Alternatives to Total Lean Management (TLM) Software

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

ReliaSoft provides a powerful set of reliability software solutions that facilitate a comprehensive range of reliability engineering modeling techniques and analysis techniques. We are the leading provider of reliability solutions for product testing, design, maintenance strategies and optimization. Our products support a variety of reliability and maintainability techniques, including life data analysis, accelerated lifetime testing, system modeling and RAM analysis. We also support reliability growth, FRACAS analysis, FMEA analysis and RCM analysis. These tools help you improve the reliability of your products and processes, and optimize maintenance planning.

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

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.

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.

Adaptive Compliance Engine® (ACE®) is a highly configurable, workflow based eQMS/eDMS and more that can adapt to any business process, allowing for real-time tracking, management, and reporting of all compliance, quality, and operational activities. With ACE®, you will minimize the administrative hassles and maximize ROI with productivity gains from day one – all while 21 CFR Part 11 compliant. Our one-stop software includes: -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 so much more! Empower all levels of your organization with intuitive user interfaces, easily search for all your documents and records, and transform your data into actionable intelligence with advanced analytics all on a single platform. ACE comes with everything you need, all included at one price. Every application is included, no more a la carte pricing. No more nickel and diming. One software, endless solutions.

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.

SimplerQMS offers a cloud-based Quality Management Software, specifically designed for the Life Science industry. SimplerQMS helps ensure compliance with various regulatory requirements, including FDA 21 CFR Part 11, EU Annex 11, GxP, cGMP, GAMP 5, GDPR, EU IVDR & EU MDR, ISO 13485:2016, 21 CFR Part 820, and ICH Q10, among others. The system is fully validated according to GAMP5. The system offers a range of Life Science QMS modules such as Document Control, Change Control, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, Quality KPIs and more. SimplerQMS integrates with Microsoft Office and allows users to work with documents in applications such as Word, PowerPoint, and Excel. Overall, SimplerQMS delivers efficient, paperless workflows that align with the compliance requirements of the Life Science industry.

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.

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.

The SBS QMS Suite consists of 5 software modules that work together for efficient Quality compliance: 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 SBS Ground Control - Employee training management (LMS) - Self-Paced training - Document control SBS Asset Tracking Database - Calibrated equipment control - Preventive maintenance - Asset inventory management 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 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.

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

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.

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.

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.

Qualcy Biomed QMS Software was designed for Bio-Medical businesses (including Biotech and Pharma) to manage QMS records in accordance with FDA and ISO13485 requirements. * Meets 21 CFR Part 820 requirements * Features include E-sign, audit trails, and compliance with 21 CFR part 11. This software manages Doc. Change control, complaints, audits CAPA, NC Records Training Records and many more.

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.

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.

Qualio is a one-stop solution for quality and compliance management. It's ideal for growing companies in healthcare and life sciences. Qualio is reliable, affordable and easy to use. It helps companies build life-saving products faster and achieve 100% ISO, GxP and FDA compliance. Qualio makes it easy for companies to manage document control, training and NCRs, audits as well as suppliers, complaints, and other tasks in one platform.

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.

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.

Digitize your processes. Security. Environment. Qualitative. Hygiene. Of Business. Centralize. Simplify. Automate. All your tasks can be managed with one tool. Your organization's sustainability and performance. Automated processes are the foundation of safety and performance. BlueKanGo is the digital EHSQ platform to manage them. BlueKanGo is the digital EHSQ solution that has been trusted by over 3500 customers for 18 years. Digitize your Quality, EHS, and other processes. Quality and audits management. Employee safety and health. Environment. CMMS & inspection. Certification, Standards. Corporate Social Responsibility (CSR). Regulatory Watch. Strategic Planning. 6 key differences that make BlueKanGo different. BlueKanGo has been around for 18 years and is the SaaS platform with no boundaries. BlueKanGo is an innovative, scalable, and all-inclusive solution

The SBS Quality Database is a simple, inexpensive, ISO 9001 compliant software program that allows small businesses to efficiency manage the Quality Management System or QMS. The database tracks corrective actions, preventive actions (CAPA), internal audits, safety improvement, supplier corrective actions, continual improvement projects. Compile and analyze Customer Survey results. Identify and minimized risk using the risk management module (FMEA & SWOT analysis) . Document QMS review meetings and results. Document interested parties as part of the Context of the organization. Use the dashboard for a quick view of the overall performance. Cloud based or locally installed options are available. The program is ideal for small businesses striving for ISO 9001:2015, API Q1, AS9100, or TS16949 compliance. Free demo downloads are available from our website so you may try before your buy.

QAD EQMS (Enterprise Quality Management System) is a fully integrated enterprise quality management system that provides timely visibility into manufacturing and quality-related issues across the enterprise. It facilitates a preventative approach that helps to build quality into the process from the product design phase.

These workflows will help you create everything you need for a 510(k), and create quality records for 21 CFR Part 820 when you are ready to sell your device. Built-in tools for creating policies, procedures, or work instructions. With customized quality management reports, you can track non-conformances, deviations and CAPAs. Keep your team trained as you improve and scale your policies, workflows, and procedures. Automate validation testing for devices, apps, web and custom-made software. Reduce the time and resources required for lengthy testing, reporting, approvals, and other tasks. All your policies, procedures, artifacts can be converted into traditional documents for audit review.

iDoc is a document management system that is efficient. Automates and controls the documentation process, including distribution, organization policies and standard operating procedures. It is robust and secure in managing document management systems. It also provides real-time visibility. It streamlines all processes, including creation, review, approval, archival, and archival, and supports multiple files in controlled ways. Integration with training management system to assign training and to remove incorrect documents. This ensures accuracy for end-users and tracks compliance. Automated documentation, document retrieval with search/indexing capability, and document archive. You can easily set up labels, descriptions, and tags to help you organize information and keep track of documents. Keeps track of all documents and tracks any changes. This provides an audit trail that reports on documents and data fields.

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!

Unreported and uninspected information can be revealed. Unrivalled visibility and involvement can help you create safer, happier, more productive workplaces for your employees. Managers and frontline employees expect mobile-first, frictionless reporting, workflows, communication, and communications. A small number of people use most reporting systems, and they fail to include them. This results in a lack of or distorted situational awareness that can lead to unexpected surprises and insufficient or skewed situational awareness. It's not just the management teams that are aware of the pressing issues, and all the small observations that can impact your business and operations. They are eager to be heard, to participate, to solve problems and have an impact. Different reporting tools for different functions increase the ease of use for end-users. Falcony empowers your stakeholders and employees with a perfect companion that allows them to share everything they see, inspect, collaborate on, and resolve.

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.

Risk management integrator. Knowllence provides software, training and consulting services to help you manage QSE risk effectively. You can manage the safety of your employees (single file, arduousness, and chemical risk). Manage your robust design process (functional analyses, FMEA FMEA and FTA). You can manage the robustness and industrialization of your plant (AMDEC Process FMEA monitoring plan). Control the risks associated with ISO 14971 and design of medical devices. We can adapt our software to your requirements and follow your processes and standards. We can provide a complete service to assist you in your work sessions and risk studies. This will allow you to move your project forward while also making it sustainable. You keep control over the study and the plans for actions with efficient and simple-to-use software.

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

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.

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.

Quality Planning Studio FMEA software integrates core quality tools and ensures compliance to fundamental process flow steps. FMEA software is a single integrated software tool that can be used to plan, document, and monitor core quality requirements. It has been synonymous with continuous improvement programs for manufacturers around the world. The strong inter-relationship between Process Flows, FMEA and control plan, as well as SPC, is evident. FMEA ensures that products, processes and detection techniques are continuously improved. SPC results are continuously fed back to the engineers responsible for the FMEA process. Quality Planning Studio FMEA software stores all data in the QPS database. This ensures traceability and integrity across your plants' Process Flow/FMEA/Control Plan information. QPS can communicate with DataMetrics' SPC software (DataMetrics), which allows you to reduce redundancy, monitor characteristic capabilities, and more from the Control Plan.

Software for quality management. We offer QM solutions for all quality issues. This is what we have been doing for over 25 years. Our modular software BabtecQ is a complete solution to quality management. We are quality specialists. Babtec Qube is a cloud-based platform that allows you to connect with suppliers and customers to manage your quality tasks. Our products enable you to show the entire range of quality processes within and between companies. This is quality you will love sharing.

You can now focus on delivering safer and more effective products faster by eliminating repetitive, manual tasks. SmartSolve Postmarket Suveillance by IQVIA is a SaaS solution for postmarket surveillance. It provides best practices for centrally managing all postmarket surveillance activities. Fusion is a SmartSolve/RIM Smart user event. It provides in-depth education on timely and relevant quality topics and regulatory topics, as well as practical insights and tools that can be used within any Life Sciences organization. Fusion began as a live SmartSolve user event. It has expanded over the years to include both virtual and live events for SmartSolve and RIM Smart users. IQVIA SmartSolve™, Regulatory Connector, simplifies, automates, and integrates your compliance response times. Connected Intelligence, our innovative, interconnected approach to operational efficiency, is what we call Connected Intelligence.

DataLyzer Gage management software has been on the market for 40 years and is a complete webbased solution to calibrate gages and MSA research. It is fully integrated into our quality suite, which includes FMEA and SPC as well as OEE. It includes the following features: - Calibration of gages - Checking in and out of gages - Gage R&R and Kappa studies - Printing of calibration stickers.

We make the world safer, more sustainable, and more productive. Our software analyzes data from many sources to help companies make better strategic business decisions regarding mitigating risk. This is called Integrated Risk Management 4.0 (IRM 4.0). Our success is based on the fact that we have never had to deal with any of these incidents. Sphera's Environment, Health, Safety & Sustainability solutions provide end-to-end risk management on a single platform that can be scaled to meet companies' daily and strategic EHS&S goals. Sphera's Operational Risk Management Solutions help operators create a unified strategy to drive Operational Excellence throughout the enterprise. Sphera's Product Stewardship Solutions combine the best-of-breed and rich content to allow you to comply, streamline, and automate all aspects of your products' lifecycle.

CompliantPro Quality Management System Software ensures that a company's quality assurance needs are documented in one integrated system. This eliminates silos of information that can be managed as point solutions. CompliantPro allows organizations to manage their compliance and regulatory requirements beyond document control. The key areas are Environmental Health & Safety and Enterprise Risk Management, Training & Qualifications Audits, Customer / Supplier Management.

Virje complies to 21 CFR Part 11, 21 CFR Section 820, ISO 13485. Are you overwhelmed by the idea of Part 11 software validation Accessible wherever you are, whenever you work. Automated collaboration and automation can help you reduce paper, lower costs, and increase efficiency. This is the ideal solution for small- to medium-sized businesses. This system was designed specifically for quality control of medical devices. The system is flexible enough that it can adapt to your workflows without having to compromise. Modifiable change order approvals can be configured by employee role or by document type. Notifications to the responsible personnel at each stage of the change process. Ability to identify material dispositions for individual documents. Access to historical and released versions of documents is easy. Quick access to document history. Tracking of locations and distribution of hard copies. Notification of periodic document review.

You now have the option to be your own Quality Management Expert via an online platform. To facilitate smooth processes, templates can be integrated into your company. We offer complete Quality Management Systems as well as online solutions for ISO 13485 Medical Devices, and ISO 9001 General Quality Management.

Audit Manager is a software that supports quality management. It allows digital management of audits and quality controls in all phases: planning, compilation, and collection of evidence through checklists; verification and management for the entire nonconformity process; definition of corrective measures and data monitoring. You can access the calendar to schedule audits and add the relevant information (subject, checklists, lead auditor, coauditor or participants) for each one. Staff, both internal and outside, can be invited via email to consult the audit schedule prepared directly from the app. Once the inspection has been completed, you can generate the audit report as a PDF or Excel file and share it with the Company Management. You can add the archived minutes to the company's document repository.

The AssurX platform is a powerful software platform for enterprise quality management (EQMS) and regulatory compliance to reliably communicate and coordinate information, documentation, and activities. AssurX allows regulated businesses to quickly identify and control quality issues and risk exposure to avoid quality or noncompliance problems while improving workflow. AssurX QMS software is uniquely configurable to fit any established or dynamic business requirements. The system creates an electronic workflow of tasks, alerts, escalations, and approvals that can be automated to the desired level, mapping precisely to real-world operations. No other system is easier to deploy, configure, and modify. AssurX solutions integrate seamlessly to create a connected quality system. Solutions include audit management, corrective actions, training management, compliant management, document management, change control, risk management, EHS incident management, and more.

QEdge QMS is Enterprise Quality Management Software (EQMS). It optimizes quality and ensures regulatory compliance. Enterprise Quality Management Software (EQMS), reduces the risk for quality process failures, lowers overall costs, and makes organizational processes more compliant. QEdge is an EQMS that allows companies to manage their Quality Management System in a disciplinary regulatory environment. It brings together all quality processes, such as Change Control and Deviation, Investigation and Market Complaints. OOS, OOT and Risk Assessment. Document Control activities, Training Records, and Document Control activities. QEdge, an intuitive and configurable software platform, allows for cross-functional communication and collaboration. It can interface with legacy systems and facilitates error-free, cross functional communication.

Vault QMS ensures quality and compliance to GxP. Vault QMS integrates best practices and automates workflows to bring all parties - pharma, biotech companies, contract manufactures, and suppliers - into quality control processes for better visibility and control. You can easily bring departments, sites and suppliers, contract manufacturers, contract testing labs, or other partners into continuous quality improvement. Automated workflows and best practices will increase operational efficiency. Unified risk management can improve visibility across products and processes. A unified suite quality applications will improve speed, efficiency, compliance, and GxP. You can easily enable quality management processes by incorporating best practices for deviations, internal and external audits and complaints, as well as change control, CAPA and quality risk management.

SoftExpert EQM (enterprise quality management software) is the most comprehensive. It assists companies in achieving and maintaining ISO 9001 certification by automating highly interactive quality processes that are tailored to their specific products, operations, and business practices. As a modular and scalable solution platform, SoftExpert Quality Management Software seamlessly integrates all key quality initiatives, including process mapping, documented information (SOP - standard operating procedures, work instructions and records), non-conformance reports (NCR/NCMR), corrective/preventive actions (CAPA), quality indicators (KPIs). The solution can also manage supplier relations, customer complaints and quality audits, as well as competence and training, quality controls, quality inspection, and statistical process control, increasing QMS flexibility and robustness.

Paradigm 3 is both a web- and desktop-based platform that helps businesses manage compliance in document control, CAPA compliance, Competency Tracking, Training, and Document Control. The software includes tools such as an event manager to handle customer complaints and incident investigations, as well as tasks sent by e-mail and audit preparations. Paradigm 3 is beneficial to the following industries: Manufacturing, Test Labs, Healthcare, and Service Industries.

Vault QualityDocs provides automated workflows and audit trails that provide detailed audit trails. This reduces compliance risk and improves quality. It speeds up review and approval and facilitates the sharing SOPs and other GxP documents between employees and partners. Effective SOP management is made easier by automated workflows and visibility to the content status and processes. This reduces compliance risk. An intuitive, user-friendly interface is key to adoption and efficiency. Audit trails with detailed audit trails, content organization, powerful search, and robust search allow for better inspections and audits. You can securely access and use any web browser. If enabled, you can also print, distribute, track, and track the control of PDF copies. Pre-defined metadata and document taxonomy allow for operational harmonization. Organizations can quickly adopt best practices by using pre-defined pick lists for quality, manufacturing and validation documents.

HQMS applications, available on-premise or hosted, including Document Control, Audits, Corrective Action, Calibration, Training, Material Nonconformance, PPAP, Project Management, Risk Management and the HQMS Supplier Portal. Robust technical capability, including, configuration, personalization, and customization, with flexible and customizable security options, any HTML5 browser, Single Sign-On, and more. Integration with ERP and other apps. HQMS across several markets, including manufacturing (Aerospace and Defense, Automotive, Consumer Products, Medical Device, Food, Energy, and more), healthcare, retail, non-profits, and government.. Highly secure Document Control, Audits, Corrective Action, Calibration, Training, and the HQMS Supplier Portal with personalization, configuration, customization, and integration.

PLATO e1ns provides a central platform for product development. Transparent product development, a shared understanding of the system, and good, networked collaboration are the foundation for efficient, quick, and successful product development. PLATO e1ns allows for optimal product development (PDP) design. PLATO has created e1ns to help in the early stages. You have already laid the foundation for cost- and risk reduction. e1ns is a combination of methods and development phases within a system. The system model modeling (SysML), which covers all disciplines (mechanical, software and electrical, etc.) is one of its aspects. "Single Point of Information" is a central and direct access to all data and measures in the product development process via a web browser. We will create a custom methods framework, which is specifically tailored for your development process.