Best Medical Quality Management Systems of 2024

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.

Carizma QM, a web-based software, supports users in managing all aspects of regulated documents, from authoring, review and approval, release, and archiving. Management and creation of regulated documents, e.g. SOPs. Integrated workflows that can be reviewed and approved. After approval, automatic start of training workflow. Read and understood. Electronic signature - 21 CFR Part 11 compliant. Display of users who have understood and read. Audit trail and validation. CarizmaQM supports users in managing the entire lifecycle of regulated documents. Key information is defined by the author, e.g. document type (SOP or work instruction, form, checklist etc. Document title, process owner (department), document type, review cycle, and title. When a document is to be reviewed, users are identified by e-mail. Carizma creates a skeleton document.

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.

SpineNEXTGEN, an ERP solution that is GST compliant for pharma companies, is the only step. SpineNEXTGEN ERP software is the best choice for pharmaceutical companies. It offers a wide range of cutting-edge features including cost, sales and purchase management. For a long time, there has been a shortage of an ERP system that is competitive in the pharmaceutical industry. SpineNEXTGEN offers a solution to this problem, offering the best pharma ERP software for companies that want to manage all aspects their business from one place. SpineNEXTGEN is the best ERP software to manage manufacturing and management in the pharmaceutical industry.

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.

The VLMS from ValGenesis is packed with features and functions that will significantly improve traditional validation processes. Our system offers a complete view of the validation process, integrated validation lifecycle management functionality, as well as integration with existing systems. Paperless validation software automates workflows, compliance requirements can be instantiated in automated processes, electronic signatures can be performed via instantaneous routing and automatic notifications. Dashboards, metrics, and reporting are available immediately. Audits and inspections require minimal effort to fulfill requests. As it pertains to requirements management and testing methodology, consistency is achieved.

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.

DataMetrics is able to provide all product manufacturers with the real-time SPC data and analytics that they require to evaluate current processes and develop a proactive approach to meet or exceed production goals, maintain or improve product quality, reduce scrap and rework costs, comply with industry standards and OEM requirements. The genius interface that connects to your entire manufacturing floor allows for universal data collection from manual, semi-automated and automated data acquisition. This allows you to collect all of your quality data in one central repository or database, and then report on it. Data silos can be eliminated by consolidating data from hundreds gages, sensors and CMM, as well as PLCs. DataMetrics, which is compliant with OPC UA, offers a solution that is backed by strict access control and advanced security.

BIOVIA solutions provide a unique scientific management environment that enables science-based organizations to create and connect biological and chemical innovations that will improve our lives. The BIOVIA portfolio, which is a leader in the industry, focuses on integrating science, experimental processes, and information requirements from all aspects of research, development, quality control, and manufacturing. Capabilities in the areas of Scientific Informatics and Molecular Modeling/Simulation Data Science, Laboratory Informatics Formulation Design, BioPharma Quality & Compliance, Manufacturing Analytics, and Laboratory Informatics. BIOVIA is committed in accelerating innovation, improving productivity, quality and compliance, reducing cost, and accelerating product development for customers across multiple industries. Connect scientific innovation processes and information throughout the product lifecycle.

The Ennov platform has its own workflow engine, which provides advanced capabilities. Ennov Training, Ennov eTMF, and Ennov RIM use workflows. They enable the organization to control the sequence of tasks and data modification, while also providing visibility throughout the organization. Functional administrators can configure workflows using a graphical interface. To ensure consistency, coherence checks are performed when you save modifications. Ennov ensures that workflows are consistent and reliable. Each Ennov workflow comes with a configurable form. Dynamic sections allow data entry to be made easier by displaying or hiding fields depending on what field values have been entered (e.g., the type of Incident). The connected user can enter free text, select values from picklists, and add additional files as needed. To complete a workflow step, an electronic signature may be required.

InSilicoTrials.com, a web-based platform that allows users to create and simulate computational models and simulations. There are many easy-to-use tools in silico. The platform is primarily for users in the medical device and pharmaceutical industries. In silico tools for medical devices allow computational testing in different biomedical areas such as radiology, orthopedics, and cardiovascular during product development, validation, and design. The platform offers access to in-silico tools for the pharmaceutical industry, which can be used at all stages of drug discovery and development. It also covers a variety of therapeutic areas. The only cloud-platform built on crowdscience makes it easy to access validated models and reduce your R&D expenses. There is a growing list of models that can be used on a pay-per-use basis.

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.

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

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.

You expect fast, accurate, and conclusive results when using LC-MS/MS in research or routine workflows. SCIEX software helps you get the most from your high-performance LC/MS/MS system. It provides specific workflow and application modules that can be used to complement your operating system. Your mass spectrometer will run with the right software combination that suits your needs. These are the core engines for SCIEX nominal mass systems and accurate mass LC/MS/MS systems. These modules are designed to quickly and reliably acquire, process, and report data, while remaining compliant. Add-on modules allow for simplified workflows and high performance. With application-specific software modules, you can convert your data into conclusive results faster.

Loftware Prisym 360 offers innovative content management features that incorporate industry best practices. It is specifically designed to meet the complex regulatory requirements for clinical supplies labeling. Many clinical labeling teams use English MLT/CLT variants for defining the content of booklets and labels for clinical trials. The number of countries in each study increases and each country has specific regulatory content, phrases, and language requirements. Therefore, the manual process of designing booklets and printing them takes longer and is more risky. Prisym 360's CLT/MLT solution prompts users to provide study information. Then, it automatically generates MLT, CLT, and booklet designs based on its knowledge about content and design requirements. This reduces the time it takes to create a clinical label or booklet, reduces errors and ensures compliance with regulatory requirements.

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.

Ideagen Quality Management, a modular SaaS application, is designed with quality managers in mind. More than 6,000 customers trust Ideagen Quality Management to digitalize and comply with industry standards. Ideagen Quality Management integrates seamlessly with your existing processes, and is the backbone of your business. Our system's workflow automation and comprehensive documentation management empowers your team by identifying and resolving any issues before they occur. Our powerful digital quality management software will help you to improve your organization's performance, and give you a competitive advantage. Our software helps you gain full visibility of your organization, identify risks and take action, and maximize opportunities. Secure world-class processes and smart data-driven decisions that will satisfy your customers, regulators, and grow your business.

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.

LabWay LIMS allows you to focus on what you do best, and manage your lab. Integrated digital solutions to organize and manage laboratory information. LabWay LIMS is a LIMS and QMS solution that allows for the computation of all laboratory areas. Its main goal is to promote productivity and process quality improvements. LabWay is a highly-competitive LIMS and QMS for different areas of activities. Proactive communication system, control of records for pending activities and process. Quick and easy-to-use integrated document management that provides verification and evaluation of purchases and orders. Management of internal and outside audits to ensure continuous improvement. Team management that is both efficient and fast. We align management strategy with quality. Management of immediate action and effective resource management. Improved service quality and speed in sending results.

Almond is a cloud-based professional quality management software designed for healthcare companies. The software allows for computerized management of quality processes that are in compliance with regulatory requirements. The system maintains an audit trail of documents, indexes all documents and provides documented evidence for all QMS processes. All information is centralized in a single place. This allows you to manage your suppliers easily. You can give your suppliers permission to conduct training at their premises using your quality system, if it is required by your system. Receive automatic emails before the expiration of supplier certification. You can be informed at any time about the status of your project using an electronic control dashboard. You can create as many logbooks you need without any budget or storage restrictions. Automatic conversion from ineffective to effective after training completion.

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.

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.

RQM+, a global service provider for medical technology, is focused on accelerating market success and compliance. We deliver specialized solutions to medical technology companies and accelerate the journey along the entire product lifecycle, from concept through commercialization and post-market. Our portfolio of services allows us to deliver end-to-end products and solutions throughout the entire medical device lifecycle. RQM+ quality assurance engineers review materials lists, establish suppliers, and support design change processes. RQM+’s design quality engineers support any packaging, sterility or biocompatibility testing that may be required. RQM+ regulatory affairs consultants offer guidance and assistance with submissions to FDA, notified authorities, or other government agencies. Our extensive experience with the most recent reimbursement requirements and value based compensation models is what we use.