Qualio
Qualio is a purpose-built quality and compliance platform for life sciences companies operating in complex, high-stakes regulatory environments. Medical device, SaMD, biotech, and pharma teams use Qualio to replace fragmented eQMS tools, spreadsheets, and consultant-driven audits with a single, validated system that delivers continuous audit and inspection readiness.
Qualio combines a modern eQMS with Compliance Intelligence—an AI-driven layer that continuously evaluates how well real operating data aligns with regulatory requirements. Instead of treating audits as one-off events, teams gain always-on visibility into compliance coverage, risk exposure, and readiness across FDA, ISO, EU MDR, GxP, and software-intensive standards.
Core quality workflows—document control, training, CAPA, change management, supplier quality, and design controls—are directly connected to regulatory obligations and objective evidence. Deep integrations with Jira, Azure DevOps, GitHub, TestRail, and Salesforce automatically capture proof from development and operational systems, eliminating manual evidence gathering and reducing compliance drag on engineering teams.
Compliance Intelligence runs multi-standard gap analysis in under an hour, flags emerging risks before they become findings or 483s, and maps reusable evidence across frameworks to accelerate submissions and market expansion. All insights are explainable and traceable back to specific clauses and internal policies, supporting validation and audit expectations.
The result: audit readiness in weeks instead of months, fewer fire drills, faster launches, and lower long-term compliance cost. Qualio turns compliance from a reactive burden into a predictable, scalable system.
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Ditto
Ditto is the only mobile database with built-in edge device connectivity and resiliency, enabling apps to synchronize without relying on a central server or constant cloud connectivity. With billions of edge devices and deskless workers driving operations and revenue, businesses are hitting the limits of what traditional cloud architectures can offer. Trusted by Chick-fil-A, Delta, Lufthansa, Japan Airlines, and more, Ditto is pioneering the edge-native revolution, transforming how businesses connect, sync, and operate at the edge. By eliminating hardware dependencies, Ditto’s software-driven networking is enabling businesses to build faster, more resilient systems that thrive at the edge – no Wi-Fi, servers, or cloud required.
Through the use of CRDTs and P2P mesh replication, Ditto's technology enables you to build collaborative, resilient applications where data is always available and up-to-date for every user, and can even be synced in completely offline situations. This allows you to keep mission-critical systems online when it matters most.
Ditto uses an edge-native architecture. Edge-native solutions are built specifically to thrive on mobile and edge devices, without relying solely on cloud-based services. Devices running Ditto apps can discover and communicate with each other directly, forming an ad-hoc mesh network rather than routing everything through a cloud server. The platform automatically handles the complexity of discovery and connectivity using both online and offline channels – Bluetooth, peer-to-peer Wi-Fi, local LAN, WiFi, Cellular – to find nearby devices and sync data changes in real-time.
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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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C2P
Compliance & Risks works closely with some of the most prominent brands in the world, including Dyson, Stryker, Kodak, Lenovo and Samsung. We simplify the ESG and Product Compliance process to unlock market access.
Three key elements are part of our offering:
1. Enterprise technology solution to improve productivity and efficiency with C2P
2. The market's most comprehensive regulatory content, with 40+ topics covering over 20+ industries and 195 nations worldwide
3. A team of subject matter experts are available to answer any regulatory questions you may have
We help you to monitor and assess the relevant regulations and standards that apply to your products and business. We also help you prove ESG and product compliance in order for your business to remain on the market and grow.
We have over 20 years experience working with some of the most iconic brands in the world and have a remarkable track record of helping companies to manage compliance risks more effectively than ever.
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