RegDesk
RegDesk stands out as the leading RIMS platform enhanced by AI, tailored specifically for Medical Device, Pharmaceutical, and IVD companies.
• Our unique Regulatory Intelligence encompasses data from over 120 countries, all presented in a uniform format, and includes timely alerts regarding regulatory updates.
• With our AI-driven Application Builder, regulatory affairs teams can efficiently create and submit global applications in a fraction of the usual time.
• The Change Assessment feature enables RA teams to evaluate the implications of changes on current products and determine the necessary actions.
• Our Distributor Collaboration tool facilitates smooth workflows for communication and document sharing with external partners.
• The Standards Management function simplifies the process for RA teams to locate and oversee both international and country-specific standards.
• Additionally, our Tracking & Reporting capability empowers teams to monitor regulatory initiatives worldwide, receive notifications for renewals, and quickly compile reports on key performance indicators.
To learn more about our offerings, please explore our website.
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Adaptive Compliance Engine (ACE)
The Adaptive Compliance Engine® (ACE®) is a versatile, workflow-driven eQMS/eDMS solution that can seamlessly adjust to various business processes, providing real-time oversight, management, and reporting for compliance, quality, and operational tasks. By utilizing ACE®, organizations can alleviate administrative burdens and enhance ROI through immediate productivity improvements, while maintaining adherence to 21 CFR Part 11 regulations.
Our comprehensive software suite features:
-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 numerous additional capabilities!
Enable every tier of your organization with user-friendly interfaces, effortlessly locate all documents and records, and convert your data into insightful intelligence through advanced analytics, all within one unified platform.
Every essential application is bundled together at a single price with ACE, eliminating the need for separate purchases. Enjoy the convenience of one software solution with countless functionalities, making it a truly invaluable asset for your business.
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Qualio
Qualio serves as a comprehensive platform for managing quality and compliance needs, making it particularly suitable for expanding businesses in the healthcare and life sciences sectors. Not only is Qualio dependable and cost-effective, but it also boasts a user-friendly interface. This innovative tool enables companies to accelerate the development of life-saving products while ensuring full compliance with ISO, GxP, and FDA standards. By centralizing functions such as document control, training, non-conformance reports (NCRs), audits, supplier management, and handling complaints, Qualio simplifies the operational processes for its users. This integrated approach allows organizations to focus on their core mission of improving health outcomes.
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SAP Business ByDesign
SAP Business ByDesign is a cost-effective and user-friendly enterprise resource planning (ERP) solution tailored for rapidly expanding small to mid-sized businesses as well as divisions of larger enterprises.
This platform encompasses essential functions such as financial management, inventory control, customer relationship management, and human resources, providing comprehensive integration for enhanced visibility, operational efficiency, and better management oversight. By acting as a central hub for all business data, SAP Business ByDesign facilitates real-time access to information, enabling swift and informed decision-making that can adapt to changing circumstances.
Designed with built-in workflows and industry best practices, SAP Business ByDesign ensures that your operations are optimized from the very start and can seamlessly expand alongside your organization, eliminating the need for a system overhaul during growth phases.
Key attributes of SAP Business ByDesign include:
A unified architecture that consolidates all company information, ensuring smooth data flow, and delivering complete visibility and governance over operations. It also offers automation of business processes from end to end, real-time analytics and reporting capabilities for accurate insights, as well as the flexibility to customize features to meet specific industry and business needs, all while providing secure access to data from any location at any time. Additionally, this system positions itself as a comprehensive solution that evolves with your business, ensuring that as your needs change, your ERP system remains a valuable asset.
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