Alternatives to SimplerQMS

Interfacing’s Integrated Management System (IMS ) is an AI-supported platform that brings BPM, QMS, Document Control, and GRC together in one environment. Teams use IMS to design and manage processes, govern documentation, oversee risks, and demonstrate compliance with complete visibility and reliable audit evidence. Built for sectors that depend on strict oversight, such as aerospace, life sciences, public sector, and financial services, IMS offers real-time monitoring, automated workflows, and AI-driven analytics that strengthen quality and lower operational exposure. The system is ISO 27001 certified and validated for 21 CFR Part 11, ensuring secure and compliant use in regulated operations. IMS also provides low-code automation, process mining, audit tools, training management, CAPA workflows, and dashboards that help organizations improve performance and maintain regulatory control. AI enhances governance, improves precision, and supports continuous compliance.

Intelex delivers a unified software system for overseeing Environmental, Health, Safety, and Quality (EHSQ) initiatives. Its expandable platform is crafted to consolidate, oversee, and scrutinize EHS and Quality data comprehensively. The solution works on any device to meet the realities of your workplace. With Intelex, your organization can: Elevate your EHSQ program outcomes by supervising workflows for superior performance and command. Discern patterns and propensities through goal-setting to deepen understanding and improve decision-making in your EHSQ program. Diminish occurrences and cut down on administrative tasks by efficiently supervising, managing, refining, and extracting insights from your safety data via our intuitive safety software. Simplify the management and reporting of air, water, and waste emissions, and oversee environmental outputs to fulfill sustainability objectives. Foster ongoing improvements in quality by seamlessly logging and monitoring all instances of nonconformity within a unified, web-based system. Investigate trends across various departments, sites, or locations. Intelex can help you manage compliance with international standards and regulations such as: OSHA, WCB, ISO 45001, EPA, ISO

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.

AlisQI is a cloud-based Quality Management platform built for process and batch manufacturers who want to move beyond reactive firefighting toward stable, predictable operations while maintaining full compliance control. Rather than organizing quality around static documents and isolated events, AlisQI was designed as a data-first system. Quality, laboratory, and production data are structured and connected in a shared operational backbone. This gives cross-functional teams early visibility into deviations, faster response times, and greater confidence in product integrity and daily execution. The platform combines configurable quality modules, including document control, training, deviations, CAPA, audits, risk management, supplier quality, SPC, and EHS, with targeted, ready-to-use Solvers. Solvers integrate forms, workflows, dashboards, and business logic to address specific operational problems without unnecessary scope. Because the system is built on structured data, manufacturers can apply practical AI within workflows, from automated COA extraction to conversational access to quality data and pattern detection across incidents. Solvers are production-ready from day one and evolve as processes, products, or plants change. This progression does not require custom development or disruptive IT projects. Manufacturers use AlisQI to harmonize quality practices across sites, reduce waste and rework, strengthen audit readiness, accelerate root cause analysis, and connect shop-floor and lab data directly to quality decision-making across industries including chemicals, plastics, packaging, food and beverage, personal care, automotive, and industrial manufacturing.

isoTracker Quality Management is a popular cloud-based quality management software (QMS) system. It is used on a worldwide basis by businesses to manage their ISO 9001, ISO 13485, ISO 22000, ISO 17025, ISO 14001 systems...plus many others. It is a modular product which can be configured to meet an organization's specific requirements and is competatively priced with superg customer support. Any module combination of Document Control, Complaints, CAPA, Audits, Training, Non-Conformance and Risk can be subscribed to.

The SBS QMS Suite consists of 5 software modules that work together for efficient Quality compliance: 1) SBS Quality Database - CAPA / 8D corrective and preventive actions (CAR) with root cause analysis - Nonconformance management - Risk analysis including FMEA, SWOT, interested party risk register - Internal, customer, and third-party audit management - Environmental Health and Safety (EHS / HSE) management 2) SBS Ground Control - Employee training management (LMS) - Self-Paced training - Change control - Document control 3) SBS Asset Tracking Database - Calibrated equipment control - Preventive maintenance - Asset inventory management 4) SBS Inspection Database - Record incoming material, in process, and final product inspection data - Generate real time SPC charts - Inspection plans and Control Plans - Archive data for further statistical analysis 5) SBS Vendor Management - Maintain an approved vendor list or AVL - Develop vendor / supplier qualification plans - Maintain vendor / supplier qualification history Modules may be purchased separately or in any combination. On-premise and cloud-based options are available. Free demos are available for download or contact us for a cloud-based demo.

Dot Compliance offers the industry's first ready to use Quality Management Solution powered by the Salesforce.com platform. The Dot Compliance solution includes an extensive set of off-the-shelf ready eQMS and compliance pre-configured processes, enabling customers to deploy quickly and cost effectively. Dot Compliance ready to use solutions include full project validation services and product validation packages. Dot Compliance offers the industry’s most cost-effective quality and compliance management solution available, allowing users to quickly deploy flexible and scalable solutions. Automate core quality processes such as Document Management, Training Management, CAPA, Audits, Customer Complaints, Change Management, Supplier Quality, and more. Our solution is fully configurable and offers seamless integration abilities, with easy adaptation and implementation of customer’s specific requirements.

TLM QMS Software is a powerful and robust quality, risk and material management software (QMS) which is validated and 21 CFR Part 11 compliant. TLM is a cutting-edge, all-in-one quality management system that can be customized to integrate with online CRM software, QuickBooks or ERP databases. Total Lean Management (TLM) QMS Software is specifically intended to be a low cost, highly integrated, flexible and continuously improving landscape to which specialty systems can be added where needed to create the digital business landscape that enables work flows the way your company needs them to work.

Qualityze EQMS Suite is a next-generation Enterprise Quality Management Software. It is specifically designed for businesses to efficiently manage their quality processes, customer expectations and compliance requirements. It helps them address operational challenges so they can achieve excellence in terms of quality, safety and reliability. It comes with pre-defined templates for controlled documents, audit checklists, regulatory forms, material compliance reports and many more. Qualityze EQMS Suite is a set of 14 integrated modules that help create a closed-loop system to manage end-to-end quality from anywhere. Our range of smarter quality solutions is built on the Salesforce.com technology platform. These modules are 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, and Maintenance Management, Forms Management and Field Safety Management. Our Quality Management solutions help create a culture of quality and continuous improvements by proactively mitigating quality issues.

It is difficult to make data available and actionable when a manufacturing site has many processes. As operations grow, it is becoming more difficult to comply with safety, quality, and environmental regulations. Manufacturing is built on predictability and reliability. Manufacturing by nature is all in the execution of established processes. TenForce was built from the feedback of our clients to map the operational reality in a plant.

BPAQuality365, a QMS software, can be used in your secure Microsoft 365 cloud. It leverages tools used daily by collaborators and does not require you to change your user habits. It is modern, compatible with all devices, adaptable to your specific needs, and powered through innovative M365 technologies. The app includes powerful compliance document management, audit, non-conformance, CAPA action, process and process maps, incident, change, risk, FMEA, SWOT, equipment, health, safety, environment modules compliant with ISO 9001, FDA Part 11 and medical regulations. The QMS app integrates with Teams discussions and users can ask the QMS while chatting in Teams and share QMS card with their colleagues. You can go further to achieve your Quality 4.0 goals by combining powerful AI features with best-in-class workflow automation and business intelligence. BPA's Microsoft Preferred status allows you to customize your QMS to meet your needs, share knowledge with your power users, and learn about M365 technologies.

Unify quality processes with QT9's all-in-one cloud-based QMS Software Suite. QT9 QMS is a user-friendly quality management software that includes 25+ modules with unlimited scalability. Automate ISO & FDA Compliance with email alerts, To Do lists and FDA 21 CFR Part 11 Compliant Electronic Approvals. QT9 QMS enables Life Sciences, Biotechnology Companies, Medical Device Manufacturers and Pharmaceutical Companies to digitally transform operations. Get real-time status updates and visualize quality metrics up-to-the-minute. QT9 QMS comes with built-in document control, revision-level controls, corrective actions (CAPAs), Nonconforming products and more. Advance product releases with Deviation Management, Engineering Change Orders, FMEA, Inspection Management Modules Included. Go paperless & put time-consuming tasks on autopilot. QT9 QMS comes ready-to-use. Get a free product tour! Start a Free Trial. Visit QT9qms.com

Artintech ERP is a comprehensive enterprise resource planning solution designed to optimize and streamline your business operations across various departments. Tailored for small to medium-sized enterprises (SMEs), Artintech ERP offers robust functionality with a user-friendly interface, allowing businesses to seamlessly manage their resources, inventory, human capital, finances, and customer relations all in one integrated platform. Why Choose Artintech ERP? * User-Friendly Interface: Designed for ease of use, Artintech ERP minimizes the learning curve, ensuring a smooth transition and quick adoption across your organization. * Cloud-Based Flexibility: Access your ERP system anytime, anywhere, with our secure cloud-based solution, which provides the flexibility to manage your business on the go. * Comprehensive Support: Our dedicated support team is available to assist you every step of the way, from initial implementation to ongoing maintenance and updates.

Natively built and operated on the Salesforce platform, QHSE is the fastest growing Enterprise Quality, Health and Safety Management System. Unified QHSE solutions combine EQMS with EHS to help customers of all sizes deliver high quality products and services in a safe and sustainable manner. They reduce risk, inefficiencies, and inefficiencies, while protecting their customers, employees, and brand.

Qualtrax is a quality and compliance software program that can manage and control documentation, automate key business processes, streamline training management, manage external and internal audits, and ensure that critical industry regulations are met in real time. Qualtrax is a valuable resource in highly-regulated industries where compliance with standards such as ISO 17025 and 17020, 13485 and 9001, TNI and GFSI, FDA and FQS are required.

Intellect's QMS software has been proven to improve quality operations and reduce overall quality cost by up to 40%. Our apps were designed by certified quality professionals and can be easily customized with our no-code platform or drag-and-drop technology. Remote access for your team, mobile apps, dynamic workflows, analytics, reporting, and remote access are all possible with this modern and simple solution. Apps include Document Control and Employee Training, Audit Management CAPA, Nonconformance, as well as other useful features.

QualityPro by TecWork is an 𝐞𝐧𝐭𝐞𝐫𝐩𝐫𝐢𝐬𝐞-𝐠𝐫𝐚𝐝𝐞 𝐰𝐞𝐛/𝐜𝐥𝐨𝐮𝐝-𝐛𝐚𝐬𝐞𝐝 𝐐𝐮𝐚𝐥𝐢𝐭𝐲 𝐌𝐚𝐧𝐚𝐠𝐞𝐦𝐞𝐧𝐭 𝐒𝐲𝐬𝐭𝐞𝐦 (𝐐𝐌𝐒) designed to help manufacturing, automotive, and regulated organizations digitize, automate, and scale quality operations with confidence. Built to eliminate disconnected spreadsheets and document-heavy processes, QualityPro unifies critical quality workflows into a single intelligent platform that delivers end-to-end compliance, workflow automation, and real-time operational visibility. The platform centralizes essential quality processes including Nonconformance and Deviation Management, 𝐂𝐨𝐫𝐫𝐞𝐜𝐭𝐢𝐯𝐞 𝐚𝐧𝐝 𝐏𝐫𝐞𝐯𝐞𝐧𝐭𝐢𝐯𝐞 𝐀𝐜𝐭𝐢𝐨𝐧𝐬 (𝐂𝐀𝐏𝐀), Complaint Handling, Audit Management, Document Control, Change Management, Risk Assessment, Training and Competency Tracking, Calibration, and Inspection Management. Configurable workflows, automated alerts, audit trails, and centralized dashboards help teams stay audit-ready while reducing manual effort and compliance bottlenecks. Designed for 𝐈𝐒𝐎-𝐜𝐞𝐫𝐭𝐢𝐟𝐢𝐞𝐝 𝐚𝐧𝐝 𝐜𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞-𝐝𝐫𝐢𝐯𝐞𝐧 𝐦𝐚𝐧𝐮𝐟𝐚𝐜𝐭𝐮𝐫𝐞𝐫𝐬, QualityPro supports global standards such as 𝐈𝐒𝐎 𝟗𝟎𝟎𝟏, 𝐈𝐀𝐓𝐅 𝟏𝟔𝟗𝟒𝟗, 𝐈𝐒𝐎 𝟏𝟑𝟒𝟖𝟓, 𝐚𝐧𝐝 𝐅𝐃𝐀 𝟐𝟏 𝐂𝐅𝐑 𝐏𝐚𝐫𝐭 𝟏𝟏. Whether operating as a single site or multi-location enterprise, organizations gain structured governance, improved accountability, and measurable quality performance improvements. QualityPro empowers leadership teams with actionable insights, strengthens regulatory compliance, reduces operational risk, and fosters a 𝐜𝐮𝐥𝐭𝐮𝐫𝐞 𝐨𝐟 𝐜𝐨𝐧𝐭𝐢𝐧𝐮𝐨𝐮𝐬 𝐢𝐦𝐩𝐫𝐨𝐯𝐞𝐦𝐞𝐧𝐭, transforming quality management into a strategic competitive advantage.

It can seem like a never-ending series of tradeoffs to bring breakthrough products to market within highly regulated industries. MasterControl's GxP software simplifies workflows, so you don't have to compromise quality for cost or innovation with regulation. Complete and connected meets flexible and fast. MasterControl Quality Excellence transforms quality data and processes to a competitive edge. Modern software is the first step in modernizing your manufacturing operations. MasterControl Manufacturing Excellence, from work orders to production records (EBR/eDHR), to logbooks and work instructions, is the easiest way to digitalize manufacturing.

Validfor is a robust and secure digital validation platform that consolidates the entire validation process into a single, paperless system, specifically tailored for industries that are heavily regulated. This platform not only streamlines validation tasks but also guarantees adherence to critical standards such as GAMP 5, 21 CFR Part 11, and EU Annex 11. With capabilities for handling electronic records and advanced electronic signatures, Validfor ensures complete audit trails, role-specific workflows (including Author, Reviewer, and Approver), and thorough CSV compliance. It securely organizes all documentation and records within a centralized repository, meticulously tracking every modification to maintain data integrity and uphold Quality Assurance. Additionally, Validfor provides integrated modules for Change Management, Deviations, Testing, and Periodic Reviews, thereby facilitating smooth impact assessments, tracking of CAPA, Computer Software Assurance (CSA), and management of audit-ready lifecycles. This comprehensive approach not only enhances operational efficiency but also strengthens compliance across various validation activities.

Sarjen’s Quality Management Software brings transformative intelligence to how organisations manage quality, compliance, and continuous improvement. Built for regulated industries like pharmaceuticals, life sciences, and manufacturing, this solution goes beyond traditional quality systems by embedding AI at its core. Rather than merely storing documents and checklists, AI continuously analyses quality data from processes, deviations, audits, customer feedback, and supplier performance to surface meaningful patterns and risks. By leveraging machine learning, the system identifies early signals of quality drift that manual reviews can miss, and predicts potential non-conformances before they escalate into serious issues.AI-driven insights provide context-aware recommendations that empower quality teams to act smarter and faster, reducing investigation cycles and eliminating repetitive manual work. Intelligent alerts help prioritise what matters most, while automated trend analysis highlights areas for improvement without waiting for periodic reviews. The software also supports root cause analysis with AI-augmented suggestions, helping teams uncover hidden correlations across data sources.With built-in compliance workflows and adaptive quality controls, the system ensures consistent adherence to industry regulations while learning from operational data to become more accurate over time. Through advanced visualisation, interactive dashboards, and predictive quality metrics, stakeholders get a real-time understanding of quality health at every level of the business. The result is a proactive, resilient quality ecosystem where AI amplifies human expertise rather than replacing it.

A web-based software suite for medical device companies that automates their processes and simplifies regulatory compliance. Modules include Audit Management, CAPA and Complaint Handling. Designed from the start for ISO 13485 compliance and 21 CFR Part 11 compliance.

Workflows are specifically developed to assist you in preparing all necessary components for a 510(k) submission, while also ensuring compliance with the quality record requirements set forth in 21 CFR Part 820 as you prepare to market your device. These workflows come equipped with tools to facilitate the drafting of essential policies, procedures, and work instructions. Furthermore, you can monitor non-conformances, deviations, and CAPAs through tailored quality management reports. As your processes evolve and enhance, you can ensure your team receives automatic training updates. The system also automates validation testing for devices, applications, websites, and custom software tailored to your business needs. This automation significantly reduces the time and resources that would otherwise be consumed by extensive testing, reporting, and approval processes. Additionally, you can compile all your policies, procedures, and artifacts into standard documents, making them readily available for audit evaluations. Overall, this solution streamlines the compliance and validation processes, thereby enhancing operational efficiency.

QualityKick is a cloud-based Quality Management System (QMS) tailored for the biological sciences sector, designed to enhance compliance and streamline various quality management processes. It offers a suite of modules, each addressing critical components such as document control, training, change management, incident tracking, CAPA (Corrective and Preventive Actions), risk evaluation, qualification, and supplier and equipment audits. Being a web-based platform, it ensures accessibility from any location and on any mobile device, including computers, smartphones, and tablets. New users benefit from an automated guided tour upon their initial login, facilitating a smoother onboarding experience. The system supports document editing with MS Word and enables a customizable review and approval workflow, enhancing collaboration and efficiency. Various event types, including deviations, nonconformities, and customer complaints, can be configured to suit organizational needs. Additionally, it allows users to establish CAPA plans, document necessary actions, and assess their effectiveness, making it a comprehensive solution for quality management in the pharmaceutical, biotechnology, and medical fields. With its user-friendly interface and robust features, QualityKick is poised to transform how organizations manage quality compliance.

SoftExpert EQM stands out as an all-encompassing enterprise quality management software (EQMS) that aids organizations in obtaining and upholding ISO 9001 certification by automating and enhancing quality processes specifically designed for their unique products, operations, and business practices. This modular and adaptable platform integrates all essential quality initiatives, including process mapping and the management of documented information such as standard operating procedures, work instructions, and records, along with non-conformance reports, corrective and preventive actions, and quality indicators. Furthermore, the software efficiently oversees supplier relationships, addresses customer complaints, conducts quality audits, manages training and competencies, and evaluates quality risks and controls, as well as quality inspections and statistical process control, all of which contribute to a more agile and resilient quality management system. By streamlining these diverse functions, SoftExpert EQM empowers organizations to enhance their overall quality performance and compliance.

CAQ.Net software solutions are in action all around the globe wherever it is important to ensure the quality, safety, and functionality of products and services. Whether strategic quality management or operational quality assurance – thanks to its high degree of automation and uniform data structure, CAQ.Net facilitates effective process management, proactive failure prevention, and a company-wide quality mindset.

qmsWrapper is an interconnected Quality Management Software for startups and small businesses. It helps all companies that want to increase productivity with ISO 9001:2015 and MedDev creators to easily achieve and manage ISO 13485:2016 and 21 CFR 820. Best For 1. For companies who need guidance to implement and adopt validated QMS. 2. For companies who want to automate their quality management and go beyond a paper-based system.

Transform your Life Sciences operations by significantly enhancing the control, efficiency, and quality of your products and processes. Maintain inspection readiness consistently with our fully compliant platform, which has undergone pre-validation in line with GAMP5 standards. Gain complete oversight of your processes and documentation, allowing for perfectly customized workflows and maximized automation wherever feasible. Experience smooth operations and comprehensive traceability through our seamlessly connected modules. Our committed team is available to address any inquiries you may have at any moment. Only the finest Scilife experience meets our high standards! The Scilife platform not only streamlines but also automates and organizes every aspect of your industry, whether in Medical Devices, Pharma & Biotech, or ATMP. Click below to explore the specific Scilife modules that cater to the distinct lifecycle stages within your industry. Our software is not just equipped with all the essential quality tools you would anticipate; it also comes with numerous additional features that surpass expectations, ensuring your operations thrive. We're excited to partner with you on this transformative journey!

ZEBSOFT GRC & ISO management platform is a holistic approach for managing Governance, Risk & compliance. ZEBSOFT's intuitive web interface makes it easy to manage ISO standards (9001, 14001 and 22301), 27001, 27001 and 45001 and many others. ZEBSOFT has powerful integrated modules for Risk, Quality, Environmental, InfoSec, Compliances, policies (templates included) & documents, equipment & asset management with maintenance/calibration/testing planning. Improve internal communication, assign ownership, plan, and conduct audits. To see the full potential of ZEBSOFT, book a demo today!

You can now access your personal Quality Management Expert through an online platform designed for your convenience. With ready-to-use templates that can be seamlessly integrated into your organization, you can ensure efficient operations. Our offerings include comprehensive Quality Management Systems and digital solutions tailored for ISO 13485 related to Medical Devices, as well as ISO 9001 for General Quality Management, providing a robust framework for your quality assurance needs. Take advantage of our services to elevate your quality management practices to new heights.

Greenlight Guru is the only product development and quality management platform designed specifically for medical device companies. The Medical Device Success Platform helps companies get safer products to market faster, simplifies FDA and ISO regulatory compliance, and provides a single source of truth by connecting the management of all quality processes like CAPAs, risk, audits, document control, training, design control, and more. Device makers across the globe are replacing their outdated paper-based and general-purpose legacy quality systems with Greenlight Guru to push beyond baseline compliance and achieve True Quality.

Transform your operations into a digital framework that prioritizes security, environmental responsibility, quality, and hygiene within your business. By centralizing, simplifying, and automating processes through a single tool, you can achieve sustainable performance for your organization. The effectiveness and safety of your enterprise hinge on streamlined automated processes, and BlueKanGo presents itself as the comprehensive digital EHSQ solution for managing these essential functions. If you're aiming to tackle societal and environmental challenges, mitigate risks, and enhance operational excellence, trust the platform that over 3,500 customers have relied on for more than 18 years. Embrace the digitization of your quality management, EHS initiatives, and much more, covering aspects like quality audits, employee health and safety, environmental compliance, CMMS, inspections, certifications, standards, corporate social responsibility, regulatory oversight, and strategic planning. Our six key differentiators highlight our strengths in the industry. With over 18 years in the market, BlueKanGo stands as a SaaS platform limited only by your creativity, offering an innovative, scalable, and comprehensive solution designed to adapt to your organization's evolving needs. The future of your business processes starts with a commitment to digital transformation and a partnership with BlueKanGo.

IMSXpress is an advanced platform designed for managing document control, ensuring regulatory compliance, and overseeing quality systems in alignment with ISO 13485 and FDA 21 CFR part 820 standards, incorporating features such as document distribution, control, CAPA management, complaint handling, auditing, training management, MDR processes, supplier oversight, and non-conformance product tracking among others. This state-of-the-art software can be deployed either as a local installation or through cloud hosting, and it is conveniently equipped with ready-made template manuals, procedures, employee training materials, and audit checklists to streamline implementation. Additionally, its intuitive interface enhances user experience, making compliance management more efficient than ever.

MediaLab's Intelligent Quality Engine (IQE) solution is designed to deliver powerful automation for laboratory non-conforming event management processes. IQE eliminates the need for paper-based, manual investigation and CAPA processes while reducing cost and supporting the quality improvement program. IQE helps your laboratory follow corrective and preventive action standards as outlined by CAP, joint commission, ISO, and other accrediting bodies. You'll benefit from a streamlined approach that supports your regulatory compliance. Start by using our online form templates, or create your own. Allow employees to create events as problems arise. MediaLab will route your event through each phase of the event management lifecycle, from initial event description to risk analysis, closure, and change effectiveness evaluations. Your current processes and forms work beautifully in IQE.

Enhance quality and ensure GxP compliance through Vault QMS, which integrates established best practices and automated workflows to connect all stakeholders, including pharmaceutical and biotech firms, contract manufacturers, and suppliers, into cohesive quality processes for improved oversight and control. This system facilitates seamless collaboration among various departments, sites, contract manufacturers, suppliers, and testing labs, promoting a culture of continuous quality enhancement. By leveraging automated workflows, organizations can achieve greater operational efficiency while simultaneously improving risk visibility throughout products and processes via a consolidated risk management strategy. The unified suite of quality applications accelerates speed, boosts efficiency, and strengthens GxP compliance across all activities. Additionally, Vault QMS allows for the smooth implementation of essential quality management processes, incorporating built-in best practices for handling deviations, conducting internal and external audits, managing complaints, executing lab investigations, overseeing change control, addressing CAPA, and facilitating quality risk management, ultimately fostering a robust quality culture across the organization. By doing so, businesses can not only meet compliance requirements but also enhance their overall productivity and reputation in the industry.

Software that helps you comply with regulations. Fannie Mae, Wendy's and Walmart trust the best mobile inspection and audit platform. This will help you improve safety and accuracy. The #1 field management platform for teams, FORM OpX will transform your Excel, paper, and digital processes. FORM OpX combines advanced data gathering and configurable workflows with powerful operational insight to increase compliance in real time. To ensure compliance and team compliance, you can set up audits, inspections, or workflows. Digital forms allow you to capture data and guide teams to the right actions. Set up automated alerts and escalates to prompt corrective action when issues arise. You can save time and money by creating customizable workflows that improve processes, increase compliance, and reduce errors.

These proven solutions will help you operationalize your pandemic response plan, monitor and report on your employees' and visitors' health, and increase your business' productivity. Engage employees, improve workflows and increase data visibility at all levels of your company to improve safety culture. Cority helps you to break down silos within departments, improve reporting, achieve operational excellence, and increase productivity. Cority's unified compliance management system is designed to take the guesswork out compliance. myCority connects your frontline employees, no matter their location, with the tools they need in order to reduce risk and drive compliance. EHSQ experts develop, implement, and support the Cority solution. We are the industry leader in Occupational Health, Industrial Hygiene and Employee Health solutions. You can take your safety programs to the next step by proactive mitigating risks, managing compliance and reducing incidents.

ACE Essentials is the pre-validated Electronic Quality Management System Software (EQMS) designed for highly regulated industries. ACE Essentials includes 10 workflows, as well as all the required Standard Operating Procedures (SOPs) and Policies. This ensures that your quality management system is fully compliant from the start. ACE Essentials features include a complete audit trail that tracks every action within the system. This allows you to understand the risks associated assets. Features of ACE Essentials Pre-Configured Workflows Pre-Configured Event Management (Due dates, Scheduling, Reminders) - Pre-Configured Permission Based Security - Pre-Configured Full Documentation - 50+ documents - Multiple Site Capability - No Charge Upgrades for the Product's Life Pre-Configured Tasks Liste - No Validation Period Pre-Configured In System Notifications Pre-Configured Email Notifications

Mitigate losses and minimize risk occurrences through proactive risk visibility. Foster a contemporary and cohesive risk management strategy that leverages real-time, consolidated risk intelligence to assess their influence on business goals and investments. Safeguard your brand’s reputation, reduce compliance costs, and cultivate trust among regulators and board members. Keep abreast of changing regulatory demands by actively managing compliance risks, policies, case evaluations, and control assessments. Promote risk-conscious decision-making and enhance business performance by aligning audits with strategic priorities, organizational goals, and associated risks. Deliver prompt insights on potential risks while bolstering collaboration among different departments. Decrease vulnerability to third-party risks and enhance sourcing choices. Avert incidents related to third-party risks through continuous monitoring of compliance and performance. Streamline and simplify the entire lifecycle of third-party risk management while ensuring that all stakeholders are informed and engaged throughout the process.

The Audit Manager software facilitates comprehensive quality management by enabling the digital oversight of audits, quality controls, and testing throughout all stages, including planning, checklist creation, evidence collection, field surveys, and the management of nonconformities. Users can easily access the calendar to schedule audits while attaching essential details such as the subject, checklist, lead auditor, co-auditor, and participants. Both internal and external personnel can receive timely email invitations and view the audit schedule directly through the application. After completing the inspection, users can generate audit reports in PDF or Excel formats and share them instantly with company management or relevant stakeholders via mobile. All minutes are neatly archived and accessible, ensuring that they can be seamlessly integrated into the document repositories utilized by the organization, enhancing overall efficiency and accountability in the audit process. This streamlined approach not only saves time but also improves communication among all parties involved.

What is QMS Audit Pro? QMS Audit Pro is an online platform for issue capture, auditing and corrective actions that is used over 15,000 times per month. QMS Audit Pro allows your team to collect consistent data, standardize operations and send reports. It also helps you identify problems and resolve them. It's also completely free. There are no contracts or commitments. You can cancel at any time. You can create Audit Plans, conduct Audits, monitor non-conformances, and track them all within one tool, achieving End-to-End traceability. Create company-wide audit and checklist templates that can be reused when performing audits. Make an audit report that includes pertinent information, such as audit summary, nonconformances and audit participants. This report can be customized to meet the needs of your company. You can quickly and confidently take action by linking data sources from various modules into powerful dashboards.

1factory's Manufacturing Quality is a versatile quality control software designed for manufacturing businesses of various scales, available in both cloud-based and on-premises formats. This robust and dependable solution offers a comprehensive suite of features, including first article inspections, factory monitoring, quality control plans, as well as in-process and final inspections. Furthermore, it also covers incoming inspections, inspection management, corrective and preventive actions (CAPAs), and non-conformance tracking, among others. Additional noteworthy functionalities comprise the ability to perform metrics calculations for Process Performance (Pp, Ppk) and Process Capability (Cp, Cpk), along with managing variation and SPC control, as well as monitoring defect risks effectively. By integrating these capabilities, 1factory’s Manufacturing Quality ensures that manufacturers maintain high standards of quality throughout their operations.

IMSXpress ISO 9001 serves as comprehensive software for document control and quality system management. Users can install the IMSXpress client on individual PCs or on a Windows server, which allows for distribution to users through remote desktop services as a remote application. The underlying database operates on MS SQL and can be set up on any version from MS SQL Server 2014 onward, with access to the IMSXpress application available across various network types. Options for remote access include setting up your own network, utilizing the cloud-based hosting service, or opting for an online subscription package. The system features a fully automated training module that includes self-training, integrated document training, and job descriptions, among other resources. It is designed to facilitate changes in documents, engineering, and processes, enabling users to create fillable PDF templates, populate them with data, and generate records effortlessly. Additionally, IMSXpress is useful for scheduling maintenance tasks, managing spare parts inventory, and overseeing complaints, non-conformities, risk management, and audit findings. This versatility ensures that organizations can maintain high standards in quality management while streamlining their operational processes.

Agatha provides a comprehensive range of cloud-based solutions specifically designed for the life sciences sector, facilitating the centralized oversight of documents and processes related to clinical operations, quality assurance, regulatory compliance, and training activities. This platform caters to the workflows of biotech firms, pharmaceutical companies, medical device manufacturers, and contract research organizations by offering various modules, including eTMF (Inspection-Ready Master Trial File), Remote ISF (Investigator Site File) management, and tools for creating and approving standard operating procedures (SOPs) as well as managing quality documents related to CAPAs, deviations, and change controls. Additionally, Agatha enhances regulatory document handling, ensuring smooth document creation, review, approval, storage, and sharing within a single cohesive system. By promoting a paperless approach, it alleviates administrative burdens and bolsters data security, while being constructed on a global-compliance framework that meets critical standards such as 21 CFR Part 11, GDPR, and EU Annex 11. Ultimately, Agatha empowers life sciences organizations to optimize their operations and maintain compliance with industry regulations more efficiently.

SolvoNext – NCR CAPA empowers small and medium-sized factories to replace outdated paper-based NCR and CAPA processes with a robust, digital-first solution. The platform guides teams through a structured workflow—starting with NCR initiation, moving through root cause analysis, recording financial data, and ending with secure approvals—all while maintaining a complete knowledge library. Interactive dashboards display key metrics like NCR status, departmental tracking, and monthly progress, helping leaders make quick, data-backed decisions. Its COPQ tracking feature calculates the financial toll of inefficiencies, waste, and defects, giving organizations a clearer view of quality performance. Built-in quality tools such as the 5 Whys and Fishbone diagrams make problem-solving systematic and collaborative. Users can assign role-based permissions, manage multi-level approvals, and receive automated alerts for faster communication. Optional AI integration enhances the platform with predictive analytics, advanced diagnostics, and automated reporting tailored to each plant’s needs. SolvoNext ultimately improves compliance, transparency, and operational efficiency across all manufacturing environments.

Quality Collaboration By Design (QCBD) offers a comprehensive quality management software solution tailored for the manufacturing sector. This cost-effective, Windows-compatible application streamlines the process of obtaining and sustaining compliance with various quality management standards, including ISO 13485, ISO 9001, TS 16949, AS9100, and SQF 2000 / ISO 22000. Developed by CAMA Software, QCBD encompasses a wide range of modules that facilitate training management, supplier oversight, process deviation tracking, document control, equipment management, and additional functionalities. With its user-friendly interface, QCBD not only enhances operational efficiency but also ensures that businesses can easily adapt to evolving quality requirements.