Alternatives to Paradigm 3

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.

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.

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.

ARMATURE Fabric™, allows you to manage all aspects of your accreditation, certifications, credentialing, audit quality, and compliance activities from one platform. Our software allows you to save time, work more efficiently and securely, and better serve your stakeholders. Whether you manage institutional, programmatic or specialized accreditation programs, certify individuals, products or organizations, conduct audits or assessments, or resolve non-conformances, ARMATURE Fabric can make it simpler and more efficient for both you and your stakeholders. Our cloud-based, secure software allows you to collect data in multiple methods (through online applications and audits, assessments and self-evaluations), manage your accreditation, certification, audit and compliance workflows, capture and manage documents and artifacts and identify and resolve issues; generate reports; and spot trends.

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

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.

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.

CSols AqcTools™ v2.6 allows users dynamically display Analytical Quality Control Charts (AQC) charts to monitor laboratory performance. It provides paper-free auditable investigations of control limit violations, comprehensive reports, and reduces time spent assessing and processing your QC data. AqcTools will be of benefit to customers in the water, environmental, and public health sectors as well as industrial laboratories that perform chemical, clinical, and microbiological analyses. AqcTools offers a variety of interactive, dynamic charts, ranging from the standard individual plotted AQC points to charts that can use both batch and daily data. To support ongoing analyst competency testing, users can also plot charts for individual analysts. You can view all information about each point, including date, batch number and analyst. All this information is just a mouse click away.

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.

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.

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.

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.

Integrate your Quality, Health, Safety & Environmental Management Systems in the Cloud or on a Mobile Application. Mango is used by many organizations. Our clients are located in the United Kingdom, Australia and New Zealand, as well as South Africa. You can be confident that we are able to manage your quality and information security with our ISO 9001 and ISO 27001 certifications.

In today's pharmaceutical manufacturing environment, it can be difficult to maintain consistent product quality and quality processes. To meet regulatory requirements, industries like the Pharmaceutical, Biotech and Life Sciences must maintain Good Manufacturing Practices (GMP). You must not only meet GMP requirements, but you must also be capable of proving it.

EzyPro Adaptive Management system QHSE (QHSE) enables you to seamlessly integrate compliance, performance and continuous improvement. EzyPro QHSE is a one-stop solution for compliance, maintenance and operational control. You can increase efficiency, share information, collaborate, and increase productivity. Flexible subscriptions are possible with its modular approach. EzyPro Healthcare – Hospital Quality Management System with integrated action tracking, dashboards and dashboards to meet requirements such as NABH or JCI. As a central hub for continuous improvement across the Healthcare unit, it was designed. Remote consultancy service is available for implementation support. QHSE Management System bundled comprehensive maintenance management solution. Increase equipment lifespan, increase time efficiency, and equipment uptime. This will result in lower costs and higher profits. You can easily manage work orders for repairs or maintenance, as well as transfer of assets, using a QR code assisted asset retrieval.

A digital quality ecosystem that delivers proactive quality. TrackWise Digital, a cloud-based, industry-leading quality management system, has integrated modules that support quality, compliance, and more efficient and effective decision-making. Users can use quality data to improve their culture of quality and increase company performance through advanced analytics and reporting across all quality processes. TrackWise Digital's Quality Process Accelerators, (QPAs), are based on Sparta’s 25+ years of expertise. They provide quick value and streamline digital quality. TrackWise Digital's QMS is the first to use AI to enhance quality-related decision-making capabilities. This allows for a shift in quality from reactive to proactive.

Momentum QMS is your guide in a world of uncertainty, complexity, ambiguity, and volatility. Momentum QMS is the best solution to your Quality, Safety, and Compliance needs. Momentum QMS's responsive design makes it easy to use from any device, for any function. Built-in reporting makes it easy to access the data you need, whenever and wherever you want. Momentum QMS is built on stable, reliable and widely-used Open Source software. Momentum QMS does not consume a lot of resources, and it leaves a very small footprint. No more silos. To increase enterprise-wide synergy, send and receive data from many sources. Multi-level authorization and role-based security allow you to keep your data and knowledge secure.

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.

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 Collaboration By Design (QCBD), a fully integrated quality management solution, is designed for manufacturing businesses. This Windows-based, affordable application makes it easier to achieve and maintain compliance with quality management standards like ISO 13485 and ISO 9001. CAMA Software's QCBD module offers a variety of modules for supplier management, training management, process deviations management, document control, equipment and more.

We all know that a system must be accessible in order to be used. You don't want pages to load and searches to take too long. You want to be able add records or find the information you need quickly, wherever and whenever you want. Wismatix QMS allows you to do exactly that. Wismatix QMS was built on years of experience in quality management systems implementation and auditing. It is known for its speed and reliability. Wismatix is committed to providing exceptional customer service. You will receive full support for the use and maintenance of your online quality management system. In the event that you do not require our system, we will send your data to your server to allow you to upload your data. Wismatix is committed to providing exceptional customer service. Wismatix will provide you with full support for the use and maintenance of your online quality management system. In the unlikely event that you do not require our system, we will send your data to you to upload to your own server.

Defect-free business processes are the key to quality products. CASQ-it was designed to cover all aspects of your quality assurance and management processes, starting with the development phase and continuing through the material processing - including your support processes. The key advantage of CASQ is its process-oriented operation. This functionality allows your CAQ system adapt to your processes, and not vice versa. CASQ-it supports quality assurance processes as they move into the future. Quality and reliability increase customer satisfaction while reducing the cost per unit. Each CASQ-it module can be used independently, allowing you to optimize your individual processes and workflows in your company from the beginning. You can combine our modules to create a complete quality assurance system.

Enterprise Quality Management Software in cloud for life sciences. Technology plays a crucial role in ensuring that QA is aware of any issues as they arise in today's complex operational environment. You can gain insight into your quality management system's performance and the current state in your operation to be more proactive and reduce risk. Montrium's Enterprise Quality Management system (EQMS), was designed to help life science companies tackle the content management challenges they face head-on. Each module of the SharePoint QMS can be used separately or as part of a fully integrated quality management platform. These modules can be used on-premise or in a cloud environment. These modules are ideal for pharmaceutical companies, contract manufacturers, and medical device companies. Built to comply with GMP/GCP requirements.

Ennov Quality Suite. A comprehensive QMS to increase efficiency and ensure compliance. Ennov Quality Suite Ennov Quality Suite combines the power of Ennov Doc and Ennov QMS with Ennov Report and Ennov Training to create an integrated quality management solution that improves operational efficiency and ensures compliance to industry standards like 21 CFR Part 11, GxP, and ISO. Ennov Quality offers a predefined inventory that includes quality documentation, processes, and workflows. These are based on industry standards and best practices. Ennov Quality customers can quickly get their system in production and begin to realize their return on investment. Ennov Quality, as all Ennov solutions, is easy to set up and requires no IT skills. A unified and intuitive content and information management platform that supports and enriches the entire Life Sciences product cycle. Our comprehensive QMS improves operational efficiency

Quality Link 7 is a combination of people and technology. It builds on our proven platform to help organizations automate processes, save time, and comply with regulatory requirements. Quality Link's document management system improves efficiency and eliminates the need for manual paperwork. This module will store and manage every document you create. This module allows you to print "uncontrolled" copies and perform other document-related tasks. You'll see a reduction in clerical tasks for quality staff by up to 90% with the improved organization. Our software converts existing documents from your previous management system and requires no learning curve. You won't have to lose your favorite applications as they can be easily integrated. Quality Link makes manual document maintenance obsolete and eliminates the need for constant monitoring.

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

Revolutionize your Life Sciences processes. You can dramatically improve the quality, control, and efficiency of your products and processes. Our fully compliant platform is pre-validated according GAMP5. This ensures inspection readiness at all time. You have complete control over all documents and processes. You can also customize workflows and automate when possible. You can enjoy uninterrupted workflows and full traceability with seamlessly connected and integrated modules. Our dedicated team is available to answer any questions you may have. Only the best Scilife experience is possible! Our Scilife platform automates, automates and organizes all processes in your industry space, no matter if you're in Medical Devices or Pharma & Biotech or ATMP. Click below to see which Scilife modules are available for your industry's unique lifecycle stages.

iPassport, a managed software service for healthcare labs, is designed to digitize, streamline, and improve the day-to-day management of quality and compliance. iPassport offers a complete suite quality management modules that allow you to keep track of everything, from document control to staff training. All your controlled documents are stored in one location with the appropriate access and edit rights and complete revision history. All the information you need to keep track of external and internal audits. Record and manage CAPAs, incidents and NCs. Manage staff training, competencies, tasks, and leave. A complete supplier database and an audit tool, including performance reviews. Manage and track stock and assets, including maintenance records.

QualityKick provides a QMS solution for the biological sciences. It is divided into different modules, each of which solves a particular part of the quality-management processes: document control and control of training, change control and control of events, CAPA and risk assessment, as well as audits and qualification of suppliers and equipment. It is a web application that can be accessed anywhere and on any mobile device. It works on all devices: computer, tablet, and smartphone. A guided tour is automatically loaded when new users sign in. You can edit documents in MS Word, and then send them to a configurable review process. You can configure different types of events, such as deviations or nonconformities. CAPA plans can be defined, actions recorded, and their effectiveness verified. Solutions for quality management within the pharmaceutical, biotechnology and medicine sectors.

A well-implemented Quality Management System (QMS) is essential for biotech firms to achieve regulatory compliance. It will also help them maintain product quality and safety. It will also help them manage risks effectively. It will drive operational efficiency. InstantGMP QMS was designed by quality and regulatory professionals for biotech companies. It is simple, affordable, and complete. It can be used by small-to mid-sized manufacturers in many different industries. This quality management software features guided workflows to reinforce adherence with government standards during the entire production process. It also has a variety of innovative features and specialized module. Maintain and improve the safety and quality of biotech products. Frameworks are provided for identifying, assessing and mitigating risk throughout the product's lifecycle to reduce the likelihood of quality incidents or product recalls.

Pharmaceutical and Biotech companies face challenges in meeting control documentation requirements in their day-to-day operations. Document management and control are essential components of any quality and compliance solution. Global Regulatory agencies expect all regulated companies to follow industry best practices during the manufacturing process. Phama Soft Sol created Document Management System software to help manage and distribute SOP's, STP's, and other regulated documents. Document management software systems can not only lower compliance costs but also improve product quality and process efficiency. Document Management System (softDMS) allows you to quickly retrieve the information you need, at the exact time you need it. This reduces the risk of miscommunications and errors which in turn minimizes risks, manhours, and other documentation errors.

Organizations need to standardize their business processes and automate them in order to bring new products to market quickly and comply with global regulations. QUMAS EQMS (formerly ProcessCompliance), a cloud-based solution that provides integrated regulatory, quality and compliance management capabilities within a validated QMS environment, is QUMAS EQMS. QUMAS's data-centric approach lets you manage quality content easily and access and re-use all data. This gives you a comprehensive view into Quality. Interactive quality dashboards from QUMAS provide QMS overviews across all business areas and quality initiatives. Export, email, and scheduling are all possible for reports. QUMAS allows QMS departments the ability to securely, efficiently, and compliantly exchange information in the cloud.

1factory's Manufacturing Quality software is cloud-based and on-premises and was specifically designed for manufacturing companies of any size. 1factory's Manufacturing Quality is a reliable and secure solution that allows for first article inspections and factory monitoring. It also provides quality control plans, in process and final inspections, inspection management, CAPAs and non-conformances. Other key features include the ability to calculate Process Performance (Ppt, Ppk), and Process Capability (Cpt, Cpk), variation/SPC control management, defect risk monitoring, and many more.

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.

ZenQMS improves the quality compliance profiles life sciences companies through a cloud-based platform. It is purpose-built to facilitate document collaboration, control, training, issues management, audits, and change management. ZenQMS is a team of technology and quality leaders who share the common goal of making quality management a business imperative.

ZipQuality, a software-enabled medical device service, helps companies bring new products to the market. Our collaboration platform allows agile teams to make rapid design changes while maintaining regulatory compliance. System (processes and tool) pre-configured; no need to change your quality system. The integrated system is able to handle rapid design iterations in product documentation. Your team will be guided by experienced consultants at every stage. Software tools that are fully featured, scalable, and built on the powerful ENOVIA platform. Our integrated system allows for rapid design changes, while keeping data and documentation in sync. All records are maintained in a audit-ready condition. Product requirements, Hardware requirements, Software requirements. We have a deep understanding of complex, software-intensive devices. ZipQuality is a structured documentation system that supports good systems engineering and efficient risk management. It also provides clear traceability.

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.

Document control made easy. You can create, review/approve and revise documents, as well as retire them. All transactions are recorded using e-signatures, timestamps, and stored in the Audit Trail. Audits from start-to-finish The SOLABS QM10 Audit APP allows you to track and document all aspects of your audits, from planning and preparation to closing. The SOLABS QM Essentials package offers advanced reporting capabilities and intuitive reporting. Trending and tracking are critical components of any quality management system. The dashboards and reports are easy-to-use, customizable, and can be shared in the most popular formats such as Excel, PowerPoint and PDF. You can share the reports and dashboards with anyone in your organization. In a matter of seconds, you can create, schedule, monitor, and assign training. Online assessments can be used to validate the learnings of your team. You can manage all aspects of training with the SOLABS QM Training section.

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.

We offer solutions to companies that have a high standard of quality. Our software solutions are characterized by a modern UX and useful functionality. They also feature high modularity and consistent compliance. Integrated solutions to manage quality and ensure quality. Focused on digitizing controlled documents and QA process. Solutions designed specifically to meet the requirements of the financial sector for written rules of procedure and management of policies. Cloud-based, prevalidated solution for automating your validation processes as well as digitally controlling and managing validation documents. Early setup of a digital quality management system with a solution that is tailored for startups and young businesses. Based on DHC VISION. It is ready to use, with immediate compliance. No license fees. Together, we digitize the quality management and quality control processes and ensure regulatory compliance.

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.

Small to medium-sized businesses (SMEs) will love the cloud-based Quality Management System software (QMS). TRACKMEDIUM, a monthly subscription service, includes modules such as Audit Management, CAPA and Document Control, Management of Change (NCM), Training Management, and Management of Nonconformance Management. TRACKMEDIUM allows companies to create safer products, increase efficiency, and comply with industry standards such as ISO 9001, 14001, and OSHA while lowering costs. The Audit Management software by TRACKMEDIUM streamlines audit-related tasks. This includes creating standard audit and checklist templates and generating audit plans. It also allows for the generation of audit recommendations and tracking CAPAs through closure.

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.

Clinevo OneQMS, a cloud-based system for quality management, allows organizations to manage compliance and quality processes digitally. Clinevo OneQMS provides an interactive platform for managing all quality and compliance processes within an organization. OneQMS allows organizations to manage documents and training, changes, CAPAs, and audits all in one place. It can be accessed using IE, Chrome and Firefox browsers. Dashboards and reports that are powerful and actionable for real-time monitoring of compliance and quality. Clinevo can be taught to business, quality, IT, and other teams within a few short hours. Clinevo OneQMS is compliant with all current and new regulations. It comes with a built-in training management system that allows the organization to manage its training processes efficiently. It is the best QMS and comes with transparent, optimized pricing.

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.

Arena PLM assists high-tech and medical device firms to quickly design, produce, or deliver innovative products. Arena allows everyone involved in new product development (NPD), and new product introductions (NPI), to collaborate more effectively and ensure regulatory compliance for FDA and ISO, ITAR and EAR.