List of the Top 12 Product Compliance Software in 2025

The Adaptive Compliance Engine® (ACE®) is a versatile, workflow-driven eQMS/eDMS solution that can seamlessly adjust to various business processes, providing real-time oversight, management, and reporting for compliance, quality, and operational tasks. By utilizing ACE®, organizations can alleviate administrative burdens and enhance ROI through immediate productivity improvements, while maintaining adherence to 21 CFR Part 11 regulations. Our comprehensive software suite features: -Office 365 Integration -Inspection Management -Document Management -Risk Management -Product Lifecycle Management -Learning Management -Audit Management -Quality Events -Paperless Validation -Electronic Signatures (21 CFR Part 11 Compliant) -Endless Workflow Configurations -And numerous additional capabilities! Enable every tier of your organization with user-friendly interfaces, effortlessly locate all documents and records, and convert your data into insightful intelligence through advanced analytics, all within one unified platform. Every essential application is bundled together at a single price with ACE, eliminating the need for separate purchases. Enjoy the convenience of one software solution with countless functionalities, making it a truly invaluable asset for your business.

Streamline your quality processes with QT9's comprehensive cloud-based Quality Management System (QMS) Software Suite. Designed for ease of use, QT9 QMS features over 25 modules that offer unlimited scalability to meet your needs. Enhance your ISO and FDA compliance efforts with automated email alerts, task lists, and FDA 21 CFR Part 11 compliant electronic approvals. QT9 QMS empowers organizations in the Life Sciences, Biotechnology, Medical Device Manufacturing, and Pharmaceutical sectors to achieve digital transformation in their operations. Stay informed with real-time status updates and instantly visualize your quality metrics. The software includes essential features such as document control, revision management, corrective actions (CAPAs), and nonconformance tracking, among others. Additionally, it facilitates streamlined product releases with modules for Deviation Management, Engineering Change Orders, Failure Mode and Effects Analysis (FMEA), and Inspection Management. Transition to a paperless environment and automate your labor-intensive tasks effortlessly. QT9 QMS is ready for immediate use, allowing you to get started quickly. Experience it firsthand by signing up for a free product tour or beginning your free trial today at QT9qms.com. Embrace the future of quality management and elevate your organization's efficiency.

CE Check has undergone a rebranding and is now known as Clever Compliance, offering a more advanced platform designed to manage global product compliance with greater efficiency. This revamped system not only streamlines internal compliance responsibilities but also fosters collaboration among various departments within organizations. Since its transformation in April 2020 into a full-fledged global compliance tool, the previous CE marking software has been discontinued for new users. The CE marking itself is an essential safety indicator for certain products marketed in the EU/EEA, and acquiring this mark is often a legal requirement for those products. To affix the CE marking to your product, one must navigate and successfully complete the CE certification process. Currently, Clever Compliance accommodates the majority of CE marking directives, in addition to several significant non-CE directives, while the platform continues to undergo enhancements with new directives, features, and services to adapt to the changing landscape of compliance requirements. Consequently, users can anticipate a stronger and more adaptable compliance management solution as they move forward with Clever Compliance. This evolution reflects the company's commitment to staying ahead in the rapidly changing world of product compliance.

Link every individual, from entry-level staff to senior management, through our customizable solutions, which are thoughtfully crafted with workflows and features based on industry best practices, enhanced by artificial intelligence, analytics, and mobile technology, all aimed at rapidly improving performance during your digital transformation process. Our solutions are not only effective and adaptable but also incredibly robust, with the ability to be deployed in three months or less, having been developed organically by and for professionals across various sectors to ensure they cater to your specific requirements. Experience an unmatched user experience through the only fully cohesive digital platform focused on Environmental Health and Safety (EHS), Sustainability, and ESG Reporting, alongside related operations, which integrates effortlessly with your existing enterprise systems. Enjoy access to ready-made, best-practice workflows on a platform that does not necessitate version updates, featuring features that allow for rapid deployment and powerful pre-configured options, while also offering the flexibility for customized extensions. Furthermore, enhance engagement and communication among key stakeholders, improving their performance through the most comprehensive integrated Mobile and Analytics platform available in the industry, specifically designed to facilitate your continuous success. This innovation not only supports current needs but also adapts to future challenges and opportunities.

SAP S/4HANA represents a state-of-the-art ERP solution designed specifically for contemporary businesses, seamlessly integrating artificial intelligence and machine learning to boost its functionality. This innovative system offers flexibility in deployment, whether on-premises, via public or private cloud environments, or through a hybrid approach. With a focus on the future, SAP S/4HANA utilizes intelligent technologies such as AI, machine learning, and advanced analytics to facilitate the transformation of business processes through intelligent automation. Leveraging the capabilities of SAP HANA, a premier in-memory database, it provides exceptional real-time processing abilities alongside a simplified data architecture. Users enjoy the freedom to choose from a wide range of features within SAP S/4HANA, applying cutting-edge technologies and automation to fundamentally change their operational workflows. These features span various business areas, including finance, supply chain management, manufacturing, sales, and distribution, thereby ensuring thorough support for organizations. Furthermore, by adopting SAP S/4HANA, companies can significantly improve their agility and adaptability in a rapidly changing market environment, positioning themselves for sustained success. Ultimately, this platform not only enhances efficiency but also empowers businesses to innovate and thrive in their respective industries.

Safexpert, our extensively tested software, is designed for CE marking and conducting risk assessments in accordance with the Machinery Directive, Machinery Regulation, and Low Voltage Directive. This powerful tool includes various modules that assist you and your team in overseeing safety-related projects while adhering to EU directives and standards. It supports professional safety engineering and modern standard management practices. With direct access to comprehensive full-text standards, it enhances the efficiency of your work. The foundational functions of Safexpert revolve around risk assessments, enabling you to create legally mandated evaluations in a systematic, efficient manner that complies with EN ISO 12100. Additionally, the software offers several features aimed at simplifying the risk assessment process for all involved stakeholders, ensuring that compliance is both manageable and straightforward. This commitment to usability makes Safexpert a vital resource for teams focused on safety and regulatory adherence.

Cloud solutions designed specifically for the consumer products industry and their supply chains offer a variety of capabilities including material development, testing, color management, compliance requirements, and collaborative efforts. The Texbase Testing platform significantly reduces the costs associated with data entry while improving the precision and speed of information dissemination, thus helping to prevent expensive delays during the development phase. By consolidating all testing data and related documentation, Texbase establishes a unified repository that encompasses your internal laboratory (if one exists), all supplier data, and independent testing centers. For advanced users, the platform allows for the independent creation of new testing methods and the specification of data parameters without needing support from Texbase, IT teams, or external consultants. Users have the flexibility to either apply existing protocols or develop their own, resulting in rapid and accurate data production irrespective of the source or intended application. In addition, the integration of libraries for fibers, yarns, fabrics, and components provides vital resources for building digital libraries and managing the iterative development process, which in turn accelerates innovation and shortens the time to market. This all-encompassing strategy not only facilitates enhanced collaboration but also significantly boosts overall operational efficiency within the sector, ultimately leading to better product outcomes for consumers.

Maintaining compliance with the standards for Substances of Very High Concern (SVHC) poses an ongoing challenge for companies engaged in chemical production or in manufacturing products that include such substances. The current reliance on manual processes has become increasingly burdensome and intricate due to escalating regulatory requirements and the complexities inherent in the supply chain, leading to significant scalability issues. Businesses must adeptly manage and grow their workloads, especially during peak times like product launches and regulatory submissions. Furthermore, the need for effective communication and coordination with suppliers is essential for navigating these complex supply chains. To tackle these challenges, APA Engineering, with its 19 years of experience in product chemical compliance and a robust global client network, has introduced a web-based SaaS solution aimed at reducing costs and time while improving compliance reporting. The Greencheck software automates and streamlines critical aspects of product chemical compliance, empowering users to access chemical composition information with just one click. Vendors can easily upload data directly, including through Excel files, which facilitates comprehensive compliance reporting via a centralized dashboard that aggregates all pertinent product chemical regulations, making the compliance journey more seamless for all parties involved. This pioneering solution not only simplifies the compliance process but also significantly boosts the overall efficiency of supply chain management, ultimately fostering a more agile and responsive business environment.

We create innovative software solutions that focus on improving sustainability for various organizations. By integrating our advanced technology, you have the opportunity to make a positive impact on the environment while also enhancing your organization's efficiency, durability, and sustainability. Our software supports businesses in overseeing safety and environmental performance, helping them stay compliant, minimize risks, and increase profitability through state-of-the-art technological applications. Protect the well-being and safety of your employees, assets, and the larger community with our specialized health and safety management software. Our solutions cover every aspect of process safety management along with employee health and safety, enabling you to anticipate and prevent incidents, thus safeguarding your workforce and improving overall productivity. Additionally, we ensure that your business operations are reliable and efficient, helping to maintain high productivity levels while allowing you to identify and mitigate risks that could threaten production and manufacturing goals. By implementing these practices, you not only secure your operations but also play a vital role in fostering a more sustainable future for everyone. In this way, our commitment to sustainability aligns with your organizational goals, paving the way for long-term success and environmental stewardship.

At iPoint, we prioritize our customers' needs in every decision and action we take. Our goal is to provide you with a competitive advantage in the complex and constantly changing marketplace. To accomplish this, we have integrated our services into a holistic solution called the iPoint Suite. This suite covers all aspects of the product life cycle, from design and production to usage, recycling, and reuse. As your ideal partner for fully digitalized life cycles of compliant and truly sustainable products, we assist you in transitioning from basic compliance to a deeper level of sustainability, regardless of your starting point. By utilizing your data, you can enhance and optimize your operations, automating and streamlining your processes for greater efficiency. Gain insights into your social, environmental, and economic impacts while strengthening the resilience of your supply chain. By seamlessly integrating the iPoint Suite into your existing IT infrastructure, you can manage data across your organization effectively, promoting efficiency and coherence at every business level. Our innovative solutions will empower you to confidently navigate the intricacies of today’s market demands, equipping you with the tools necessary to thrive in an ever-evolving business environment. Your journey towards sustainable success begins with us, as we provide the guidance and support needed to adapt to future challenges.

The Assent platform stands out in its ability to develop detailed maps of intricate manufacturing supply chains across multiple industries, including aerospace and defense, automotive, electronics, industrial equipment, and medical devices. By managing suppliers, products, and components effectively, we guarantee that your offerings are not only safe and compliant but also environmentally responsible, tackling both product compliance and ESG issues. Assent's distinctive approach to mapping the entire manufacturing genome sets a foundation for authentic supply chain sustainability. With our exceptional access to suppliers and components, even at the minutest level, your business is equipped to thrive, grow, and succeed. Furthermore, we deliver a holistic perspective on sustainability throughout the organization, facilitating the recognition and prioritization of key challenges while keeping you updated on changing regulations through automatic notifications. Assent reveals previously hidden insights, validates beneficial characteristics, and helps mitigate unexpected challenges. By providing solutions that span from product compliance to ESG initiatives, Assent enables the world's leading sustainable manufacturers to flourish. Ultimately, our platform significantly boosts operational transparency and cultivates a culture of innovation and resilience within the manufacturing sector, ensuring that companies can adapt to future demands with confidence. This strategic advantage not only enhances productivity but also positions businesses for long-term success in an ever-evolving marketplace.

We enhance global safety, promote sustainability, and boost productivity. Our software harnesses data from various sources to assist businesses in making informed strategic decisions aimed at reducing risk. This approach is referred to as Integrated Risk Management 4.0 (IRM 4.0). Our track record of success stems from the fact that we have consistently avoided encountering these challenges. Sphera's solutions for Environment, Health, Safety & Sustainability offer comprehensive risk management on a unified platform that can be tailored to fulfill both daily operational and long-term strategic EHS&S objectives. Furthermore, Sphera's Operational Risk Management Solutions empower organizations to establish a cohesive strategy that fosters Operational Excellence across the entire enterprise. In addition, our Product Stewardship Solutions blend top-tier resources and extensive content, enabling compliance while streamlining and automating all facets of a product’s lifecycle, ultimately leading to improved efficiency and effectiveness. By leveraging these innovative solutions, businesses are better equipped to navigate the complexities of risk management in today's dynamic environment.