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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Haast is an AI-powered compliance engine that helps enterprises eliminate manual marketing reviews and move faster with confidence.
It uses AI agents to automatically detect and resolve regulatory and brand risks across content, websites, and social channels. By learning each company’s risk tolerance, Haast ensures consistent, policy-aligned decisions without slowing teams down. Marketers can check and fix content before it goes live, while legal teams gain faster, more reliable oversight without being overwhelmed by approvals. Haast works across text, images, PDFs, video, and web content, supporting both pre-launch checks and continuous monitoring of live assets. Embedded directly into existing workflows, it transforms compliance from a bottleneck into a scalable, automated system.
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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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Kollate-it
Kollate-it is an all-in-one GRC and due diligence solution with over 400 features. It helps users to integrate their due diligence, compliance, risk management and audit activities and reporting into at lightning speed. Powered by AI designed workflows, automation and ingestion engines users can integrate, customize, automate their information and can select different product modules to meet their needs. Kollate-it gets rid of user frustration. The software helps all regulated companies document their processes for review across the business. The software solves a number of problems including:
(1) data input dramatically reduces
(2) work tasks speed up
(3) Activities get tracked instantly
(4) cost savings accelerate
(5) human errors reduce
(6) Information silos collapse
(7) reporting is faster and 24/7 and
(8) document retrieval is immediate.
The software is agile, adaptable and allows a user to add their own compliance framework. The document management module helps the user to upload their documentation to match their obligations so they can stop switching between multiple applications or trying to locate documents to show how the business meets to its obligations. Customized automation can also be done.
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