DHC VISION Alternatives

For companies looking to accelerate development of their innovative medical device technologies, our Application Lifecycle Management and Quality Management Systems (eQMS) are easy-to-use, flexible, all-in-one software solutions designed to facilitate collaboration of employees on design control, and quality management to streamline medical device design. Innovate faster with a flexible item-based approach to documentation designed to control even the most complex SxMD (Software as/in a Medical Device) product design. Enhance quality management and ensure compliance with full traceability from design input to output with a purpose-built software platform that enables a collaborative quality culture across all teams. Ensure frictionless alignment between platforms with native integrations for Jira, GitLab, GitHub, Azure DevOps and more.

Perfect for a small company, TLM has everything you need, and can accelerate the implementation with consulting, training, procedure templates, and document writing/coaching support, plus we have validation templates and a system setting mode so small medical device companies have special features to help manage technical files and 510K submittals. TLM QMS Software saves you money AND makes your QMS more effective by providing a dual technology landscape for the two distinct QMS user types. Core modules include: • Audits • Contact Manager (CRM) • CAPA • Customer Feedback • Document Management • Electronic Forms • Employees • Employee Feedback • Equipment Calibration • Evaluations • FMEA • Inspections • Inventory/parts • Library • Meetings/Reviews • Metrics • Projects • Purchase Orders • Quality Record Mgt • Rejected Materials • Risk & Opportunities • Sales Orders • Strategic Planning • Surveys • Tasks/Events • Training • Work Orders

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

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.

Qualityze is a leading provider of enterprise quality management solutions, utilizing the Salesforce.com Technology Platform to build our EQMS Software solutions. Our team is 100% devoted to quality processes, compliance, and regulatory guidelines to address our customers' business environments. We do not distract ourselves with custom work or quality concerns. The idea of helping our customers create a culture of quality is not a new concept, but the way we developed our application, Quality Management Software, based on making it easy to use, intuitive, and inclusive. Therefore, the entire organization is involved in quality, not because they are told they should, but because it's easy, fun, and has a logical flow. We strive to optimize quality with excellence through our exclusive range of smarter quality management software solutions.

QT9's comprehensive cloud-based quality management software platform enables you to access real-time analytics in one unified suite. QT9 QMS makes it easy to automate ISO & FDA Compliance with 21 CFR Part 11 Electronic Approvals. Optimize processes for Document Control, CAPA's, Audits & More in one unified platform. Centralize records across multiple sites with ease. Never miss a deadline with automated email alerts/reminders. QT9 QMS makes quality management easy. Digitally transform Life Sciences, Biotechnology, Medical Device Manufacturers, Pharma, Aerospace and Food companies with user-friendly web portals for unlimited scalability. Get a free product tour! Start a Free Trial. Visit QT9qms.com

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.

Qualio is an all-in-one quality and compliance management platform built for small and growing businesses in life sciences and healthcare. Reliable, affordable, and easy to use, Qualio helps companies building life saving products get to market faster by reaching 100% ISO, GxP, and FDA compliance. With Qualio, companies can conveniently manage document control, training, CAPAs, NCRs, audits, suppliers, complaints, and more in one platform.

Bringing breakthrough products to market in highly regulated industries can feel like an endless series of trade-offs. MasterControl's software simplifies GxP workflows so you never have to sacrifice quality for cost or innovation for regulation. Complete and connected meets fast and flexible. From quality event management to document control and integrated training - MasterControl Quality Excellence transforms your quality data and processes into a competitive advantage. Modernizing your manufacturing operations starts with modern software. From work orders to work instructions and production records (EBR or eDHR) to logbooks, MasterControl Manufacturing Excellence is the simplest way to digitalize manufacturing.

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.

Pharmaceutical and Biotech companies are challenged to meet control documentation requirements in day-to-day operations. Effective document management and document control are critical parts to any quality and compliance solution. Global Regulatory agencies expect that all regulated companies follow current industry best practices throughout the manufacturing process. To meet these requirements Phama Soft Sol developed Document Management System software which helps to control and distribute the SOP’s , STP’s and other regulated documents. Document management software systems not only reduce the costs of compliance but also help you improve process and product quality. Document Management System(softDMS) able to retrieve the information you need exactly when you need it-minimizes the possibility of miscommunication and mistakes which in turn minimize risks, manhours and other documentation errors.

Greenlight Guru’s Medical Device Success Platform is the only all-in-one solution that helps you get your products to market faster, with less risk, and advance your success in-market. The platform helps companies manufacture safer products and get to market faster, simplifies regulatory compliance, and provides a single source of truth by connecting the management of all product development, regulatory, and quality processes from documentation and design controls to submission and ongoing compliance. Device makers across the globe are replacing reactive quality management tools and shifting their focus and efforts to ensure successful product launches and in-market success of innovative, life-changing devices.

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.

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.

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. At qmsWrapper, we cater to each industry’s unique quality management needs with tailored features: Compliance Made Easy: Adhere to standards like ISO 13485 and ISO 9001 effortlessly, maintaining a robust QMS. Risk Management: Simplify risk assessment with ISO 14971-compliant tools, effectively mitigating risks. Document Control: Intuitively manage documents for enhanced traceability and version control. Cloud-Based Accessibility: Access your QMS anytime, anywhere. Electronic QMS: Embrace efficiency with digitized QMS for faster approvals and real-time updates. Audit Management: Prepare for audits confidently with scheduling, tracking, and reporting tools.

Almond is a professional, cloud-based, quality management software for healthcare companies. The software enables computerized management of the quality processes in compliance with regulatory requirements. The system maintains a document audit trail, and full document indexing and ultimately achieves documented evidence of all QMS processes. Manage your suppliers seamlessly through the electronic organization of certificates and agreements; all information is concentrated in one place. Assign permission to your suppliers to perform training, required by your system at their premises, using your quality system. Receive automatic email notifications before supplier certification expires. An electronic control dashboard allows you to be updated at any time on the status of the project. Create as many logbooks as you need, with no budget considerations or storage restrictions. Automatic conversion to effective after training completion.

Inspired by people and technology, Quality Link 7 builds on our experience and proven platform for helping organizations automate processes, save money, and achieve regulatory compliance with an easy-to-use business operating solution. Quality Link delivers improved efficiency while eliminating manual paperwork with our document management. Every document you create will be stored and managed from within this module. You can print “uncontrolled” copies of your documentation from within this module, as well as perform many other document-related activities. With the enhanced organization, you’ll see clerical tasks by quality personnel reduced by up to 90 percent. Our software effortlessly converts existing documentation from your previous management system, and there’s no learning curve. But you won’t miss your favorite applications, as they can be easily integrated. With Quality Link, you can say good-bye to manual document maintenance, which requires constant monitoring.

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.

Providing automated workflows and comprehensive audit trails, Vault QualityDocs reduces compliance risk and improves quality processes. It accelerates review and approval processes and facilitates the sharing of SOPs and other GxP documents among employees and partners. Automated workflows and visibility into the content status and processes enable effective SOP management, reducing compliance risk. Intuitive, easy-to-use user interface drives adoption and efficiency. Detailed audit trails, content organization, and powerful search facilitate better audits and inspections. Securely access and use documents from any major web browser, or if enabled, print, distribute, and track controlled PDF copies. Predefined document taxonomy, metadata, and pick lists for quality, manufacturing, and validation documents facilitate operational harmonization and allow organizations to quickly adopt best practices.

Ideagen Quality Management is a modular SaaS solution designed with the needs of quality managers in mind. Trusted by more than 6,000 customers worldwide to digitalize their quality management processes and comply with industry standards. Ideagen Quality Management seamlessly integrates with your existing processes and acts as the backbone of your organization. With workflow automation and comprehensive document management, our system empowers your team to identify and rectify any issues before they arise. Elevate your organization's performance and gain a competitive edge with our powerful digital quality management solution. Our software allows you to gain complete organizational visibility, easily identify and act on risks, and make the most of opportunities. Unlock smart data-driven decision-making and secure world-class processes that satisfy your customers and regulators, grow your business, and secure new quality standards.

RQM+ is a global medical technology service provider focused on accelerating compliance and market success. Through our unparalleled expertise and industry knowledge, we deliver specialized solutions and expedite the journey along the full product lifecycle for medical technology companies, from concept to commercialization to post-market. Our portfolio of services enables the delivery of end-to-end solutions across the complete medical device product lifecycle. RQM+’s quality assurance engineers review material lists, set up suppliers, and support the design change process. RQM+’s design quality engineers help support packaging, sterility, biocompatibility, and device testing that may be needed. RQM+’s regulatory affairs consultants provide guidance and help with submissions to the FDA, notified bodies, or other government agencies. We use our extensive experience with the latest reimbursement requirements and value-based compensation models.

Quality Collaboration By Design (QCBD) is a fully integrated quality management software solution designed specifically for manufacturing businesses. This affordable, Windows-based application reduces the cost of achieving and/or maintaining compliance with quality management standards such as ISO 13485, ISO 9001, TS 16949, AS9100, and SQF 2000 / ISO 22000. QCBD by CAMA Software offers a host of modules for training management, supplier management, process deviations, document control, equipment management, and more.

Deliver products on time and on budget with Orcanos, an integrated software for ALM (Design Control) and quality management (QMS). An affordable cloud solution, Orcanos supports Requirements Management, Test Management, Document Control, Risk Management, and Quality Management procedures, on a single repository. Orcanos also features dashboards and real-time alerts, to help businesses keep track on their ongoing projects and gain real-time visibity on their progress. Orcanos e-DMS is an all-in-one document control software system that has been designed to allow end users to create, trace, search, archive and approve all documentation that is related to every stage of a medical device product launch. The e-DMS ensures that documents relating to the planning, design, development, manufacturing and service of a particular product can be quickly accessed, increasing the effectiveness of quality processes and reducing the time to market.

QualityKick is a QMS compliance solution in the cloud for quality management of the biological sciences. It consists of different modules; each of them solves a specific part of the quality management processes: document control, training, change control, events, CAPA, risk assessment, qualification, and audits of suppliers and equipment. As it is a web-based application, it can be accessed from anywhere and from any device mobile. Works everywhere: computer, smartphone, and tablet. Guided tour which loads automatically when new users log in for the first time. Allows you to edit documents with MS Word and send them through a configurable review and approval process. Different types of events can be configured such as deviations, nonconformities, or complaints. It is possible to define CAPA plans, record the actions, and verify their effectiveness. Solutions for quality management in the pharmacy, biotechnology, and medicine sectors.

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.

With LabWay-LIMS dedicate yourself to what you know how to do best and manage your laboratory. Integrated digital solutions for the organization and management of laboratory information. With the main objective of promoting productivity increases and process quality improvement, and oriented to any reality, LabWay-LIMS allows to computation of all areas of the laboratory. LabWay-LIMS is a highly competitive LIMS and QMS solution for different areas of activity. Proactive communication system and control of records of pending activities and processes. Integrated document management, quick and easy to use, providing verification and evaluation of orders and purchases. Management of internal and external audits for continuous improvement. Efficient team management, offering both profitability and speed. We align quality with management strategy. Management of immediate actions and effective resource management. Speed in sending results and improvement in service quality.

EQUMAS customizes digital solutions to our clients' operational needs.  Our unique, modular, multimodal technology helps manufacturing companies manage QMS, and also all operational elements in one. You could maintain separate systems for your quality control, inventory control, equipment management, and report compiling. Or you could use EQUMAS and take care of your entire workflow with a powerful, integrated, multimodal software package. Our system uses state-of-the-art AI components to make data-driven decisions, finding manufacturing deviations before even humans can. Every aspect of our system is integrated into the whole, allowing for real-time communication across the platform. This unique feature allows you to save time and energy coordinating multiple software systems to handle all of your data in one. Manage every employee with individualized roles and responsibilities. EQUMAS tracks and maintains specific individual information across the platform.

Reduce risk with ACE Essentials, the pre-validated Electronic Quality Management System (EQMS) software created for all highly regulated industries. ACE Essentials comes equipped with 10 workflows built in and all the necessary Standard Operating Procedures and Policies, resulting in a fully compliant quality management system from the beginning. Understand the risks associated with your assets with ACE Essentials features including a full audit trail tracking every single action in the system. Pre-Configured Workflows. Pre-Configured Event Management (Due Dates, Scheduling and Reminders). Pre-Configured Permission-Based Security. Full Documentation Pre-Configured. 50+ Documents. Multiple Site Capability. Free Upgrades Throughout the Life of the Product. Pre-Configured Tasks List. No Validation Time. Pre-Configured In-System Notifications. Pre-Configured Email Notifications

Revolutionize your Life Sciences processes. Drastically improve the control, efficiency, and quality of your processes and products. Ensure inspection readiness at all times through our fully compliant platform, pre-validated according to GAMP5. Maintain total control over processes and documents, customize workflows to perfection, and automate where possible. Enjoy uninterrupted workflows and full traceability through seamlessly connected and integrated modules. Our dedicated team is ready to answer your questions at any time. Only a first-class Scilife experience will do! Our Scilife platform streamlines automates and organizes every process in your industry space, whether you’re in Medical Devices, Pharma & Biotech, or ATMP. Click below to discover which Scilife modules support your unique industry lifecycle stages. Our software is equipped with all the advanced quality tools you would expect, and a bunch more that go above and beyond!

Enabling a digital quality ecosystem to deliver the promise of proactive quality. TrackWise Digital is an industry-leading, cloud-based quality management system with integrated modules that work together to support quality, compliance and more efficient and effective decision making. With reporting and advanced analytics across all quality processes, users can leverage quality data to strengthen their culture of quality and impact company-wide performance. Based on Sparta’s 25+ years of experience, TrackWise Digital’s Quality Process Accelerators (QPAs) provide rapid value and streamline end-to-end digital quality. TrackWise Digital is the industry’s first QMS to leverage AI for enhancing quality related decision-making capabilities, providing a shift from reactive to proactive quality.

ZenQMS enhances the quality compliance profiles of life sciences companies via a cloud-based platform, purpose-built to manage document collaboration and control, training, issues, change management, and audits with ease. The ZenQMS team is comprised of both technology and quality leaders with the shared mission of elevating quality management to be a business imperative.

uniPoint's Quality Management Software is a modular on-premise quality management software. Quality Management Software can integrate with other ERP systems with ease. Quality Management Software is suitable for manufacturers of any kind of product in any manufacturing mode. With Quality Management Software, users can manage processes such as document control, equipment management, non-conformances, corrective/prevantative actions, and more.

AlisQI is an easy to implement and integrate, flexible and cloud-based Quality Management platform. We enable manufacturing companies to make their Quality Management data-driven, automated and omnipresent. More than 70 factories worldwide use our platform for Quality Control, Quality Assurance and QESH management. We help our customers to reduce waste by up to 15%, increase their quality level and save up to 20% on time. We are proud to serve customers on all six continents, ranging from startup to Fortune500. We have yet to lose a customer. Our customers can be found in just about any manufacturing vertical: Chemicals, Personal Hygiene, Food & beverage, Automotive and Manufacturing.

By integrating your Quality, Health, Safety & Environmental Management systems in the Cloud and on a Mobile App. Organizations who rely on Mango for their QHSE compliance come in all different shapes and sizes. Our clients are located across United Kingdom, Australia, New Zealand and South Africa. Our certifications to both ISO 9001 and ISO 27001 gives you the assurance that we manage our quality and your information security. Supercharge your consulting company's growth by building a new recurring revenue stream and delivering more value to your clients. Mango sets you apart from your competitors. And because it's in the cloud, there’s no question that Mango is also the future of the industry. With Mango in your tool bag, you're able to give your clients an easier, more cost-effective way of tackling their compliance obligations. Mango is a popular Compliance Management solution developed by Mango Limited.

Clinevo OneQMS is a cloud-based quality management system that enables organizations to manage quality and compliance processes digitally. Clinevo OneQMS is an interactive platform to manage all quality and compliance processes of an organization. OneQMS enables organizations to manage documents, training, change, CAPA, and audits in one place. It can be accessed with basic internet/intranet using IE, Chrome, and Firefox browsers. Provides powerful and actionable dashboards and reports for real-time monitoring and tracking of quality and compliance. Business, quality, IT teams, and others can be trained on the Clinevo within a few hours. Clinevo OneQMS complies with all current and emerging regulations. It ships with an inbuilt training management system to efficiently manage the organization’s training processes. It is the best QMS software and comes with transparent optimized pricing.

Ennov Quality Suite. A comprehensive QMS to improve efficiency and ensure compliance. Ennov Quality Suite Ennov’s Quality suite combines the power and flexibility of Ennov Doc, Ennov QMS, Ennov Report and Ennov Training to create a quality management solution that not only improves operational efficiency but also ensures compliance with industry standards such as 21 CFR Part 11, GxP and ISO. Ennov Quality provides a predefined inventory of quality documentation, processes and workflows that are based on accepted industry standards and best demonstrated practices. This allows Ennov Quality customers to get their system into production quickly and start realizing their return on investment. Ennov Quality, like all Ennov solutions is very easy to configure and requires no IT skills. An intuitive and unified content and information management platform to support and enrich the entire Life Sciences product life cycle. Our comprehensive QMS improves operational efficiency

Overall, a well-implemented QMS is essential for biotech companies to achieve regulatory compliance, maintain product quality and safety, manage risks effectively, drive operational efficiency, foster innovation, and build trust with customers. InstantGMP QMS is a complete, simple, and affordable quality management system software designed by quality and regulatory experts for biotech companies. It can also apply to small-to-midsize manufacturers in a variety of industries. This quality management software has guided workflows that reinforce adherence to government standards throughout the entire production process with a diverse array of innovative features and specialized modules. Helps maintain and improve the quality and safety of biotech products. Provides frameworks for identifying, assessing, and mitigating risks throughout the product lifecycle, reducing the likelihood of quality incidents and product recalls.

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.

Unified Access to All Documents - Consolidates documents & processes in a unified document repository that can be used for Quality, Regulatory, R&D and more. - Metadata-based document model to adapt to your company’s organizational needs. - Configurable without any IT skills. - Scalable & secure: manage large volumes of documents. Improved Productivity and Efficiency - Intuitive user interface - Efficient search capabilities - User-centric design and connectivity to Microsoft Office 365 and Google Drive - PDF viewer to allow instant access to documents without MS Office or Acrobat - Versioning - Complete document cycle management Supports wide EDM needs - Quality, regulatory, cR&D, legal, commercial - CFR21 part 11 compliant - Document archival included - Seamless integration with Ennov Process (BPMS) & Dossier (eCTD publishing) - Advanced live reporting and dashboarding - Configurable without IT skills (including dashboards) - Suitable for regulated industries

Compliance software that drives operations. Improve safety and increase accuracy with the top mobile audit and inspection platform for teams trusted by Walmart, Wendy’s, and Fannie Mae. Upgrade your paper, Excel, and digital processes to the #1 field management platform for teams. FORM OpX combines advanced data collection and configurable workflows with powerful operational insights to boost compliance in real-time. Configure audits, inspections, and workflows to ensure teams consistently follow procedures and meet regulatory obligations. Capture data instantly with digital forms that guide teams to the right action. Configure automated alerts and escalations to trigger corrective action as soon as issues arise. Save time and money with customizable workflows that improve processes and increase compliance — everywhere.

At Opvia, we empower R&D, manufacturing and quality management teams to build custom process operating systems that streamline their workflows and give them a competitive edge. We work with fast-growing startups and enterprises across a range of industries, including biotech, pharma, food and beverages, engineering and medical devices, to help them digitize their processes and bring innovative products to market faster. With our powerful tools and expert support, we give companies the freedom to create and deliver like never before.

EzyPro Adaptive Management system (QHSE) is a powerful way to integrate compliance, performance, and continuous improvement. EzyPro QHSE, a one stop solution for compliance, maintenance, and operational control. Increase efficiency, share information, and collaborate. Its modular approach offers flexible subscriptions according to needs. EzyPro Healthcare - Hospital Quality Management system with integrated action tracking and dashboards for meeting requirements such as NABH and JCI. designed as a centralized hub for continuous improvement throughout the Healthcare unit. Option available for remote consultancy service for implementation support. Comprehensive maintenance management solution bundled for the first time with QHSE Management system. Extend equipment lifespans, improve time efficiency and equipment uptime resulting in reduced costs and increased profits. With a QR code assisted asset retrieval, easily manage work orders for repairs, maintenance or transfer of assets.

Quality management software. We manufacture and offer QM solutions for all quality tasks – as we have done for 25 years. As quality specialists, we have developed an all-round solution for quality management with our modular software BabtecQ. In addition, we offer Babtec Qube, a cloud-based platform with which you can interconnect with your suppliers and customers to edit your quality tasks. Our products allow you to depict the whole range of quality processes, both internal and across companies – for quality you will love to share. Would you like to refresh your knowledge about quality management? Then you have come to the right place! On our knowledge pages you can find out, for example, what complaint management or 8D report are all about. The System FMEA (also termed a system analysis) is a subsection of the FMEA (Failure Mode and Effects Analysis). It is intended to investigate an entire system and check whether all of the individual components within it work together correctly.

Teamcenter® software is a modern, adaptable product lifecycle management (PLM) system that connects people and processes, across functional silos, with a digital thread for innovation. The unmatched breadth and depth of the Teamcenter portfolio mean that you can solve more of the tough challenges required to develop highly successful products. From the easy, intuitive Teamcenter user interface, people across the organization can take part in the product development process more easily than ever before. No matter how you choose to deploy Teamcenter – whether it be on-premises, on-cloud, or SaaS delivered via Teamcenter X – you get the same proven solutions designed to help you innovate faster. Get started with Teamcenter by taking control of product data and processes, including 3D designs, electronics, embedded software, documentation, and your bill of materials (BOM). Reach greater returns on your PLM system by leveraging your product information across more domains and departments.

Defect-free business processes lead to defect-free products. And that is exactly why CASQ-it is designed to encompass all the steps in your quality assurance and quality management processes – starting with the development process, continuing through the material process – up to and including your support processes. The advantage of CASQ-it lies right here in this process-oriented mode of operation – functionality that enables your CAQ system to adapt flexibly to your processes – and not vice versa. CASQ-it supports your quality assurance processes on their journey into the future: Quality and reliability increase customer satisfaction whilst reducing the cost of quality. Each separate CASQ-it module functions independently – enabling you to optimize individual processes and workflows within your company right from day one. Our modules can be flexibly combined – or used to create a comprehensive quality assurance system.

Now you have the option of your own Quality Management Expert in the shape of an online platform. Templates ready to be integrated in your company to enable smooth processes. We offer complete Quality Management Systems and online solutions for ISO 13485 Medical Devices and ISO 9001 General Quality Management.

Maintaining consistent product quality and quality processes can be challenging in today’s pharmaceutical manufacturing environments. Regulated industries such as the Pharmaceutical, Biotech and Life Sciences are required to maintain Good Manufacturing Practices (GMP) to meet regulatory requirements. Not only do you need to meet GMP requirements you must also be able to prove this. Using paper-based forms, disconnected systems, or manual processes to manage, track and report on quality issues and actions does not provide effective solutions for implementing harmonized, integrated quality management processes, which follow industry best practices.

Document control made simple, document lifecycles, create, review/approve, revise, and retire documents. All transactions are recorded with e-signatures and timestamps and stored in the Audit Trail. Audits from start to finish. From audit planning to audit preparation and all the way to audit closure, track and document your internal and external audits with the SOLABS QM10 Audit APP. Intuitive reporting because trending and tracking are so critical to any quality management system, the SOLABS QM Essentials package includes advanced reporting capabilities. The reports and dashboards are available in formats that are easy to use, customizable and share the most common formats, whether it be Excel, PowerPoint, PDF, etc. with anyone within your organization. Create, assign, schedule and monitor training in a few clicks. Leverage online assessments to validate your team’s learnings. The SOLABS QM Training section allows you to handle all aspects of training.

Virje complies with the requirements of 21 CFR Part 11, 21 CFR Part 820, and ISO 13485. Overwhelmed by the thought of Part 11 software validation? Accessible from wherever you are, for whenever you work. Eliminate paper, reduce cost, and increase efficiency with automation and centralized collaboration. Perfect for small to medium-sized businesses. Built from the ground up specifically for medical device quality management. A system that is flexible enough to adjust to your workflows and processes, without having to compromise. Configurable change order approvals by employee role and by document type. Notifications to responsible personnel at every stage in the change process. Ability to designate material dispositions for individual documents. Easy access to released and historical versions of documents. Quick viewing of document change history. Tracking of where-used locations and distributed hard copies. Periodic document review notification.

Experiment with new methods for managing your projects and data. Small, medium, or large structures, Laby adapts perfectly to your organization and your areas of expertise. Join our community of users and let’s develop tomorrow’s innovations together. Organize your projects, experimental plans, and essays. Develop a recipe for the manufacturing of finished products. Automate item management and traceability. Supervise laboratory instruments and manage their maintenance. Laby allows the centralization of all your files on a single platform for easy access and retrieval. Prepare and validate quality documents before distribution. Search, share, and consult all scientific papers. Sign reports based on 21 CFR part 11 and EIDAS standards. Track time spent by project, and export data. Complete management system allowing a high standard of monitoring. Receive training in order to get to work quickly and save time every day.