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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Emtrain
Our online training (via our LXP or xAPI to your LMS) provides online training employees actually appreciate plus skills assessments and risk benchmarking.
Compliance courses for Preventing Workplace Harassment, Cybersecurity, Global Data Privacy, AI Governance, and more. Content is written by lawyers with decades of expertise preventing workplace harassment & motivating business compliance. Our flagship anti-harassment courses meet all relevant laws (CA, NY, IL, UK, AUS, CAN, IND, MEX, etc.) Emtrain courses include binge-worthy workplace video, interactive scenarios, skill building techniques, reflection questions, completion certificates, and litigation-ready reports.
100+ microlessons for continued learning OR to remediate disrespectful or non-compliant behaviors.
Clients include Cisco, Degreed, Genentech, Glassdoor, Google, Instacart, NPR, Whirlpool.
Partners: Workday Cloud Connect; Udemy Business; Ninjio
Don't just check the compliance box. Your co-workers deserve more!
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Cybrance
Safeguard your organization with Cybrance's comprehensive Risk Management platform, which allows for efficient oversight of your cybersecurity and regulatory compliance initiatives while effectively managing risk and monitoring controls. Engage with stakeholders in real-time to complete tasks swiftly and effectively, ensuring that your company remains protected.
With Cybrance, you have the ability to easily design tailored risk assessments that align with international standards like NIST CSF, 800-171, ISO 27001/2, HIPAA, CIS v.8, CMMC, CAN-CIOSC 104, ISAME Cyber Essentials, and others.
Eliminate the hassle of outdated spreadsheets; Cybrance offers collaborative surveys, secure evidence storage, and streamlined policy management to simplify your processes. Stay ahead of your assessment obligations and create organized Plans of Action and Milestones to monitor your advancements. Protect your organization from cyber threats and compliance failures—opt for Cybrance to achieve simple, efficient, and secure Risk Management solutions that truly work for you. Let Cybrance empower your risk management strategy today.
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QT9 QMS
Unify quality processes with QT9's all-in-one cloud-based QMS Software Suite. QT9 QMS is a user-friendly quality management software that includes 25+ modules with unlimited scalability. Automate ISO & FDA Compliance with email alerts, To Do lists and FDA 21 CFR Part 11 Compliant Electronic Approvals.
QT9 QMS enables Life Sciences, Biotechnology Companies, Medical Device Manufacturers and Pharmaceutical Companies to digitally transform operations.
Get real-time status updates and visualize quality metrics up-to-the-minute. QT9 QMS comes with built-in document control, revision-level controls, corrective actions (CAPAs), Nonconforming products and more. Advance product releases with Deviation Management, Engineering Change Orders, FMEA, Inspection Management Modules Included.
Go paperless & put time-consuming tasks on autopilot. QT9 QMS comes ready-to-use. Get a free product tour! Start a Free Trial. Visit QT9qms.com
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