CPSIA Ready vs. PATINA Comparison Chart

Qualio is the leading quality and compliance platform built exclusively for emerging life sciences companies. MedTech, pharma, biotech, and diagnostics teams use Qualio to standardize quality processes, connect them to regulatory obligations, and gain real-time visibility into compliance health. With a modern eQMS at the core and Compliance Intelligence layered on top, Qualio helps teams get audit ready in weeks and stay audit ready forever — without spreadsheets, fire drills, or heavyweight GRC systems. What Qualio delivers: ✔️ Audit ready in weeks ✔️ Inspection ready anytime — no fire drills ✔️ Faster market entry ✔️ Lower total cost of compliance ✔️ Confident, risk-managed scaling

Sutton (formerly Digit Software) is an AI-native operating system built for companies that manage physical operations, from manufacturing and inventory to distribution and beyond. It gives you a powerful, all-in-one core that runs your operations out of the box, with the flexibility to extend, shape, and mold it to fit exactly how your business works. With Sutton Studio, teams can build and launch their own custom apps directly on the platform using natural language, no code required, with permissions inherited from the tools they already use. The result is a system that adapts to your business in minutes, not months. The platform includes capabilities for supplier management, serialized and lot-based inventory tracking, bills of materials and routings, production scheduling, quality control, guided picking and packing, and order fulfillment. It features a built-in B2B portal for customer and distributor collaboration, job scheduling for production and service teams, and integrations with accounting and commerce tools such as QuickBooks and Shopify and so much more. By connecting systems that were once siloed, and letting teams extend the platform themselves instead of waiting on a vendor roadmap, Sutton becomes the real-time, AI-native operating system for product-based businesses, giving companies visibility, accuracy, and confidence across every process.

SciSure helps scientific organizations replace fragmented, disconnected systems with a single governed platform for managing lab operations, so teams spend less time reconciling data across tools and more time on research. By combining Electronic Lab Notebook (ELN), Laboratory Information Management System (LIMS), and Health & Safety (EHS) capabilities in one system, SciSure improves reproducibility, strengthens visibility into day-to-day lab activity, and helps organizations reduce risk as they scale. Researchers document experiments, protocols, and results in a structured, searchable digital format with customizable templates and version control, replacing paper notebooks and scattered files. Samples are tracked from intake through processing, storage, and disposal, maintaining full lineage and chain-of-custody records alongside chemical and general lab inventory management and workflow automation. Health & Safety functionality is built into the same platform, covering chemical inventory alongside Safety Data Sheets (SDS), regulatory compliance workflows, and audit readiness, so labs don't need a separate system to stay compliant and audit-ready. Labs can also extend the platform through an optional marketplace of add-ons, so they can bring in additional capability, like AI-powered support, automated data analysis, protocol generation, toxicity prediction, and image analysis, only where it adds value, without disrupting the rest of their workflow or committing to features they don't need. SciSure also connects directly to lab instruments, external databases, and third-party tools, so data moves between systems without manual re-entry. SciSure supports both cloud and dedicated hosting, giving organizations control over the deployment model that fits their infrastructure, security, and compliance requirements. It's built to serve academic institutions, biopharma and biotech companies, and start-ups alike, with role-based support for scientists, lab operations staff, safety and compliance teams, leadership, and IT professionals, so the platform works the way each type of user actually needs it to.

Your Safety & Compliance Made Easy! A business that operates in industries involving Construction, Oil & Gas, Mining, Manufacturing, Mechanical, Electrical, Plumbing, Heating, and Excavating know first hand the importance of staying in compliance with mandatory documentation. In addition, how a company manages to keep everything organized is equally important. SiteDocs is a highly interactive advance Safety Management System that takes organizations from pen-and-paper archiving to a complete, cloud-based, digital workspace. Built with features that allow users to work remotely, mobile, and even offline, the system can virtually be accessed across multiple devices that run on iOS or Android. Employees can now easily complete & sign forms, upload photos with comments and acknowledge receipt of important documentation. All while admin users ensure that staff records, reports, and certifications are automatically updated using system parameters within the web-based panel.

RegDesk is a Regulatory Information Management System (RIMS) that helps medical device companies manage global regulatory submissions, product registrations, and compliance in one centralized platform. It streamlines regulatory workflows, organizes regulatory data, and provides global regulatory intelligence to help teams navigate complex requirements across multiple markets. Regulatory affairs and quality teams benefit by reducing manual work, improving submission accuracy, and accelerating time to market. Our capabilities are as follows: • AI Application Builder • Regulatory Intelligence • Change Assessment • Standards Management • Country-Specific Templates • Distributor Collaboration • AI Document Management • Tracking & Reporting • Alerts and Notification • Product Management • Claims Management • EUDAMED For more information, visit our website.

Hyperproof is a governance, risk, and compliance platform built for organizations that juggle multiple regulatory frameworks. Rather than treating each standard as a separate project, Hyperproof maps a single set of controls across 160+ frameworks, including SOC 2, ISO 27001, HIPAA, and NIST, so evidence gathered once can satisfy multiple audits without duplicate work. Purpose-built AI agents surface relevant evidence, validate controls, and flag compliance gaps automatically, cutting down the manual review that typically eats up a compliance team's week. The platform connects directly to the tools IT and security teams already use — including GitHub, Jira, ServiceNow, Snyk, CrowdStrike, MongoDB Atlas, Google Workspace, and Microsoft SharePoint — and pulls evidence into Hyperproof, eliminating the need for teams to chase it down manually. High-frequency controls can be tested on a recurring schedule, with failures automatically generating tasks and escalations so nothing slips through the cracks between audit cycles. A built-in risk register lets risk owners across departments document risk treatment plans and tie them directly to the controls that address them. Hyperproof also supports organizations with complex structures, letting larger companies scope controls to specific business units, subsidiaries, or entities rather than forcing everything into one flat compliance program. Customers report meaningful results from this approach: a 70% increase in compliance productivity, roughly $150,000 in annual savings on control orchestration, a 66% cut in duplicative controls, and about 350 fewer hours spent on audit preparation each year. Founded in 2018 and based in the Seattle area, Hyperproof works with organizations like Reddit, Fortinet, Appian, Outreach, and Thales as they move from reactive, spreadsheet-driven compliance to a continuous, audit-ready operating model. Best fit: IT, security, and compliance teams at growing technology companies that manage multiple frameworks simultaneously and want to reduce the manual overhead of audit prep.

"Parasoft delivers an AI‑powered software testing platform that helps organizations continuously release high‑quality software. Our solutions support embedded and enterprise teams by integrating code analysis, testing, virtualization, and coverage into the delivery pipeline to improve security, reliability, and compliance while reducing cost and effort. Parasoft C/C++test provides static analysis, unit testing, code coverage, and requirements traceability for C and C++ applications. It integrates with Eclipse and Visual Studio, supports CI/CD automation, and is TÜV‑certified for safety‑ and security‑critical systems. Parasoft C/C++test CT is a scalable, compliance‑ready solution for C and C++ teams. It integrates into CI/CD workflows, supports open‑source unit testing frameworks, containers, VS Code, Bazel build systems, eliminates IDE dependencies, and is TÜV‑certified for safety‑ and security‑critical development."

iTacit is a frontline workforce platform that connects training, compliance, communication, and day-to-day processes in one mobile-first system. Give frontline employees easy access to the training, policies, procedures, forms, checklists, and information they need to do their jobs, wherever the work happens. Leaders gain greater visibility into completion, certifications, compliance records, and work happening across teams, locations, and shifts. With iTacit, organizations can digitize onboarding and frontline training, manage recurring and role-based learning, track certifications and training requirements, deliver mobile SOPs and policies, and replace paper forms and checklists with connected digital workflows. iTacit also helps teams manage safety and compliance processes including inspections, incident reporting and follow-up, corrective actions, audits, JSA/JHA workflows, and other field processes. Training, documentation, assigned actions, and records stay connected, making it easier to see what has been completed, what needs attention, and whether required follow-up has happened. For organizations managing large, distributed, or deskless workforces, iTacit brings the tools employees use and the visibility leaders need into one platform. Reduce disconnected systems and manual tracking, strengthen compliance, simplify frontline training, and give employees a better way to access information and complete required work from the field.

Propel is a cloud-native platform that unifies PLM, QMS, and PIM in one connected system, giving manufacturers complete visibility and control across the entire product lifecycle. It provides a single source of truth for product data, streamlines change management, strengthens quality and compliance, and accelerates time-to-market by eliminating silos. With real-world AI use cases and enterprise-grade security, Propel helps organizations reduce errors and improve cross-functional alignment. Agentic AI accelerates change reviews, surfaces BOM and quality risks, enriches product information, and guides decisions—while role-based permissions and audit trails protect IP. From design through manufacturing and commercialization, Propel empowers companies to deliver innovative, high-quality products faster with greater confidence. Each module deploys independently with no required dependencies.

SDS Manager is a leading provider of Safety Data Sheet (SDS) management systems, offering one of the largest SDS databases with over 14 million documents available in 25 languages. With SDS Manager, employees can easily access Safety Data Sheets directly from their mobile devices by scanning QR code posters placed in work areas where chemicals are used, enhancing safety and compliance in the workplace. Our automated data extraction feature allows you to add SDS files to your library with zero typing required, streamlining the process and ensuring accuracy. The one-click Secondary Container Labeling provides an efficient solution for enhancing safety and regulatory compliance Receive alerts on restricted substances in the chemicals you utilize, including those listed under REACH - ECHA, California Proposition 65, ZDHC, and more. The Chemical Risk Assessment function is designed to evaluate and manage the risks associated with handling and storing chemicals.