CPSIA Ready vs. Assent

Qualio is a unified quality and compliance platform that helps growing life sciences companies scale faster while staying continuously audit- and inspection-ready. Medical device, digital health, biotech, and pharma teams use Qualio to replace manual processes and disconnected tools with a single source of truth for quality, regulatory readiness, and risk. With a modern eQMS at the foundation and Compliance Intelligence layered on top, Qualio moves teams beyond point-in-time audits. Automated gap analysis, cross-standard evidence mapping, and real-time readiness dashboards provide confidence that the organization is prepared today—not just when auditors arrive. Qualio centralizes document control, training, CAPA, change management, supplier quality, and design controls, linking them directly to regulatory requirements and product lifecycle data. Executive-ready views show compliance health by standard, region, and product, turning regulatory readiness into a measurable business capability instead of a black box. Compliance Intelligence continuously monitors for risk, highlights gaps early, and prioritizes remediation so teams focus effort where it matters most. Pre-validated regulatory frameworks are maintained as requirements evolve, reducing reliance on consultants and avoiding duplicate work as companies expand. The result is faster market entry, lower compliance cost, reduced risk of findings or recalls, and confident, risk-managed growth.

Sutton is an AI-powered ERP and operations platform designed for manufacturers, distributors, wholesalers, and other companies that manage physical inventory and production processes. Formerly known as Digit, the platform combines inventory, production, sales, purchasing, fulfillment, traceability, and compliance in a connected system. Inventory management tools provide real-time stock tracking, multi-site visibility, warehouse controls, demand forecasting, and fulfillment support. Production capabilities cover shop-floor control, scheduling, work centers, materials, jobs, and other manufacturing workflows needed to keep operations on schedule. Sales and purchasing modules connect customer demand with procurement and production activity, helping teams manage orders, suppliers, and replenishment from one environment. Sutton’s intelligence layer monitors business performance and operational health, answers questions about current conditions, and can recommend actions based on inventory levels, open orders, demand, supplier lead times, and other live data. Its AI agents can go beyond recommendations by preparing purchase orders, adjusting operational workflows, generating shipping documents, and handling repetitive tasks across the ERP. Sutton Studio gives users a way to create custom applications, reports, forms, and processes through plain-English instructions instead of waiting for vendor development or outside consulting. Apps created in Studio work directly with Sutton’s existing operational data and automatically inherit the same user roles and record-level permissions. Sutton also includes an AI-assisted onboarding agent that can analyze spreadsheets, map columns, reformat data, make bulk changes, and help configure the system before users review and confirm the results. Integrations with tools such as QuickBooks, Shopify, WooCommerce, Amazon, and eBay, together with API and MCP connectivity.

SciSure is a platform for managing laboratory operations end-to-end, built for scientific organizations. It brings together ELN, LIMS, and Health & Safety tools so teams can document experiments, track samples, manage chemical inventory, and maintain compliance workflows that are structured and audit-ready. By replacing fragmented systems with a single governed platform, SciSure helps organizations improve reproducibility, gain clearer operational visibility, and scale lab operations with less risk.

Making Safety and Compliance Effortless! Companies engaged in construction, oil and gas, mining, manufacturing, electrical work, plumbing, heating, and excavation clearly recognize the significance of adhering to essential documentation requirements. Additionally, it's crucial for these businesses to efficiently manage their organizational structures. SiteDocs offers an innovative safety management platform that shifts enterprises from traditional paper-based systems to a comprehensive cloud-driven digital environment. This versatile system is compatible with any device that operates on iOS or Android, empowering users to work from anywhere, whether remotely, on-the-go, or even offline. Employees can seamlessly sign documents, upload images, provide feedback, and confirm the receipt of vital paperwork. Furthermore, administrators benefit from the web-based panel, which ensures that all staff records, reports, and certifications are kept up-to-date automatically by utilizing the system's configurable parameters. This modernization not only streamlines processes but also enhances overall workplace safety and compliance.

Hyperproof is a compliance operations platform designed to help organizations replace reactive, manual audit prep with a continuous, well-managed program. Instead of running each regulatory framework as its own project, Hyperproof lets teams map a single control across 160-plus frameworks, so the evidence and testing already completed for one standard can count toward another, removing duplicate effort as new regulations come into scope. For business and compliance leaders, the value shows up in measurable operational gains. Customers point to a 70% lift in overall compliance productivity, close to $150K trimmed from yearly control-orchestration costs, and a 66% drop in the duplicative control work that piles up when frameworks aren't mapped together. On average, audit prep shrinks by roughly 350 hours annually. The platform's risk register provides risk owners across the business with a shared place to document risks and treatment plans, giving leadership better visibility into where the organization stands at any given time, rather than having to reconstruct that picture ahead of every audit. Hyperproof is built to flex with organizational complexity, supporting companies with multiple business units or subsidiaries that need to scope compliance programs differently across entities rather than manage a single flat structure. Combined with integrations into commonly used business and IT systems, teams can keep compliance work embedded in their existing processes rather than managing it as a parallel, disconnected effort. Headquartered near Seattle and founded in 2018, Hyperproof is the compliance platform of choice for organizations such as Reddit, Fortinet, Appian, Outreach, and Thales as they professionalize compliance operations and reduce the resourcing burden of staying audit-ready. Best fit: compliance, risk, and operations leaders at mid-market and enterprise organizations managing regulatory complexity across multiple frameworks or business units.

Parasoft aims to deliver automated testing tools and knowledge that enable companies to accelerate the launch of secure and dependable software. Parasoft C/C++test serves as a comprehensive test automation platform for C and C++, offering capabilities for static analysis, unit testing, and structural code coverage, thereby assisting organizations in meeting stringent industry standards for functional safety and security in embedded software applications. This robust solution not only enhances code quality but also streamlines the development process, ensuring that software is both effective and compliant with necessary regulations.

Propel is a modern, AI-powered product management platform built for today’s manufacturers. It brings Product Lifecycle Management (PLM), Quality Management System (QMS), Product Information Management (PIM), and robust supplier management together in one cloud-based solution, giving teams a single, always-accurate view of their products across the entire lifecycle. With AI embedded directly into the platform through Propel One, teams can automate routine tasks, surface insights faster, and make more confident decisions using real product and quality data. AI helps reduce manual effort, identify risks earlier, and keep work moving across change management, quality events, and product operations. Propel replaces spreadsheets and disconnected systems with a governed digital product record that spans engineering, quality, operations, supply chain, and product teams. Built-in workflows standardize change control, streamline quality processes, and support compliance without slowing teams down. Every update and approval is tracked with full traceability, helping manufacturers reduce errors, shorten cycle times, and improve cross-functional collaboration. Trusted by medical device, high tech, and industrial manufacturers, Propel is designed for complex products and regulated environments. The platform scales easily as products, teams, and requirements grow, providing a strong foundation for long-term innovation. Propel delivers enterprise-grade security and reliability through its architecture on the Salesforce platform, including robust data protection and access controls. Customers do not need to be Salesforce users to benefit from Propel’s security and capabilities. Propel has been recognized by Deloitte as a fast-growing technology company and named to the Inc. 5000 list of fastest-growing private companies, reflecting strong customer adoption and momentum helping manufacturers modernize how they build, manage, and deliver products.

Your workforce is equipped with all the resources necessary to perform their tasks efficiently. iTacit transcends the typical employee application, providing frontline staff with seamless access to communication without the need for email, as well as a social intranet, digital forms, checklists, and various other essential tools. Enhancing engagement begins at the hiring stage and continues through effective employee retention strategies. With iTacit, you can simplify the processes of recruitment, onboarding, training, and establishing performance benchmarks. Monitor your team's growth effectively while furnishing them with the necessary tools and training for success. The platform not only minimizes the need for face-to-face training but also ensures compliance and offers personalized learning tracks for each employee. Collaborating across multiple teams, especially with a large frontline workforce, can be challenging, yet your organization’s success, along with customer satisfaction, hinges on maintaining a proficient workforce. This reality means you will inevitably encounter obstacles related to the segmentation of communications, the management of compliance documentation, and other administrative responsibilities that arise in a dynamic work environment. Ultimately, iTacit empowers your business to face these challenges head-on, fostering a culture of continuous improvement and adaptability.

SDS Manager stands out as a leading provider of Safety Data Sheet (SDS) Management solutions, boasting one of the most extensive SDS databases globally, which contains over 14 million Safety Data Sheets available in 25 different languages. With SDS Manager, employees can conveniently retrieve crucial SDS information directly on their mobile devices by scanning QR code posters placed in areas where chemicals are handled, thereby enhancing both safety measures and adherence to regulatory standards. This intuitive mobile access not only facilitates immediate information retrieval but also fosters a culture of safety within the workplace. Additionally, our automated data extraction capabilities allow for the effortless integration of SDS files into your library without the need for manual data entry, which greatly enhances accuracy and optimizes the process of SDS management. Your SDS library remains consistently updated, well-organized, and readily accessible, all within a secure cloud environment, ensuring that you are always prepared for audits or emergencies.

Certainty is a comprehensive software solution for auditing and inspection that offers reliable support in managing and reporting on business risks, compliance, and performance indicators swiftly and effectively. Utilized by countless professionals, Certainty Software facilitates millions of inspections and audits annually, equipping users with essential tools to gather, organize, and present precise, consistent, and actionable metrics throughout the organization. In addition to its data management capabilities, Certainty empowers users to design, oversee, and report on inspection and audit findings while also assisting in the identification and mitigation of risks, incidents, and challenges that may arise during the auditing process. This software not only enhances operational efficiency but also ensures that businesses maintain high standards of accountability and performance.