Veeva Vault QualityDocs Alternatives

Interfacing’s Digital Twin Organization software provides transparency and Governance to improve Quality, Efficiency, and ensure Regulatory Compliance. Map, analyze, and automate processes, manage regulatory compliance, assess risks within a single platform! Interfacing’s digital twin solution (Enterprise Process Center - EPC) is an enterprise management system that helps companies digitalize processes to streamline operations, increase productivity, and continuously improve. Interfacing’s digital business platform – Rapid Application Development (RAD) Tools, with its Low-Code Development methodology will optimize usage of your technical resources and maximize transparency for ongoing improvement. Discover how our Low-Code Rapid Application Development module provides all the tools to create and deploy Custom, Scalable, Secure, and Mobile ready Applications in Days vs. Months!

Complete EHSQ solution designed for manufacturing, utility and government organizations that allows plant managers to track, analyze and report on their EHSQ processes. Our solution automates workflows, centralizes data and simplifies collaboration. TenForce offers various integrated modules to help streamline processes such as Audits, Incident Management, Lockout/Tagout (LOTO), Permit to Work, Management of Change, and Shift Management. It offers mobile capabilities, which allow field workers and inspectors to access the software on mobile devices. Its built-in data analytics and reporting functionality enables managers to gain insights into the processes and risks of their industrial plants or public infrastructure assets. This visibility helps them address environmental, health, safety, quality, and compliance issues. TenForce helps manufacturers optimize their established processes while minimizing incidents.

ACE is a quality management software solution for companies of any size, in any stage, in any highly regulated industry. ACE is fully configurable allowing your company to adapt ACE to fit into your exact quality needs. Empower all levels of your organization with intuitive user interfaces, easily search for all your documents and records, and transform your data into actionable intelligence with advanced analytics all on a single platform. Our one-stop software includes: -Office 365 Integration -Inspection Management -Document Management -Risk Management -Product Lifecycle Management -Learning Management -Audit Management -Quality Events -Paperless Validation -Electronic Signatures (21 CFR Part 11 Compliant) -Endless Workflow Configurations -And so much more! ACE comes with everything you need, all included at one price. Every application is included, no more a la carte pricing. No more nickel and diming. One software, endless solutions.

LogicalDOC helps organizations around the world gain complete control over document management. Focusing on business process automation and fast content retrieval, this premier document management system (DMS) allows teams to create, collaborate, and manage large volumes of documents and stores valuable company data in a centralized repository. System features include a drag-and-drop document upload, forms management, optical character recognition (OCR), duplicate detection, barcode recognition, event logging, document archiving, integrated document workflow, and so much more. Schedule a free, no obligation, one-on-one demo today.

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.

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.

MediaLab’s Document Control is a powerful way to manage your laboratory’s policies, procedures, and documentation. Our twenty years of expertise in clinical laboratories have created a document control solution that guides you to full compliance with all laboratory standards, regulations, and best practices. Document Control provides an automated, centralized platform for all of your document approvals, workflows, edits, sign-offs, audits, and more—with flexibility and customization features to match your laboratory’s unique needs. MediaLab's Document Control supports: • Digital records and version control of all documents, • Standardization across all documents from all sites, • Electronic signatures that meet 21 CFR Part 11 standards, • Customized approval workflows and processes, • Robust searching to easily locate specific documents, and more!

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

Fastest growing Enterprise Quality, Health and Safety Management System (QHSE) natively built and run on the Salesforce platform. Unified QHSE solutions, which combine EQMS and EHS, help our customers of all sizes deliver quality products and services in the safest, most sustainable way by mitigating risk, problems, and inefficiencies while protecting customers, employees, suppliers and brand. Every organization – irrespective of its industry, geography or size – involves an interaction of activities and processes with the environment. These activities may have an adverse or favorable impact on the environment depending on the type of activity being carried out. Our Environment Management solution has been designed to minimize and mitigate these adverse impacts on environment, to such an extent that our already depleting biodiversity is protected, and nurture an ecosystem where all living organisms coexist sustainably.

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.

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.

Qualtrax is a complete quality and compliance software system used to manage and control documentation, automate key business processes with customizable workflows, streamline training management, manage internal and external audits and ensure critical industry regulations are addressed in real-time. Qualtrax is an invaluable resource in heavily-regulated industries, where complying with standards including ISO 17025, 17020, 13485, and 9001, TNI, GFSI, FDA, and FQS is required.

MasterControl Quality Excellence solutions are used by five of the largest regulatory agencies in the United States. A leading software-as-a-service (SaaS) provider, MasterControl helps companies get their life-improving products to market sooner. It does this by providing cloud-based solutions that manage an organizations documents, training and exams, corrective/preventive action, validation, and more. And its not just quality MasterControl has solutions for the entire product lifecycle.

Ensure quality and GxP compliance with Vault QMS. With built-in best practices and automated workflows, Vault QMS brings all parties – pharma and biotech companies, contract manufacturers, and suppliers – into quality processes for better control and visibility. Easily bring departments, sites, suppliers, contract manufacturers, contract test labs, and other partners into continuous quality improvement processes. Increase operational efficiency with automated workflows and built-in best practices. Improve risk visibility across products and processes with a unified approach to risk management. Improve speed, efficiency, and GxP compliance with a unified suite of quality applications. Readily enable quality management processes with built-in best practices for deviation, internal and external audits, complaints, lab investigations, change control, CAPA, and quality risk management.

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.

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.

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

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.

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

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.

ValGenesis's VLMS is chock-full of features and functions that are designed to significantly improve traditional validation processes. Our system provides a holistic view of the entire validation process, comprehensive validation lifecycle management functionality, and the ability to integrate with existing systems. With paperless validation software, workflows are automated, compliance requirements are instantiated in automated processes, and electronic signatures are performed via instantaneous routing along with automatic notifications. Metrics, dashboards, and reporting are immediately available. Requests during audits and inspections are fulfilled with minimal effort. Standards are implemented and consistency is therefore attained as it pertains to requirements management, testing methodology, and risk management.

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.

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!

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.

iDoc offers an effective document management system. Controls, and automates the documentation process like distribution, organization policies, standard operating procedures, work instructions, and so forth. It is very robust and secure in controlling document management systems and provides real-time visibility. Streamlines all the processes from creation, review, approval, and archival of critical documents and supports multiple files in a controlled manner. Integration with training management system for assignment of training and also to eliminate wrong documents which ensures accuracy to end-users and track compliance. Simplified automated documentation process, document Retrieval with Searching/Indexing capability, and document archival. Easily set up tags, labels, and descriptions that help sort information & keep track of documents. Records and maintains all documents and every change made to records provides audit trail reporting of documents or data fields.

Qualis document management system ensures secure documentation with controlled distribution to end-users. It provides workflow-based document approval with revision control. End users have the latest approved version of any document reducing the risk of obsolete documentation. The activity workflow can be configured with Roles as per needs. Multiple workflows can be configured to associate with the respective document type. Reduce paper and storage space, secured storage and recovery. Distribution of approved documentation, reduced risk of obsolete copies. Improved regulatory compliance, controlled access with ease of search. All metadata is stored in a central database. Database agnostic (supports MS SQL, Oracle, Postgre SQL). Overall organization-level document management and controlled distribution solution. Qualis DMS is a single platform for integrated document management and control.

Adept Software gives you fast, centralized access to your most important documents in a secure, collaborative environment that saves your business time, reduces risk, and lowers operating costs. Align your company on a common platform—a single source of truth that delivers a unified view of engineering and business content. Empower stakeholders located anywhere to quickly find the right document—regardless of where it’s stored—and improve productivity by 20 to 30%. Avoid expensive mistakes and safety issues by ensuring your workforce always finds the correct version. Improve efficiency and eliminate bottlenecks by ensuring documents automatically follow predefined approval processes. Notifications and time-based alerts keep everything on track. Design reviews and multi-site collaboration are easy with everyone on one platform. Vaults can be replicated so documents are available to everyone locally, and Adept keeps everything in sync.

Digitize your processes. Security. Environment. Quality. Hygiene. Of Business. Centralize. Simplify. Automate. One tool to manage everything. For a sustainable performance of your organization. The performance and safety of an organization is based on automated processes. BlueKanGo is the digital EHSQ solution to manage them. Whether you are looking to address societal and environmental issues, minimize your risks, improve your operational excellence, rely on the solution approved by more than 3500 customers for more than 18 years. Digitize your Quality, EHS and more processes. Quality & audits management. Health and Safety of employees. Environment. CMMS & inspection. Certification, Standards. Corporate Social Responsibility (CSR). Regulatory Watch. Strategic Planning. 6 differences that are our key strength. With more than 18 years of existence, BlueKanGo is the SaaS platform that has no limits but your imagination. An innovative, scalable and all-inclusive solution

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.

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.

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.

IMSXpress ISO 9001 is a document control and quality system management software. The IMSXpress client application can be installed directly on user computers, or on a Windows server and then be distributed to users by remote desktop services as a remote application. The database is an MS SQL database. It can be installed on any MS SQL Server 2014 or higher and be accessed by the IMSXpress application over any type of network. You can set up your own remote access, use our cloud-based data hosting service, or get the online subscription package. Fully automated training system with self-training, integrated document training, job descriptions, and more. Use for document, engineering, and process changes. Make fillable PDF form templates, fill the forms with data, and create records. Use for scheduling and administrating maintenance, and for managing spare parts inventory. Manage complaints, non-conformities, risk management, audit findings, and more.

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.

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.

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.

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.

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.

FutureVault is an industry-leader in secure document exchange and Digital Vault solutions for financial services and wealth management organizations, changing the paradigm of document and information management with the Personal Life Management Vault™ and Business Life Management Vault™. FutureVault’s multi-tiered platform is transforming enterprise, advisor, and client value propositions by significantly improving the way documents, data, and information are managed within a secure, audit-ready, single source of truth. By powering firms with FutureVault’s white-labeled platform and mobile applications help firms meet books and records compliance, improve data privacy, drive front and back-office efficiency with automation and open APIs, and deliver an enhanced digital client experience to better engage with households and the next generation. Data extraction and AI-driven patterns to gain additional efficiency and insight are available for enterprise customers.

Automate and digitize process workflows within firms through document generation from customizable templates. Maintain templates with dynamic content, and standardize data fields across documents. Templates, building workflows, process standardization and cross-business data standardization. Eliminate the need to maintain hundreds of document types across varying product categories. Build business workflows across document types with searchable and indexed metadata. DigiDocs is well-integrated with DigiSign, allowing you to generate a standard document, pre-fill it with relevant data, and get it digitally or electronically signed by multiple parties.

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.

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.

Artificial intelligence impacts your business’s most significant metrics by facilitating better business decision-making, increasing revenue generation, and improving the customer experience. OrNsoft’s artificial intelligence software has a demonstrated track record of helping our clients to achieve optimal levels of performance. CEErtia is cutting-edge software powered by artificial intelligence and cognitive technologies for intelligent process automation. Manual labor is expensive, CEErtia can reduce your costs and allow you to accomplish more. Go faster with CEErtia’s artificial intelligence processing, and greatly reduce your workload. Automatically recognize and avoid errors, duplicates & fraud to ensure the compliance of your files. No need to be in the same room to handle and verify documents, everything is accessible online. Our software can quickly verify and validate your data, no matter where it comes from.

Organizations are challenged to stay abreast and ahead of digital transformation. They need solutions that inject intelligence into their workflows, including their document control and print management work streams, so that they drive business outcomes, cut costs and impact the bottom line. Kofax Output Manager helps organizations by delivering the most intelligent governance for your document control and print management needs. Its superior security features help organizations improve document security, minimize inefficiencies and mitigate compliance risks. Kofax Output Manager’s best-in-class print and document control capabilities infuse process orchestration, including intelligent redaction, and keen re-routing to increase workforce capacity. Kofax Output Manager helps protect printed documents and prevents the unauthorized flow of sensitive information.

Document Management, Workflow, PDF Editing and Web Portal solutions for accounting firms to improve productivity and efficiency. Accounting and tax firms using Doc.It Suite software stay organized by streamlining and automating digital processes that drive efficiency, workflows and profitability while minimizing risk associated with dealing with the exchange and storage of financial documents. Doc.It was founded in 2001, is headquartered in Toronto, Canada and currently has 600 accounting firms and 16,000 users. There are three product options depending on your firms needs. 1. Doc.It Suite includes all functions of the software- Scan and Organize, document management, workflow, web portal, PDF Editor and all integrations. 2.. Doc.It Connect is focused around the web portal functionalities with the work binders for document storage. 3. Doc.It Explore is the starting point for document storage. and includes the PDF editor

Carizma QM is a web-based software that supports users in managing the entire lifecycle of regulated documents from authoring, review, approval and release to archiving. Creation and management of regulated documents, e.g. SOPs. Integrated workflows for review and approval. Automatic start of training workflow, read and understood upon approval. Electronic signature – 21 CRF part 11 compliant. Display of users who have read and understood. Validated and audit trail. Supports users to manage the entire lifecycle of regulated documents within Carizma-QM itself. The author defines key information e.g. document type (SOP, work instruction, form, checklist, etc.), title of document, process owner (department), groups of users to whom the document is applicable, review cycle. Users are defined in due time by e-mail when a document needs to be reviewed. Carizma creates the skeleton document.

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.

AmpleLogic's Quality Management Software (eQMS) is intricately crafted to meet the rigorous requirements of heavily regulated industries. The ISO 9001 certified cloud-based Quality Management System (QMS) is ideal for Lifesciences, Food & Beverages (F&B), Cosmetics, Medical Devices, Gene Therapy, and analogous sectors. As businesses acknowledge the challenges associated with manual quality checks—prone to both laborious efforts and errors—they are increasingly adopting QMS software solutions. These systems play a pivotal role in enhancing audit quality through process automation, efficient data management, and seamless API integration.