Compare CPSIA Ready vs. Substantio

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.

Sutton is a manufacturing and distribution ERP platform that combines core operations management with AI-driven automation and customizable applications. The software centralizes inventory, warehousing, sales, purchasing, production, fulfillment, traceability, and compliance in one system. Inventory capabilities include real-time stock visibility, multi-location management, demand forecasting, shipping workflows, and monitoring of materials that may run out. Production features support shop-floor control, production scheduling, work centers, materials, jobs, and operational tracking. Sutton’s intelligence layer analyzes operational data to surface business health, identify exceptions, recommend next steps, and help users act on those recommendations. AI agents can prepare purchase orders, respond to changing production requirements, generate shipping documents, and handle other repetitive operational tasks across modules. Sutton Studio allows users to create custom apps, reports, forms, and workflows by describing what they need in plain English, with the resulting tools operating directly on existing Sutton data and permissions. The platform also includes an AI-assisted onboarding process that can reformat data, map fields, make bulk edits, and configure the system for migration. Sutton integrates with ecommerce, accounting, and sales channels such as QuickBooks, Shopify, WooCommerce, Amazon, and eBay and provides flexible API access for connecting additional systems.

SciSure is a Scientific Management Platform built to support the full range of laboratory operations for scientific organizations. It combines ELN, LIMS, and Health & Safety functionality, giving teams a single system to document experiments, track sample lineage, manage chemical inventory, and run structured, audit-ready compliance processes. Instead of relying on disconnected systems, organizations get one governed platform that improves reproducibility, increases visibility into lab operations, and reduces risk as they scale.

Your Safety & Compliance Made Simple! Businesses that operate in the construction, oil & gas, mining, manufacturing, electrical, plumbing, heating, and excavating industries know all too well how important it is to comply with all mandatory documentation. It is also important to know how a company organizes everything. SiteDocs is an interactive safety management system that transforms organizations from pen-and paper archiving to a fully cloud-based, digital workspace. The system is accessible from any device running iOS or Android and features allow users to work remotely, on mobile, or offline. Employees can now sign and upload photos, add comments, and acknowledge receipt of important documentation. Administrators can also ensure that records, reports and certifications of staff are automatically updated by using the web-based panel's system parameters.

RegDesk is the most comprehensive AI-enabled RIMS platform for Medical Devices, Pharmaceuticals, and IVD companies. • Our proprietary Regulatory Intelligence for over 120+ countries is translated and accessible in a standard format. In addition, it provides alerts on evolving regulatory changes • Our AI-powered Application Builder allows RA teams to prepare and publish global applications in 1/10th of the time • Our Change Assessment capability helps RA teams understand the impact of the change(s) on an existing product(s) and the action required • Our Distributor Collaboration provides seamless workflow solutions to interact, communicate, and share documents with external business partners • Our Standards Management makes it easy for RA teams to search and manage not only international but also country-specific standards • Our Tracking & Reporting functionality allows teams to track regulatory projects across the globe, receive renewal notifications, and generate reports on KPIs within seconds For more information, visit our website.

Compliance work eats engineering time. Hyperproof exists to give that time back by automating the parts of GRC that don't need a human: pulling evidence out of GitHub, Jira, ServiceNow, Snyk, and cloud storage on a schedule, running recurring tests against high-frequency controls, and kicking off a task automatically the moment something fails instead of waiting for the next audit cycle to find out. Under the hood, Hyperproof maps one control to 160+ frameworks (SOC 2, ISO 27001, HIPAA, NIST, and others), so a control tested once can satisfy several standards instead of forcing teams to rebuild the same work per framework. AI agents handle the first pass on evidence review and gap-flagging, leaving humans to make the actual judgment calls rather than hunting down documentation. Teams using it report cutting audit prep by roughly 350 hours a year, a 66% drop in duplicate controls, and about $150K saved annually on control orchestration. It also scales to messier org charts, with the ability to scope controls by business unit or entity instead of flattening everything into one program. Built in 2018 out of the Seattle area, Hyperproof is used by engineering and security-heavy orgs like Reddit, Fortinet, Appian, and Outreach that are tired of treating compliance as a manual, spreadsheet and email process and want it to run more like the rest of their infrastructure: automated, monitored, and auditable.

Parasoft's mission is to provide automated testing solutions and expertise that empower organizations to expedite delivery of safe and reliable software. A powerful unified C and C++ test automation solution for static analysis, unit testing and structural code coverage, Parasoft C/C++test helps satisfy compliance with industry functional safety and security requirements for embedded software systems.

Your employees can connect to everything they need to do the job. iTacit is more than an employee app. It gives your front-line access to email-free messages and training, a social intranet as well as digital forms, checklists, and other resources. Better engagement starts with hiring and continues through employee retention. iTacit makes it easy to streamline recruitment, onboarding, training, as well as setting performance goals and standards. Keep an eye on your workforce's progress. Give your team the tools and training they need to succeed and watch them grow. iTacit can reduce or eliminate in-person training, track compliance, and offer independent learning paths for employees. Multiple teams working together and a large front-line workforce can pose challenges. Your business and customer success depend on a skilled workforce. This means you will already face the challenges of segmenting communications, managing compliance records, and other tasks.

Propel is a modern, AI-powered cloud platform built for how manufacturers work today. It unifies Product Lifecycle Management (PLM), Quality Management System (QMS), and Product Information Management (PIM) into one intelligent system, giving teams a connected, always-accurate view of their products. With AI embedded across the platform through Propel One, manufacturers can automate routine work, surface insights faster, and make better decisions with confidence. AI continuously learns from product data to proactively flag risks, highlight trends, and guide next best actions across teams. Instead of relying on spreadsheets, siloed tools, and manual handoffs, teams manage product data, changes, and quality processes in a single governed environment with full traceability. Propel creates a true digital product record that spans design, development, manufacturing, commercialization, and continuous improvement. Built-in workflows standardize change management, streamline quality events, and support compliance without slowing teams down. Trusted by medical device, high tech, and industrial manufacturers, Propel helps organizations reduce errors, shorten cycle times, and improve collaboration across engineering, quality, operations, supply chain, and product teams. The result is faster launches, higher product quality, and a more resilient foundation for growth as products and processes become more complex. 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. Designed to scale with growing products, teams, and regulatory demands.

SDS Manager is a premier provider of SDS Management solutions, featuring one of the world’s largest SDS databases with over 14 million Safety Data Sheets in 25 languages. With SDS Manager, employees can access essential SDS information directly from their mobile devices by simply scanning QR code posters in work areas where chemicals are used. This seamless mobile access promotes both safety and regulatory compliance. Our automated data extraction feature lets you effortlessly add SDS files to your library without any manual typing, significantly improving accuracy and streamlining SDS management. Keep your SDS library updated, organized, and ready for quick access in a secure cloud environment.