMS, RIM, QMS, eTMF, and eCTD functionalities, Kivo allows teams in pharmaceuticals, biotechnology, medical devices, and biologics to handle regulated documents, quality management activities, clinical trial documentation, regulatory submissions, and workflow processes without the hassle of using multiple disconnected tools. With Kivo’s Document Management System, users can manage controlled documents and automate processes while ensuring project oversight, corporate documentation, and readiness for due diligence in a centralized manner, featuring version control, collaboration tools, audit trails, search capabilities, workflow automation, and Part 11-compliant electronic signatures. Additionally, the RIM system enhances project management and correspondence, facilitates submission building and publishing handoff, provides eCTD viewing options, and streamlines dossier management and interactions with health authorities. Overall, Kivo equips life sciences teams with the necessary tools to maintain compliance and efficiency in their operations.
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