CloudEQMS Alternatives

QVscribe, QRA's flagship product, unifies stakeholders by ensuring clear, concise artifacts. It automatically evaluates requirements, identifies risks, and guides engineers to address them. QVscribe simplifies artifact management by eliminating errors and verifying compliance with quality and industry standards. QVscribe Features: Glossary Integration: QVscribe now adds a fourth dimension by ensuring consistency across teams using different authoring tools. Term definitions appear alongside Quality Alerts, Warnings, and EARS Conformance checks within the project context. Customizable Configurations: Tailor QVscribe to meet specific verification needs for requirements, including business and system documents. This flexibility helps identify issues early before estimates or development progress. Integrated Guidance: QVscribe offers real-time recommendations during the editing process, helping authors effortlessly correct problem requirements and improve their quality.

isoTracker Quality Management is a popular cloud-based quality management software (QMS) that is used by small to medium sized businesses on a worldwide basis. It helps to manage ISO 9001, ISO 13485, ISO 22000, ISO/IEC 17025, ISO 14001, ISO 45001, ISO/TS 16949, ISO 14971 systems...plus many other systems. It also conforms to the requirements of 21 CFR Part 11. It is a flexible and modular product with modules in document control, audit management, non-conformance management, customer complaints management, risk management, training management and CAPA management. It can be configured to meet an organization's specific needs and provides free training and free support. It has been independently judged to provide the best customer support in its category.

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. Artintech ERP includes a wide range of modules designed to optimize business operations. Key modules include Procurement, Warehousing, CRM, Distribution, Quality Management (QMS), Workplace Safety, Document Control, Non-Conformance and Corrective and Preventive Actions (CAPA), Inspection, and Computerized Maintenance Management System (CMMS).

Dot Compliance provides the industry’s first off-the-shelf QMS solution – ready to deploy from day one, with little to no setup required, while also incorporating industry best practices and standards that address the latest global regulatory requirements. Powered by the Salesforce.com platform, our solutions enable life science organizations to quickly digitize their quality and compliance processes including Document Management, Training Management, Change Control, CAPA, Customer Complaints. Compliant with 21 CFR part 11, EU-Annex 11 and support ISO 9001, 13485, 14971, 27001 & MORE! Processes included: ▶ Document Management ▶ Training Management ▶ Quality Event Management ▶ CAPA Management ▶ Change Management ▶ Complaint Management ▶ Audit Management ▶ Supplier Quality Management ▶ Risk Management ▶ Design Control ▶ Deviations/Non-conformances ✔ Seamless Install ✔ Cost Effective ✔ One-Stop-Shop

Lucidity is a full-featured EHS Management Solution with dedicated software modules to create a perfectly tailored solution for your business needs. Connecting employees at all levels of your business around a single source of cloud-based HSEQ truth on a SaaS platform they will want to use. An integrated, streamlined, cloud-based HSEQ software solution is crucial for maintaining the records required to meet and maintain your ISO requirements. Lucidity has been designed with ISO 9001, 14001 & 45001 in mind. Helping you track and monitor the data and processes you need to succeed. One of the biggest challenges safety teams face is getting a real-time view of what is happening on the ground. Lucidity has been designed to provide easy access to the organization's single source of safety truth. Whether in head office, behind a computer, or on-site on the Lucidity App, capturing and analysing safety data is as easy as the click of a button.

SimplerQMS offers a cloud-based Quality Management Software that is fully validated according to GAMP5 and specifically designed for the Life Science industry. This comprehensive QMS platform 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, ICH Q10, and others. The software offers a wide range of Life Science QMS modules, such as Document Control, Change Management, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, Quality KPIs, among others, ensuring a seamless experience. SimplerQMS enhances document handling by allowing users to work directly in Microsoft Office applications like Word, PowerPoint, and Excel.

The SBS Quality Management Software Suite (QMS Suite) is a group of 5 software modules that work together for efficient Quality compliance. The QMS Suite can be deployed on your local server or accessed from our cloud server. Each module is designed for ease-of-use to reduce training overhead and improve overall compliance. Password controlled access and privileges ensure you may control access to critical features for each user. The SBS QMS Suite of modules: SBS Quality Database - CAPA / 8D with root cause analysis - Nonconformance management - Risk analysis (FMEA, SWOT, risk register) - Audit management SBS Ground Control - Employee training management (LMS) - Document control SBS Asset Tracking Database - Calibrated equipment - Preventive maintenance SBS Inspection Database - Data collection / SPC - Control Plans SBS Vendor Management - Approved vendor list / AVL - Supplier qualification plans Great product for efficient and affordable QMS Compliance.

BPAQuality365 is a prebuilt QMS software to use in your secured Microsoft 365 cloud, leveraging tools used by collaborators daily, with no need to change user habits. It’s modern, compliant with any device, flexible to match your unique needs, and powered by innovative M365 technologies. The app includes powerful compliance document management, audit, non-conformance, CAPA action, risk, equipment, health, safety, environment modules compliant with ISO 9001, FDA Part 11 and medical regulations. The QMS app is closely integrated to discussion flows in Teams and enable instant quality improvement. Go a step further and reach your Quality 4.0 objectives by combining powerful AI features, best-in-class workflow automation, business intelligence and mobile Power Apps to run on any device. Benefit from BPA’s Microsoft Preferred status to configure your QMS to your needs, transfer knowledge to your power users and get trained on M365 technologies.

With ARMATURE Fabric™ you can manage your accreditation, certification, credentialing, audit, quality, and compliance activities within a single platform. Our software enables you to save time, operate more effectively and securely, and better serve your stakeholder communities. Whether you are managing institutional, programmatic, or specialized accreditation programs; certifying individuals, products, or organizations; conducting audits or assessments; or resolving non-conformances or other issues, ARMATURE Fabric can make it easier and more efficient for you and your stakeholders. Our secure, cloud-based software allows you to collect data in multiple ways (through online applications, audits, assessments, self-evaluations, inspections, forms, and surveys); manage your accreditation, certification, audit, and compliance workflows; capture and manage documents and artifacts, identify and remediate issues; generate reports; and spot new trends.

Xybion LIMS (formerly Labwise XD) is an all-inclusive LIMS, ELN, QMS, and DMS. Xybion LIMS drives lab workflows, instills consistency, improves data quality, and supports regulatory compliance with a complete laboratory management solution that connects with your operating systems with powerful laboratory information management and analytics. Xybion LIMS creates optimized workflows for the unique business needs of all regulated laboratories including research, diagnostics, quality control, stability studies, and more.

Intellect QMS is the latest version of Intellect's flagship product designed to help organizations and quality leaders meet FDA, ISO, and other global GxP regulatory compliance requirements. Intellect offers faster implementation time, robust out-of-the-box QMS capabilities, and extreme configurability to modify or build new apps. Empower your onsite and remote workforce with virtual auditing, online approvals, 21 CFR Part 11 electronic signatures, and ensure your team can access only approved and up-to-date quality documents, data, reports and analytics anytime, on any device. Intellect’s Environmental, health, safety and quality (EHSQ) software acts as a data management system for capturing, storing, and analyzing information related to occupational health and safety, waste management, and sustainability. It aims at reducing operational risk and improving health while attaining sustainability goals.

integrum is a user-friendly, flexible, yet comprehensive, integrated management system for Governance, Risk & Compliance, Safety, Health, Environment, Quality Management System. Assisting over 1.5 million users from businesses of all sizes across the globe to streamline processes, reduce risks and accelerate business growth. integrum offers off the shelf business processes, that can be used as-is, modified or processes can be configured to your specific requirements. Drag and Drop functionality allows for quick and simple configuration of any business process. Supported by mobile apps (Apple and Android) that allow the flexibility for any business process to be completed in the field in real-time. Then, we use all of the data your team is generating and provide real-time business intelligence reports that provide insights into what is happening in the business. Allowing the business to make fast, data-driven decisions, and providing governance over the business.

Drive exceptional quality and process performance with a platform that puts you in cruise control. Crush poor quality, safety concerns and redundant processes with the all-in-one E-Data Now!® Audit and Quality Inspection platform, that includes the tools you need to connect your team performance, simplify checklists, root cause non-conformance, improve processes and grow customer satisfaction. E-Data Now! is a leading manufacturing, construction and site safety/compliance no-code, cloud-based platform, that digitizes quality inspection and process audits, automates workflows and provides mobile data-driven insights. The obvious benefit – clearing out your paperwork, cleans up the clutter in your audit processes and identifies unknown audit redundancies. The simple answer – a custom form creation and mobile data collection platform with digital tools made for the trades: to train, record, capture, react, correct, schedule, comply and build better processes.

A web-based quality system software suite that helps medical device companies automate their processes and simplify regulatory compliance. Modules include: Audit Management, CAPA, Complaint Handling, Design Control, Document Control, Equipment Management, Nonconforming Materials Reporting, Supplier Management and Training Management. Designed from the beginning for ISO 13485 and 21 CFR Part 11 compliance. Audit results are recorded for each requirement in the audit. Requirements are marked as conforming, nonconforming, or not applicable. Each result may be detailed with one or more findings. Findings that may be recorded include observations, major nonconformances, and/or minor nonconformances. Findings may result in Corrective and Preventive Actions (CAPA) and/or may be documents with audit actions already completed.

Cloud-based Quality Management System (QMS) software that is ideal for small to medium businesses (SMEs). TRACKMEDIUM is a monthly-based subscription service with modules including Audit Management, CAPA, Document Control, Management of Change, Nonconformance Management (NCM), and Training Management. TRACKMEDIUM enables companies to create better and safer products, improve efficiency, and achieve compliance with industry standards including ISO 9001, 14001 & OSHA while lowering costs and risks. TRACKMEDIUM's Audit Management software streamlines audit-related tasks which include creating standardized audit and checklist templates, generating an audit plan, conducting audits, identifying nonconformances and recommendations, tracking CAPAs through closure and reporting results.

Every organizational structure is unique, requiring a custom tailored approach when dealing with concerns related to international standards. More often than not, this is a time intensive process. To address these needs, ISMS Solutions offers Conformance Works, a proprietary platform that walks customers through an automated system assisting customers with becoming compliant with whatever ISO standard they need. Simply put, Conformance Works simplifies and customizes the standard certification approach for each organization. With a built in document management system, global change editor, compliance management system, and risk assessment module, company documentation becomes straight-forward and efficient. The software will be accessible via multiple digital methods. Allows faster implementation of ISO standards for certification. Provides a streamlined user experience to meeting or exceeding ISO standards.

Document Control is a document management service whose purpose is to support controlled processes and practices for creating, reviewing, correcting, issuance, and distributing of documents. ISO standard-based QMS QISS Offers CAPA Management Software System for Automating Corrective Action Processes in Regulatory Environments. Adopt your own risk-based thinking. Centralize to prevent and mitigate your risks. Standardized workflow helps you stay in control of changes in your organization. Build a paperless document management system with numerous additional benefits. Develop a culture of continuous improvement with the visibility of each non-conformance.

The Secure Audit, Risk, Compliance & Quality Software. With On-Premise and Cloud-based deployment options. Auditrunner offers granular encryption and role-based access control for audit files and documents at-rest. All data transfers are protected. We have automated 3000+ business processes for enterprises around the world. Our GRC platform modules are just a few of them. Cloud-based or On-Premise, deploy and start using. Hassle-free integration process enables you to enjoy the benefits of the platform within weeks of kickoff . The low-code platform we are built upon is fully customizable and allows for compliance with any standard or regulation. Operate in a responsive manner in today’s fast-moving, ever-changing regulatory environment and comply with multitude of different legislation instantly without the need for assistance. The ease of use we offer is unmatched.

ZipQuality is a software-enabled service that assists medical device companies in bringing new products to market. Our collaboration platform manages rapid design changes for agile teams while ensuring regulatory compliance. Pre-configured system(processes and tools); no need to alter your quality system. The integrated system easily handles rapid design iterations for product documentation. Experienced consultants guide your team at every step. Fully-featured, scalable software tools built on the proven, powerful ENOVIA platform. Our integrated system enables rapid design changes while keeping product documentation and data in sync and maintaining all the records in an audit-ready state. Product requirements, hardware requirements, software requirements. We understand complex, software-intensive medical devices. The ZipQuality system is based on a structured documentation framework that supports good systems engineering, efficient risk management, and clear traceability.

QSE SMART is a quality, safety, environmental and risk management software application developed especially for small to medium-size business organizations and projects of 5 to 500 users. QSE SMART provides a solid framework that complies with key requirements of ISO9001, 45001 and 14001, and simplifies the day-to-day running of your integrated QSE management system. QSE SMART makes ISO make sense in your business. Designed around a risk-based approach according to ISO 31000, QSE SMART helps you to capture and exploit the key information and metrics that support your business objectives in respect to quality, safety, environmental and business risk management including your objectives and targets, management reviews, risks and opportunities, non-conformances and improvements, audits and inspections, accidents, incidents and hazards, corrective actions, equipment calibration and control of documented information.

While others fear risk, we embrace it. With offices in Los Angeles, London and Sydney, Protecht redefines the way people think about risk management. We help companies increase performance and achieve strategic objectives through better understanding, monitoring and management of risk. Protecht provides a complete solution comprised of world-class risk management, compliance, training and advisory services to businesses that need to manage non-financial risks and regulatory compliance, as well as regulators and governments around the world. With our flagship Protecht ERM no-code SaaS platform you can dynamically manage all enterprise risks in a single place: - Risk Assessment, RCSA, and risk registers - Compliance management - Incident management - Internal audit - Dashboard summaries of Key Risk Indicators (KRIs), Key Control Indicators (KCIs), and Key Performance Indicators (KPIs) - For ERM, vendor (TPRM & VRM), cyber & IT, model & AI, operational resilience & BCM

One platform for governance, risk management, and compliance. RISMA's GRC platform gives you and your colleagues the overview you need and helps you manage and document your compliance, risk management, and ongoing control work. You are guided through the process and everyone involved only needs to have knowledge of one system, thereby increasing efficiency. Regardless of the industry, there are regulations and standards that you must comply with and document your compliance. For many, it is a comprehensive project. Legislations are complex, and there exist many complex requirements, making it difficult to gain support from the rest of the organization. Compliance will, therefore, not be straightforward. However, RISMA's solution can help you make it simple, so you only need to focus on, exactly, what you are good at.

Compliance Management Software for the Cannabis Industry. Optimized Cannabis Compliance Software. ​The medical cannabis industry is highly regulated. Most states require cultivators, processors, and distributors to keep track of every seed, ounce of flower, and edible they sell or discard for quality issues. To stay on the right side of the law in the cannabis market, you need to have a paper trail for all transactions from the cultivation to the final sale. ​Constant shifts in an ever-evolving medical marijuana marketplace, coupled with the need to ensure compliance and reduce risk can no longer be managed with traditional software or manual templates alone. Features You Need to Succeed. ​Otter Systems Compliance Management Software provides a centralized platform for tracking regulatory requirements, organizing compliance documentation, and managing compliance processes, with features including: Cannabis Document Control, Policy Management, Change Management, Supply Chain Control.

The AssurX platform is a versatile enterprise quality management system (EQMS) and regulatory compliance management platform. AssurX allows enterprises of any size or complexity to create a system that reliably communicates and coordinates quality and compliance information, documentation, and activities across the enterprise. AssurX allows regulated businesses to quickly identify and control risk exposure and avoid quality or noncompliance problems while improving workflow. AssurX QMS software is highly 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. Begin with just the solutions and functionality you need now, then implement what you like whenever you’re ready. No other system is easier to deploy, configure, and modify.

1factory's Manufacturing Quality is a cloud-based and on-premises quality control software solution specifically created for manufacturing companies of all types and sizes. Powerful, reliable, and secure Manufacturing Quality by 1factory provides first article inspections, factory monitoring, quality control plans, in-process and final inspections, incoming inspections, inspection management, CAPAs, non-conformances, and more. Additional key features include running metrics calculations for Process Performance (Pp, Ppk), Process Capability (Cp, Cpk), variation / SPC control management, defect-risk monitoring, and more.

Food Safety Software enabling cost-effective transformation of food safety, NPD, customer complaints and supply chain transparency. Save time and complete consistent, auditable risk assessments of products & suppliers; our food safety software includes horizon scanning and VACCP/TACCP. Be audit-ready 24/7 and never receive an audit non-conformance, guaranteed. Transform specification management for raw materials, and finished products and answer product queries instantly. Automate supplier quality monitoring or internal non-conformance management with automated workflows to ensure prompt closure of non-conformances. Let our team manage the entire complaints process using market-leading software to save time, money and improve customer service. Deliver new product launches faster, better, together while ensuring that all safety, quality, legality and profitability requirements are met.

SoftExpert EQM is the most comprehensive enterprise quality management software (EQMS). It helps companies to achieve and maintain ISO 9001 certification through automated, highly interactive quality processes tailored to an organization’s 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 also manages supplier relations, customer complaints, quality audits, competence and training, quality risks and controls, quality inspection and statistical process control, increasing QMS agility and robustness.

Workflows designed to help you create everything needed for 510(k) submission and create quality records needed for 21 CFR Part 820 once you're ready to start selling your device. Built in tools to draft policies, procedures, and work instructions. Ability to track non-conformance, deviations, and CAPAs with customized quality management reports. As you scale and improve your workflows, policies and procedures, keep your team trained automatically. Automate validation testing on devices, apps, web, and custom off the shelf software for your enterprise. Reduce time and resources needed for lengthy testing, reporting, and approvals. Generate all your policies, procedures, and artifacts into traditional documents for audit review.

QEdge QMS for Enterprise Quality Management Software (EQMS) system that optimizes the quality of various processes and ensures regulatory compliance. Enterprise Quality Management Software (EQMS) system reduces the risk of quality process failures; lowering overall costs and making the organizational processes more compliant. QEdge, as an EQMS accommodates companies in a disciplinary regulatory environment to make Quality Management System more robust and well managed by bringing all the quality processes such as Change Control, Deviation, Investigation, CAPA, Market Complaints, OOS, OOT, Risk Assessment, Document Control activities, Training Records and many more on a single platform. QEdge is an intuitive and highly configurable software platform to manage various regulatory, and nonregulatory business processes that facilitates error-free, cross-functional communication and collaboration with Quality management as a base and can interface with the legacy systems.

Monitoring Performance. Recording Results. Contact us to get access to a demo account, or to set up your organization. Download 80/20 Quality from the Apple App Store, Google Play, or use our web app. Customize the dropdown menus to meet your needs. Inspectors on the floor can document a non-conformance directly in the 80/20 Quality App with enough detail and pictures to illustrate the issue for the decision-makers in your business. Management receives an alert that an issue has been identified and can make a decision on what steps manufacturing should take to fix, scrap or return a non-conformance. The inspector is alerted through the app with explicit instructions on how to move forward. The inspector takes the approved action and documents its completion. All activities are logged for data capture and analytics to look for trends and find improvement opportunities.

Managing risk and complying with healthcare regulations is hard enough. Add in pressure to contain costs and do more with fewer resources, and the tasks become even more formidable. Historically, healthcare organizations considered digital compliance solutions as an optional tool in their larger compliance program. Even today, some health systems lack a full-time compliance team or rely on manual processes and disconnected solutions to manage and report on compliance issues. This invites a greater margin for error, provides little or no visibility enterprise-wide, and strains resources. Navigating compliance using manual processes without a healthcare-specific solution increases your odds of being out of compliance. Health systems that lack proper governance and continue to use multiple, siloed systems or processes face operational inefficiencies, compliance risks, fines, and more.

The Intact Platform is the leading cloud and on-premise Enterprise Resource Planning (ERP) solution for audits, assessments, certification, accreditation, and standards worldwide. It goes beyond other audit collection tools on the market with a full solution approach that helps you manage communications, business goals, and personnel. The Intact Platform is unsurpassed in functionality and features a fully modular end-to-end workflow that is easily scalable. ✓ 34% increase in efficiency on average (up to 60+%) ✓ Unmatched modularity, flexibility, and scalability ✓ All standards and audit services ✓ Digital workflow – no paper ✓ On-site and remote auditing ✓ Non-conformities & corrective actions ✓ Risk-based auditing & planning ✓ Easy client communication ✓ Reporting & business intelligence (BI) ✓ Central data and management hub (incl. full audit trail) ✓ Nonstop innovation

Streamline processes and manage associated risks with the most integrated suite of Health & Safety software solutions. With ProcessMAP, companies establish consistency and provides realtime insights to improve your Health & Safety performance and ROI. Streamline, standardize, and track processes essential to various regulations and compliance frameworks. Built-in alerts, robust CAPA management, and advanced reporting capabilities increase accountability, provide visibility across the organization, and keep you ready for audits and inspections. Reduce risk through the correlation of safety and claims experience data. Identify and mitigate unsafe activities and associated risk by analyzing the root cause of events and claims. Our platform helps reduce risk by stopping claims before they happen. Manage sustainability performance and metrics reporting with the industry's leading cloud platform. Streamline collection, verification, and analysis of company-wide KPIs.

iCompliance is a comprehensive digital platform designed to streamline Quality, Health, Safety, and Environment (QHSE) management, Environmental, Social, and Governance (ESG) initiatives, and Governance, Risk, and Compliance (GRC) processes for organizations across various industries. Our software offers tools for incident reporting, risk assessments, audit management, corrective actions, and more to ensure compliance with regulations and standards, promote safety and environmental responsibility, track ESG performance, engage stakeholders, and manage regulatory requirements, internal controls, and risk mitigation strategies. With customizable workflows, real-time analytics, integration options, mobile accessibility, and multilingual support, iCompliance empowers organizations to achieve operational excellence, mitigate risks, and drive sustainable growth.

AuditComply is a Belfast-headquartered Enterprise Risk Management Platform. Developing & providing comprehensive solutions for Risk, Quality, Compliance & EHS. A SaaS-based solution to spot hazards/issues, monitor risk, tackle uncertainty and boost performance. The company operates in highly regulated industries such as Automotive, Food & Beverage, Oil & Gas, Aviation and Manufacturing. With key clients situated throughout the UK, EU, US, Middle East and Asia Pacific regions. AuditComply has combined the comprehensive enterprise workflow with the speed and ability to deploy a mobile-first app. Enterprise customers select us because we deliver value on day one. We embrace change seamlessly to meet their daily needs, promote visibility, reduce costs and drive operational efficiencies whilst anticipating and managing enterprise risk. Deliver engaging reports with dynamic risk scoring, summaries, control matrices & more.

Paradigm 3 is a web and desktop-based platform designed to aid businesses in compliance management in regards to Document Control, CAPA Compliance, and Competency Tracking and Training. The software offers tools such as an event manager for incident investigations and customer complaints, tasks delivered by e-mail, audit preparations, among others. Some of the industries that benefit from Paradigm 3 are Healthcare, Manufacturing, Test Labs, and Service Industries. With Paradigm 3 it is no longer necessary to buy endless add on modules to manage all your compliance needs. Our system is made up of 4 modules with over 50 standard forms to meet all of your requirements for Quality, Safety and Environmental and by utilizing our form designer you can create new forms or redesign the ones supplied to ensure they exactly meet your needs.

Retailers, wholesalers, and suppliers have to work together to ensure product safety and shelf availability for their customers. Our solutions reduce out-of-stocks, improve product safety and expedite sourcing. Discover local and hot new products, request samples, vet for compliance requirements and seamlessly on-board. Reduce financial, brand and regulatory risk with the industry choice for compliance and risk management. Reduce out-of-stocks, grow revenue, cut operational expense, and create supply chain visibility. The ReposiTrak is the most scalable, proven, end-to-end B2B commerce and compliance management solution available. Connect with an expert.

CompliantPro Quality Management System Software is a tool that ensures a company’s quality assurance requirements are documented in a single, integrated system which demolishes silos of information managed as point solutions. CompliantPro allows an organization to manage its compliance and regulatory requirements beyond just document control. Key areas include Environmental Health & Safety, Enterprise Risk Management, Training & Qualifications, Audits, and customer / supplier management.

Managing a stability study is a complex process and mistakes can occur. Using a manual paper based system increases the risk of errors. The only solution is to implement a software based process that automates your stability studies and shelf-life analysis. Stability studies are highly scrutinized by regulatory agencies. Companies must be able to prove the validity of their data. Automated solutions provide the ability to produce the necessary documentation in real-time to satisfy auditors. Systems like Nova-Stability helps companies maintain regulatory compliance while reducing risk to the patient. Nova-Stability is a powerful process based feature-rich system that manages the entire stability testing process. This comprehensive solution is compliant with current regulatory guidelines on a global level. Nova- Stability accommodates all types of stability studies.

With Food Portal, you can easily comply with auditable scheme requirements, in a way that’s effortless and actually makes your job easier. Your food business can operate incredibly robust integrated quality systems for a fraction of the operational costs associated with dated offline methods. Excellent systems make your life easier, and your food safer. Compliance requirements are becoming more demanding all the time. Food Portal is here to support food manufacturers by providing the solutions you need. The systems on Food Portal automate away repetitive and time-consuming jobs, so you can focus your attention where it's needed. This isn't just a compliance solution, the systems on Food Portal actually serve to make quality processes quicker and less demanding.

To bring new products to market as quickly as possible in compliance with global regulations, organizations need to standardize and automate their business processes that manage the collection, tracking and analysis of information and the resolution of related issues. QUMAS EQMS (formerly ProcessCompliance) is a cloud-based solution for Enterprise Quality and Process Management that delivers comprehensive integrated regulatory, quality and compliance management capabilities in a validated QMS environment. QUMAS’s data-centric approach allows you to flexibly manage quality content and to access and re-use all quality data, providing comprehensive visibility into Quality. QUMAS’s interactive quality dashboards provide QMS overview across business areas and quality initiatives. Reports are available for export, email and scheduling. QUMAS allows QMS departments to exchange information securely, efficiently and compliantly in the cloud.

Ultimately records of all risk management activities must be kept and they need to be readily available for inspection. Most healthcare leaders know that their accreditation both legally and morally compels them to implement risk management. Yet, most have not as this was loosely enforced. The Omni-Assistant is a sophisticated modular enterprise system. It is highly intuitive, fully integrated, streamlined and optimized to support best business practices with full quality compliance to regulatory bodies. The Omni-Assistant Core is the predominant module that bridges and successfully connects all the modules. Enabling seamless integration, the processes are activated from one module to another based on specific business rules. The robust workflow engine design efficiently initiates processes and formulates triggers and events based on your business needs.

A Compliance and risk management system can help ensure a robust and sustainable business, give you a decisive edge in the marketplace, and is a requirement for many contracts. In the current economic climate, it's more important than ever for your system to be Faster, Better, and Smarter. At Qudos, we are passionate about helping you do just that. Our IMS software, online resource library, internal auditor training, and professional consultancy services have helped hundreds of organizations to develop their management systems, achieve certification, and maintain compliance. Call or email now to discuss your compliance and risk management system needs. Qudos has the software and expertise that will help you implement and maintain your compliance and risk management system faster, better and smarter.

QIMAone enables global brands, retailers and manufacturers in consumer good industries to digitize their quality and compliance operations, collaborate with key partners across their entire supply chain and collect reliable data to minimize disruption, increase visibility, and drive continuous improvement. Digitize your quality management, connect to your supply network and collaborate with suppliers to prevent defects. Onboard suppliers and inspectors, assign inspections and follow corrective actions collaboratively. Import, create custom workflows and checklists for inspections and audits. Consolidated actionable KPIs and benchmark to boost your supply chain. Visualise your supply chain and leverage risk-based strategies to drive proactive improvement programs. Reduce costs and save time to focus on value-added activities using standardized processes and automation. Empower your vendors and factories with actionable insights, e-learning content and collaborative tools.

Enterprise Quality Management Software in the cloud for the life sciences. In today’s complex operational environment, technology plays a vital role in ensuring that QA is made aware of the issues as they happen. Gaining insight into the performance of your quality management system and the current state of your operation helps you to be more proactive, which minimizes risk and eliminates costly delays. Montrium has designed its Enterprise Quality Management system (EQMS) to enable life science companies to tackle the quality challenges that they face in content management head-on. All of our SharePoint QMS modules can be used independently or together as a fully integrated quality management system. These modules are available as part of our Montrium Connect Platform and can be deployed on-premise or in the cloud. Perfect for pharmaceutical companies, contract manufacturing organizations, medical device companies. Built to achieve compliance with GMP and GCP requirements.

HSI is the leading Environmental Health & Safety (EHS) platform for workplace health, safety, training and compliance solutions. EHS is a series of unified safety applications that handle core day-to-day responsibilities across your organization, improving command, increasing safety engagement, and streamlining productivity. HSI has been designed to suit all industry types and businesses of all sizes. Our combination of technology and content solutions help Safety, HR and Operations leaders train and develop their workforce, keep workers safe and meet regulatory and operational requirements. HSI connects your system from workers in the field to the executive team in the boardroom with fast and easy to access, enter and report EHS data in real-time.

Proven solutions to operationalize your pandemic response plans, systematically monitor, and report on the health status of your employees and visitors, and assist your business’ return to productivity. Improve your safety culture by engaging employees, enhancing workflows, and increasing data visibility across all levels of your organization. Cority helps you break down departmental silos, improve reporting, and achieve operational excellence. Cority's unified compliance management solution is designed to help you take the guesswork out of compliance. myCority connects your frontline employees no matter where they are with the tools they need to mitigate risk and drive compliance. EHSQ experts design, implement and support the Cority solution. That’s why we are the leader in Occupational Health, Industrial Hygiene, and Employee Health solutions. Take your safety programs to the next level by proactively mitigating risks, managing compliance, and reducing incidents.

For life sciences manufacturers, it is quality or nothing. A streamlined quality process that ensures quick business decisions, regulatory compliance, and the highest product quality requires a robust system. Assure-IQ is designed to deliver. When combined with Caliber’s Document Management and Training and Learning Management systems, organizations can enjoy an unmatched quality experience with Assure-IQ. Assure-IQ is designed to streamline the complete quality assurance system. With 30+ modules to pick from, build a platform that suits you. Along with quality processes, document management and training management can be seamlessly integrated to manage the complete product lifecycle. The on-cloud and on-premise solutions are built on the latest technology to match the changing needs of the industry. A flexible QMS that blends into your company’s systems can help you set your own benchmark for quality success.

OpenText™ ALM Quality Center serves as the single pane of glass for software quality management. It helps you govern application lifecycle management activities and implement rigorous, auditable lifecycle processes. Leverage the reusability, traceability, and automation of ALM tools to improve efficiency in developing, testing, and maintaining applications. Automate result collection and gain real-time visibility into application quality, eliminating time-consuming and error-prone human processes. Enforce standard process with built-in ALM workflows and templates. Ensure compliance with detailed change tracking and a risk-based approach. Build an automated, vendor-neutral ecosystem for data consolidation across your application lifecycle with out-of-the-box integrations and APIs. Meet your scalability, security, and application architecture requirements with the deployment option of your choice – on-premises, cloud, or SaaS.

Zeva provides a highly intuitive interface and utilizes Microsoft’s Azure Cloud to provide a robust and secure hosted environment to scale from small organizations with fewer than 10 users to global enterprises with over 10,000 employees. What makes ZEVA a value proposition, for any organization, is the ability to create and manage an unlimited number of custom assessments, while providing real time data and analytics to decision makers and management anywhere in the world. Mitigate risk and maintain compliance with centralized secure hosting, improved reporting, and real-time dashboards and analytics. Items identified with “Findings” can be immediately assigned corrective measures to ensure timely remediations. The CodeLynx team developed the ZEVA platform to support the evolving evaluation requirements of commercial and government organizations of any size.