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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Process Street
Process Street is the Compliance Operations Platform built for teams that need to move fast without breaking standards. It combines document control, workflow automation, and AI-powered oversight in a single system so every policy is followed, every step is tracked, and every audit is effortless.
Unlike legacy GRC tools or static SOP docs, Process Street turns compliance into a living system. Policies are documented in governed, version-controlled Pages. Those policies are executed through dynamic workflows with built-in task assignment, approvals, and forms. Every action is logged, monitored, and optimized in real time by Cora, our AI compliance agent.
Used across industries like financial services, real estate, healthcare, and manufacturing, Process Street helps teams automate employee onboarding, streamline audits, manage policy updates, enforce vendor reviews, and run critical processes at scale.
No code required. No micromanagement. Just proof that work gets done right, every time.
Companies like Salesforce, Colliers, Drift, and Hartford Healthcare trust Process Street to eliminate busywork, improve operational visibility, and reduce compliance risk across the business. With native integrations, role-based access, audit trails, and ISO-aligned workflows, it is the platform that makes compliance a competitive advantage.
From onboarding to audits, Process Street is how high-stakes teams enforce standards, automate execution, and prove compliance by default.
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Labguru
Labguru, a cloud-based Electronic Lab Notebook, LIMS and Informatics Platform that offers a complete solution to life science research and industry, is secure and reliable. It records and manages laboratory data, inventory, molecular biology tools, and chemistry tools. This allows labs to run more efficiently and automates lab operations.
Labguru allows scientists to design experiments and workflows. They can also capture structured and unstructured information, manage projects, and share their results. You can create custom-designed experiment templates and integrate protocols, SOPs and other cutting-edge features to improve data quality, streamline workflows, and reduce costs. Labguru is available via the cloud on desktops as well as mobile devices.
Labguru is part Holtzbrinck Publishing Group. It serves more than 100,000 scientists from universities, research institutes, startups, and large pharma companies around the world.
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MediaLab Document Control
Document Control is MediaLab’s document management system. Our online solution empowers lab directors and supervisors to manage their policies, procedures, forms, job aids, and worksheets using configurable review settings, custom approval workflows, automated employee sign-offs, and more! Reduce time spent chasing approval and review signatures while benefiting from email notifications and personalized to-do lists for employees.
MediaLab's Document Control supports:
• Digital records and version control of all documents,
• Standardization across all documents from all sites,
• Electronic signatures that meet 21 CFR Part 11 standards,
• Customized approval workflows and processes,
• Robust searching to easily locate specific documents, and more!
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