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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Predict360
Predict360, by 360factors, is a risk and compliance management and intelligence platform that automates workflows and enhances reporting for banks, credit unions, financial services organizations, and insurance companies.
The SaaS platform integrates regulations and obligations, compliance management, risks, controls, KRIs, audits and assessments, policies and procedures, and training in a single cloud-based SaaS platform and delivers robust analytics and insights that empower customers to predict risks and streamline compliance.
Happy with your current GRC but lacking a true analytics and BI tool for intuitive executive and Board reports? Ask about Lumify360 from 360factors - a predictive analytics platform that can work alongside any GRC. Keep your process management workflows intact while providing stakeholders with the timely reports and dashboards they need.
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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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Product Comply
Product Comply provides extensive 360-degree oversight of changing regulations and standards that affect your products, whether they belong to the categories of medical devices, electronics, furniture, cosmetics, or others. Our software is tailored to meet the specific compliance requirements of any regulatory environment. It adeptly manages all worldwide regulations pertaining to crucial areas like health, safety, and environmental concerns. Each regulation is systematically aligned with your product portfolio, considering components, materials, and chemicals, ensuring you remain proactive regarding any shifts in the regulatory landscape that could influence your operations. As global EHS (Environment, Health & Safety) regulations and compliance frameworks continually evolve, leveraging sophisticated software that tracks these changes is essential for minimizing monitoring workloads, thus allowing your team to concentrate on strategic initiatives that safeguard your business. This not only enhances compliance but also fosters innovation and growth by freeing up resources for more critical business strategies.
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