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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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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MasterControl
Bringing innovative products to market in heavily regulated sectors often feels like an unending series of compromises. However, MasterControl's GxP software streamlines workflows, ensuring that you don't have to sacrifice quality for cost or innovation in the face of regulation.
With a perfect blend of completeness and connectivity, combined with a focus on flexibility and speed, MasterControl Quality Excellence turns quality data and processes into a significant competitive advantage.
The journey toward modernizing your manufacturing operations begins with advanced software solutions. MasterControl Manufacturing Excellence simplifies the digital transformation of manufacturing, covering everything from work orders and production records to logbooks and work instructions, making it the most straightforward approach to digitizing your manufacturing processes.
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meddevo
Meddevo provides a dedicated workspace for each team member, allowing them to create, manage, and automate the technical documentation related to medical devices and in vitro diagnostics (IVDs), functioning as a comprehensive SaaS solution. You can efficiently handle changes, Corrective and Preventive Actions (CAPAs), complaints, and tailored processes directly within the platform. Thanks to the seamless synchronization of the electronic Quality Management System (eQMS) and electronic Technical Documentation (eTD), you will achieve unparalleled visibility into your operations. This solution is designed to significantly decrease administrative workloads and streamline processing times, ultimately enhancing overall productivity. By leveraging these tools, teams can focus more on innovation rather than paperwork.
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