Top SimplerQMS Alternatives

Intelex provides an integrated software solution designed to manage Environmental, Health, Safety, and Quality (EHSQ) initiatives effectively. Its versatile platform is engineered to gather, control, and analyze EHS and Quality data in a comprehensive manner. This solution is accessible on any device, aligning perfectly with the demands of your workplace. Utilizing Intelex allows your organization to: Enhance the results of your EHSQ program by overseeing workflows for improved performance and control. Identify trends and behaviors through effective goal-setting to enrich insights and enhance decision-making within your EHSQ framework. Reduce incidents and minimize administrative burdens by adeptly supervising, managing, refining, and deriving insights from your safety data with our user-friendly safety software. Streamline the management and reporting of air, water, and waste emissions while overseeing environmental outputs to achieve sustainability goals. Encourage continuous quality improvements by effortlessly recording and tracking all instances of nonconformity within a centralized, web-based system, allowing for trend analysis across multiple departments or locations. Intelex also aids in navigating compliance with global standards and regulations like OSHA, WCB, ISO 45001, EPA, and ISO, fostering a culture of safety and accountability within your organization. By leveraging these tools, companies can not only comply with regulations but also drive long-term growth and sustainability.

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.

AlisQI is a quality management platform for process and batch manufacturers who want to bring more structure, visibility, and control to their operations, without turning quality into a separate administrative burden. Many quality systems focus on documents and events after the fact. AlisQI takes a different approach by connecting quality, lab, and production data into a shared operational context. This makes it easier for teams to understand what is happening in real time, identify emerging issues, and respond before problems escalate. The platform consists of a set of modular quality capabilities, covering areas such as document control, training management, deviations, CAPA, audits, risk management, supplier quality, statistical process control, and EHS. These modules are combined into ready-to-use solutions, called Solvers, that address specific quality and operational challenges in day-to-day manufacturing. Solvers are designed to work from the start and adapt as products, processes, or sites evolve. Changes can be made without custom development, external consultants, or disruptive IT projects, allowing manufacturers to improve continuously while staying compliant by default. AlisQI is used by manufacturing companies across multiple industries to reduce firefighting, improve consistency across sites, and support stable, predictable operations.

isoTracker Quality Management is a widely recognized cloud-based quality management software (QMS) that serves organizations globally in overseeing their compliance with various ISO standards such as ISO 9001, ISO 13485, ISO 22000, ISO 17025, and ISO 14001, among others. This versatile solution is designed as a modular platform, allowing businesses to tailor it according to their unique needs while maintaining a competitive pricing structure and providing exceptional customer support. Organizations can choose from a variety of modules, including Document Control, Complaints, CAPA, Audits, Training, Non-Conformance, and Risk, to create a customized quality management system that addresses all aspects of their operations effectively. By utilizing isoTracker, companies can enhance their quality management processes and ensure ongoing compliance with industry standards.

The SBS QMS Suite is composed of five interrelated software modules designed to enhance Quality compliance efficiency. 1) The SBS Quality Database includes tools for managing CAPA and 8D corrective actions, overseeing nonconformance issues, conducting risk analyses such as FMEA and SWOT, handling various audit management needs, and ensuring Environmental Health and Safety (EHS/HSE) compliance. 2) SBS Ground Control focuses on managing employee training through a Learning Management System (LMS), offering self-paced training options, and providing document control features. 3) SBS Asset Tracking Database oversees calibrated equipment, preventive maintenance schedules, and comprehensive asset inventory management. 4) The SBS Inspection Database captures and records inspection data for incoming materials, in-process checks, and final product assessments, allowing for the generation of real-time SPC charts, development of inspection and control plans, and archiving data for future statistical evaluations. 5) The SBS Vendor Management maintains an approved vendor list (AVL), formulates vendor qualification plans, and tracks the qualification history of suppliers. Each of these modules may be purchased individually or in any combination to meet your needs. On-premise and cloud-based options are available. Free demos are available for download or contact us for a cloud-based demo.

TLM QMS Software is an advanced and reliable platform for quality, risk, and material management that meets validation and 21 CFR Part 11 compliance standards. This innovative, comprehensive quality management system is designed for customization, allowing seamless integration with online CRM solutions, QuickBooks, or ERP systems. Total Lean Management (TLM) QMS Software aims to provide an economical and highly cohesive environment that is adaptable and continuously evolving, enabling the incorporation of specialized systems as necessary to develop a digital business ecosystem tailored to your organization’s workflow requirements. This flexibility ensures that the software can grow alongside your business, responding effectively to changing needs over time.

Dot Compliance has introduced the first ready-to-use Quality Management Solution integrated with the Salesforce.com platform. This innovative solution encompasses a comprehensive array of pre-configured eQMS and compliance processes, allowing clients to implement it swiftly and affordably. Included in the Dot Compliance offerings are complete project validation services alongside product validation packages. Their solution stands out as the most economical option for quality and compliance management in the industry, empowering users to deploy adaptable and scalable solutions without delay. Key quality processes such as Document Management, Training Management, CAPA, Audits, Customer Complaints, Change Management, and Supplier Quality can be automated effortlessly. Furthermore, the solution is designed to be fully configurable and supports seamless integration, which makes it easy for customers to tailor the system to meet their unique specifications. By prioritizing user needs, Dot Compliance ensures a smooth transition and effective management of quality across various operations.

Making data accessible and actionable can be challenging in a manufacturing facility with numerous processes. As operations expand, adhering to safety, quality, and environmental regulations becomes increasingly complex. The manufacturing sector relies heavily on predictability and reliability, as success is rooted in the precise execution of established processes. TenForce was developed based on input from our clients to accurately reflect the operational realities within a plant, ensuring that businesses can navigate these complexities more effectively. By leveraging this feedback, TenForce aims to streamline operations and enhance compliance across the board.

The Qualityze EQMS Suite represents an innovative approach to Enterprise Quality Management Software, tailored for organizations aiming to streamline their quality processes, meet customer demands, and adhere to compliance standards. This software empowers businesses to tackle operational hurdles, thereby enhancing their performance in quality, safety, and reliability. With a variety of pre-defined templates available for controlled documents, audit checklists, regulatory forms, and material compliance reports, it offers comprehensive support. The suite consists of 14 interconnected modules that facilitate a complete quality management system accessible from any location. Built on the robust Salesforce.com technology platform, these modules include Nonconformance Management, CAPA Management, Document Management, Change Management, Audit Management, Training Management, Supplier Quality Management, Inspection Management, Customer Complaints Management, Material Compliance Management, Forms Management, Permit Management, Calibration Management, Maintenance Management, and Field Safety Management. By leveraging our Quality Management solutions, organizations can foster a culture of quality and drive continuous improvements, effectively addressing and mitigating potential quality challenges before they escalate. This proactive approach not only improves overall operational efficiency but also solidifies customer trust and satisfaction.

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.

BPAQuality365 is a quality management system (QMS) software that operates within the secure environment of Microsoft 365 cloud. It utilizes familiar tools that your team already engages with daily, eliminating the need for any alterations to user habits. This modern software is versatile, functioning seamlessly across all devices while being tailored to meet your specific requirements, and it harnesses the latest M365 technologies. The application boasts robust features for managing compliance documents, conducting audits, tracking non-conformances, implementing CAPA actions, and handling processes, process maps, incidents, changes, risks, FMEA, SWOT analyses, equipment, and health, safety, and environmental modules in adherence to ISO 9001, FDA Part 11, and medical regulations. Furthermore, the QMS application integrates smoothly with Teams, allowing users to inquire about the QMS during discussions and easily share QMS cards with colleagues. You can elevate your endeavors toward Quality 4.0 by leveraging advanced AI capabilities alongside superior workflow automation and insightful business intelligence. BPA's status as a Microsoft Preferred partner enables you to tailor your QMS according to your unique demands, collaborate effectively with power users, and deepen your understanding of M365 technologies, ultimately enhancing your organization's overall efficiency and compliance.

QHSE, constructed and managed directly on the Salesforce platform, is recognized as the rapidly expanding Enterprise Quality, Health, and Safety Management System. By integrating EQMS with EHS, Unified QHSE solutions assist businesses of varying sizes in providing safe and sustainable products and services while maintaining high quality standards. These solutions effectively minimize risks and inefficiencies, safeguarding not only the customers and employees but also the integrity of the brand itself. As a result, organizations can operate more seamlessly and confidently in today's competitive market.

Intellect's Quality Management System (QMS) software is demonstrated to enhance quality processes and decrease total quality expenses by as much as 40%. Crafted by certified quality experts, our applications are easily customizable thanks to a user-friendly no-code platform and drag-and-drop features. This contemporary and straightforward solution offers remote access for your team, mobile applications, dynamic workflows, analytics, and comprehensive reporting capabilities. The suite of applications encompasses Document Control, Employee Training, Audit Management, Corrective and Preventive Actions (CAPA), Nonconformance management, along with a range of other beneficial functionalities. With such a versatile toolset, organizations can streamline their quality management efforts and drive significant improvements across various operational areas.

Artintech ERP is an all-inclusive enterprise resource planning system aimed at enhancing and simplifying business functions across multiple departments. Specifically designed for small to medium-sized enterprises (SMEs), it delivers powerful features within a user-friendly framework, enabling organizations to effectively oversee their resources, inventory, workforce, finances, and customer interactions through a single, cohesive platform. Why Opt for Artintech ERP? * Intuitive User Interface: Crafted for simplicity, Artintech ERP reduces the learning curve, facilitating a seamless transition and rapid acceptance throughout your organization. * Flexible Cloud Access: With our secure cloud-based solution, you can access your ERP system from anywhere at any time, providing the convenience to manage your business on the move. * Extensive Support Services: Our committed support team is here to guide you at every stage, from the initial setup through to continuous maintenance and upgrades, ensuring you get the most out of your ERP solution. This level of assistance allows you to focus more on growth and less on technical challenges.

Bringing innovative products to market in heavily regulated sectors often feels like an unending series of compromises. However, MasterControl's GxP software streamlines workflows, ensuring that you don't have to sacrifice quality for cost or innovation in the face of regulation. With a perfect blend of completeness and connectivity, combined with a focus on flexibility and speed, MasterControl Quality Excellence turns quality data and processes into a significant competitive advantage. The journey toward modernizing your manufacturing operations begins with advanced software solutions. MasterControl Manufacturing Excellence simplifies the digital transformation of manufacturing, covering everything from work orders and production records to logbooks and work instructions, making it the most straightforward approach to digitizing your manufacturing processes.

Qualtrax is an advanced software solution designed for quality and compliance that facilitates the management and control of documentation, automates essential business processes, optimizes training management, oversees both internal and external audits, and guarantees adherence to vital industry regulations in real-time. This software proves to be an essential tool for organizations operating within tightly regulated sectors that must comply with standards like ISO 17025, 17020, 13485, 9001, TNI, GFSI, FDA, and FQS. By integrating these functionalities, Qualtrax not only enhances operational efficiency but also helps organizations mitigate risks associated with non-compliance.

Validfor is a powerful and secure digital validation solution that brings all aspects of the validation process into one cohesive, paperless system, designed specifically for industries with stringent regulations. This platform effectively simplifies validation responsibilities while ensuring compliance with essential standards such as GAMP 5, 21 CFR Part 11, and EU Annex 11. By supporting electronic records and sophisticated electronic signatures, Validfor delivers complete audit trails and tailored workflows for different roles, including Author, Reviewer, and Approver, all while ensuring comprehensive CSV compliance. It systematically organizes all documentation and records in a centralized repository, diligently monitoring every change to preserve data integrity and uphold Quality Assurance. Moreover, Validfor includes integrated modules for Change Management, Deviations, Testing, and Periodic Reviews, which aid in conducting seamless impact assessments, tracking Corrective and Preventive Actions (CAPA), managing Computer Software Assurance (CSA), and overseeing audit-ready lifecycles. This all-encompassing strategy not only boosts operational efficiency but also fortifies compliance throughout a wide range of validation activities, making it an indispensable tool for regulated industries. In this way, Validfor empowers organizations to navigate complex regulatory landscapes with confidence and precision.

QEdge by Sarjen Systems is a robust and highly specialized Enterprise Quality Management System (EQMS) specifically engineered for the nuanced requirements of pharmaceutical manufacturing and the broader life sciences industries. This comprehensive solution is designed to meticulously address diverse quality challenges while ensuring unwavering compliance with stringent global regulatory standards such as FDA, EU-GMP, and ICH guidelines. QEdge significantly streamlines and automates a wide array of critical quality processes, including Change Control, Deviation management, Corrective and Preventive Actions (CAPA), efficient Document Management, and structured Training programs. It incorporates key features like robust SOP lifecycle management and SCORM-based eLearning capabilities, enhancing user experience and effectiveness. The system's design ensures audit-ready compliance tracking, contributing profoundly to operational excellence, impeccable data integrity, and regulatory readiness within demanding GxP environments. By facilitating superior process control, automating essential tasks like PQR/APQR, and simplifying vendor qualification, QEdge ultimately drives greater efficiency, mitigates risks, and elevates overall quality management throughout an organization's operations.

An online software solution tailored for medical device manufacturers that streamlines their operations and eases adherence to regulatory standards. This suite features modules such as Audit Management, Corrective and Preventive Actions (CAPA), and Complaint Handling. It has been specifically developed to ensure compliance with ISO 13485 and 21 CFR Part 11 from the outset, providing a robust framework for quality management. Additionally, its user-friendly interface allows companies to efficiently navigate complex compliance requirements while maintaining high standards of product safety and effectiveness.

Workflows are meticulously designed to aid in the preparation of all essential elements needed for a 510(k) submission, while also guaranteeing adherence to the quality record standards outlined in 21 CFR Part 820 as you get ready to launch your device. These workflows are equipped with tools that simplify the creation of vital policies, procedures, and work instructions. In addition, you can keep track of non-conformances, deviations, and CAPAs with custom quality management reports. As your processes develop and improve, automatic training updates ensure your team remains informed. The system also streamlines validation testing for devices, applications, websites, and bespoke software tailored to meet your business requirements. This automation greatly diminishes the time and resources typically needed for comprehensive testing, reporting, and approval tasks. Moreover, you can consolidate all your policies, procedures, and artifacts into standardized documents, making them easily accessible for audit assessments. This solution not only simplifies compliance and validation procedures but also significantly boosts operational efficiency. By integrating such advanced workflows, organizations can enhance their overall productivity and adaptability in a competitive market.

QualityKick is an innovative cloud-based Quality Management System (QMS) specifically designed for the biological sciences industry, aimed at improving compliance and optimizing numerous quality management activities. It is equipped with various modules that tackle essential elements like document control, training, change management, incident tracking, CAPA (Corrective and Preventive Actions), risk assessment, qualification, along with audits for suppliers and equipment. As a web-based solution, it guarantees accessibility from any location and supports all mobile devices, including desktops, smartphones, and tablets. New users enjoy an automated guided tour during their first login, which helps to ease the onboarding process. The platform facilitates document editing through MS Word and offers a customizable review and approval workflow that boosts teamwork and efficiency. Users can tailor various event types, such as deviations, nonconformities, and customer complaints, to meet their specific organizational requirements. Moreover, it empowers users to create CAPA plans, document needed actions, and evaluate their effectiveness, providing a thorough solution for quality management in the pharmaceutical, biotechnology, and medical sectors. With its intuitive interface and comprehensive set of features, QualityKick is set to revolutionize how organizations address quality compliance and enhance their overall operational effectiveness. This innovative approach not only streamlines processes but also fosters a culture of continuous improvement within organizations.

SoftExpert EQM is a comprehensive enterprise quality management software (EQMS) that supports organizations in achieving and maintaining ISO 9001 certification by automating and improving quality processes tailored to their specific products, operations, and business methodologies. This flexible and modular platform consolidates all vital quality initiatives, which encompass process mapping and the management of documented information, such as standard operating procedures, work instructions, and records, in addition to handling non-conformance reports, corrective and preventive actions, and quality metrics. Moreover, the software adeptly manages supplier relationships, resolves customer complaints, conducts quality audits, oversees training and competencies, and assesses quality risks and controls, including quality inspections and statistical process control, thus fostering a more agile and robust quality management system. By optimizing these various functions, SoftExpert EQM enables organizations to significantly elevate their overall quality performance and regulatory compliance, ultimately leading to enhanced customer satisfaction and operational efficiency. This powerful tool not only streamlines processes but also provides valuable insights that help drive continuous improvement initiatives within the organization.

CAQ.Net software solutions are utilized worldwide in scenarios where ensuring the quality, safety, and effectiveness of products and services is crucial. From strategic quality management to operational quality assurance, CAQ.Net enhances process management and encourages a company-wide commitment to quality through its advanced automation and consistent data framework, ultimately aiding in the proactive prevention of failures. This comprehensive approach not only streamlines operations but also fosters a culture of quality throughout the organization.

qmsWrapper is a comprehensive Quality Management Software designed specifically for small businesses and startups. This tool is ideal for organizations aiming to boost efficiency by adhering to ISO 9001:2015 standards, as well as for MedDev creators seeking to seamlessly navigate the requirements of ISO 13485:2016 and 21 CFR 820. It is particularly beneficial for businesses that require assistance in establishing and utilizing an effective, validated Quality Management System. Additionally, it serves companies looking to streamline their quality management processes by transitioning from traditional paper-based methods to automated solutions.

The ZEBSOFT GRC & ISO management platform offers a comprehensive solution for effectively overseeing Governance, Risk, and Compliance. With its user-friendly web interface, ZEBSOFT simplifies the management of various ISO standards, including 9001, 14001, 22301, 27001, and 45001, among others. The platform boasts robust integrated modules that cover Risk, Quality, Environmental issues, Information Security, Compliance, policy templates, document management, and equipment and asset maintenance, including calibration and testing schedules. Enhance your organization’s internal communication, designate responsibilities, and efficiently plan and execute audits. Discover the full capabilities of ZEBSOFT by scheduling a demo today and see how it can transform your compliance processes!

Revolutionize your Life Sciences operations by greatly improving the control, efficiency, and overall quality of both your products and processes. With our fully compliant platform that has undergone pre-validation according to GAMP5 standards, you can consistently maintain inspection readiness. Achieve complete oversight of your processes and documentation, enabling perfectly tailored workflows and maximizing automation wherever possible. Enjoy seamless operations and extensive traceability through our interconnected modules that work in harmony. Our dedicated team is always on hand to respond to any inquiries you may have, ensuring you have the support you need. We are committed to delivering an exceptional Scilife experience that aligns with our high standards! The Scilife platform not only simplifies but also automates and organizes every element of your industry, whether it pertains to Medical Devices, Pharma & Biotech, or ATMP. Click below to discover the specific Scilife modules designed to address the unique lifecycle stages relevant to your field. Our software is fully outfitted with all the crucial quality tools you would expect, along with a host of additional features that exceed your expectations, empowering your operations to flourish. Join us on this exciting journey of transformation, and let’s elevate your capabilities together!

Now you can conveniently connect with your own Quality Management Expert via an online platform specifically created for ease of use. Featuring a variety of ready-made templates that can be smoothly incorporated into your organization, you will be able to enhance operational efficiency. We provide extensive Quality Management Systems and digital solutions that cater to ISO 13485 for Medical Devices and ISO 9001 for General Quality Management, establishing a solid foundation for your quality assurance requirements. By utilizing our services, you can significantly elevate your quality management practices and foster continuous improvement within your organization. Embrace this opportunity to refine your approach to quality management and achieve exceptional standards.

Greenlight Guru stands out as the sole product development and quality management platform tailored exclusively for the medical device sector. This Medical Device Success Platform accelerates the launch of safer products while streamlining adherence to FDA and ISO regulations, serving as a comprehensive hub that integrates all aspects of quality management, including CAPAs, risk assessments, audits, document control, training, and design control. Manufacturers worldwide are transitioning from antiquated paper-based and generic quality systems to Greenlight Guru, aiming not just for compliance but also striving for True Quality in their operations, ultimately enhancing patient safety and product reliability.

Elevate quality standards and ensure adherence to GxP regulations through Vault QMS, which integrates proven best practices and automated workflows to unify all participants, including pharmaceutical and biotech companies, contract manufacturers, and suppliers, into a streamlined quality management system for enhanced oversight and control. This innovative system fosters effortless collaboration across diverse departments, sites, contract manufacturers, suppliers, and testing laboratories, nurturing a culture dedicated to continuous quality improvement. By utilizing automated workflows, organizations can not only increase operational efficiency but also enhance risk visibility across products and processes through a holistic risk management approach. The comprehensive suite of quality applications accelerates processes, boosts productivity, and reinforces GxP compliance throughout all operations. Furthermore, Vault QMS ensures the efficient execution of critical quality management tasks, incorporating built-in best practices for managing deviations, performing internal and external audits, handling complaints, conducting lab investigations, overseeing change control, addressing corrective and preventive actions (CAPA), and facilitating quality risk management, ultimately cultivating a resilient quality culture organization-wide. As a result, businesses are empowered to satisfy compliance mandates while simultaneously improving overall productivity and bolstering their reputation within the industry, leading to sustained success and growth. This commitment to quality excellence not only benefits the organizations but also enhances the trust of stakeholders and consumers alike.

IMSXpress is a sophisticated platform tailored for the administration of document control, the assurance of regulatory compliance, and the management of quality systems in accordance with ISO 13485 and FDA 21 CFR part 820 regulations. It includes a range of features such as document distribution, control, CAPA management, complaint resolution, auditing, training oversight, MDR processes, supplier management, and tracking of non-conforming products. This cutting-edge software is available for either local installation or cloud deployment, and it comes with a variety of pre-built template manuals, procedures, employee training resources, and audit checklists to facilitate a smooth implementation process. Furthermore, its user-friendly interface significantly improves the overall experience, making the management of compliance more streamlined and effective than ever before. Consequently, organizations can ensure they remain up-to-date with regulatory demands while enhancing their operational efficiency.