Compare CPSIA Ready vs. MakerComply

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.

Compliance training is different from other forms of workplace learning because success isn't measured by completion rates, but by the behaviours, decisions, and outcomes it influences. Yet many organisations continue to depend on generic training or poorly governed AI-generated content, leaving themselves exposed to compliance failures, regulatory scrutiny, and reputational risk. For over 25 years, Skillcast has helped organisations move beyond tick-box compliance. By combining compliance expertise, AI-enabled technology, and expert human oversight, we help you: - Manage compliance learning, policies, disclosures, and registers from a single platform. - Deliver personalised learning experiences that improve engagement and reduce training fatigue. - Strengthen governance with policy management, disclosures, registers, and audit-ready reporting. - Track CPD, learning activity, and compliance outcomes with complete visibility. - Provide employees with instant AI-powered guidance based on trusted organisational content. - Adapt and customise expert compliance content quickly with AI-assisted authoring. - Choose from ready-to-deploy, configurable, or fully bespoke solutions. The result is stronger compliance cultures, smarter compliance decisions, and greater confidence that your training is reducing risk, not simply recording completion. Trusted by 1,400+ organisations worldwide, Skillcast is the specialist compliance partner helping businesses turn compliance training into a front-line defence.

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.

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.

Iru AI reimagines enterprise security and IT management with a unified, AI-driven platform that eliminates tool fragmentation and operational overhead. At its core is the Iru Context Model, a dynamic intelligence layer that connects identity, endpoint, and compliance management into one cohesive ecosystem. The platform offers passwordless authentication, device-bound access policies, and real-time vulnerability detection—creating a trust fabric that safeguards every user and device. Iru’s endpoint suite integrates management, detection, and response capabilities across Apple, Windows, and Android environments for holistic protection. Its Compliance Automation engine continuously maps and updates controls, ensuring organizations remain audit-ready while accelerating deal cycles. By merging automation with contextual intelligence, Iru empowers IT and security teams to make faster, smarter decisions. Companies gain a consolidated view of their infrastructure, reducing zero-day exploit risks and boosting productivity across teams. With a 4.75/5 G2 rating and adoption by thousands of high-growth enterprises, Iru delivers a future-ready foundation for secure, intelligent business operations.

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.

HSI Donesafe redefines EHS management with a no-code, cloud-based platform that transforms complex processes into streamlined, user-friendly workflows. Trusted across industries, Donesafe consolidates tracking, management, and reporting into one accessible platform, making compliance simpler and safety more effective. Donesafe’s adaptable design allows teams to customize workflows, forms, and dashboards to meet evolving compliance needs. With tools for incident reporting, audits, training, and risk assessment, staying ahead of regulatory changes has never been easier. Key Features: - Customizable workflows to align with regulations - Real-time insights for live safety tracking - Scalable design that grows with your team - Streamlined compliance tools for smooth audits and reporting Empower your EHS team to achieve safety excellence with HSI Donesafe.

Certainty is an enterprise-level auditing and inspection software that can be trusted to help you manage and report on business risk, compliance, and performance metrics quickly and efficiently. Certainty Software is used by hundreds of thousands of professionals to complete millions of inspections and audits each year. It provides all the tools you need to collect, collate, and report consistent, accurate, and meaningful metrics across your business. Certainty provides all the tools you need to design, manage, and report on audit/inspection data, as well as help you manage and mitigate any risks, incidents, and issues that may be identified during the audit/inspection process.