Alternatives to Greenlight Guru
Compare Greenlight Guru alternatives for your business or organization using the curated list below. SourceForge ranks the best alternatives to Greenlight Guru in 2025. Compare features, ratings, user reviews, pricing, and more from Greenlight Guru competitors and alternatives in order to make an informed decision for your business.
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Aizon
Aizon
Aizon: Intelligent GxP Manufacturing Aizon enables pharmaceutical and biotech manufacturers to transform operations with AI-powered solutions purpose-built for GxP environments. Our platform helps reduce variability, increase yield, and ensure product quality—consistently and at scale. Aizon Execute — Intelligent Batch Record (iBR): Digitize manufacturing in weeks, not months, reducing deviations and accelerating batch release. Aizon Unify — Contextualized Intelligent Lakehouse: Integrate and contextualize data across systems and sites to drive actionable insights for manufacturing excellence. Aizon Predict — GxP AI Industrialization: Deploy predictive AI to optimize critical process parameters, improve Right-First-Time rates, and boost yield. With Aizon, manufacturers move beyond compliance to achieve operational intelligence—analyzing the past, mastering the present, and shaping the future of production. -
2
Adaptive Compliance Engine (ACE)
PSC Software
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. -
3
Jama Connect
Jama Software
Jama Software® is focused on maximizing innovation success in multidisciplinary engineering organizations. Numerous firsts for humanity in fields such as fuel cells, electrification, space, software-defined vehicles, surgical robotics, and more all rely on Jama Connect® requirements management software to minimize the risk of defects, rework, cost overruns, and recalls. Using Jama Connect, engineering organizations can now intelligently manage the development process by leveraging Live Traceability™ across best-of-breed tools to measurably improve outcomes. Our rapidly growing customer base spans the automotive, medical device, life sciences, semiconductor, aerospace & defense, industrial manufacturing, consumer electronics, financial services, and insurance industries. -
4
Lockbox LIMS
Third Wave Analytics
A sample tracking, test result capture, and inventory management cloud LIMS for life science research, biotech/NGS, and industrial QC labs. Includes regulatory support for CLIA, HIPAA, Part 11, and ISO 17025. Nothing is more critical to a lab’s success than the quality, security, and traceability of samples. The Lockbox LIMS system provides robust sample management functionality to laboratory professionals, giving them full visibility on every aspect of a sample’s journey, from accessioning to long-term storage. LIMS analysis is about more than just tracking results- Lockbox’s multi-layered sample storage and location management functionality allows you to define your lab’s storage framework using a variety of location options: rooms, storage units, shelves, racks, boxes, and positions. -
5
Total Lean Management (TLM) Software
Lean & Mean Business Systems
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 OrdersStarting Price: $45/user/month -
6
Dot Compliance QMS
QMS for Life Sciences
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-ShopStarting Price: $10,000 / Annually -
7
SimplerQMS
SimplerQMS
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.Starting Price: $13,750/year -
8
Matrix Requirements
Matrix Requirements
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.Starting Price: $500 per month -
9
Qualityze EQMS Suite
Qualityze
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.Starting Price: $30/User/Month -
10
BPAQuality365
BPA Solutions
BPAQuality365 is a prebuilt QMS software to use in your secured Microsoft 365 cloud, leveraging tools used by collaborators daily, with no need to change user habits. It’s modern, compliant with any device, flexible to match your unique needs, and powered by innovative M365 technologies. The app includes powerful compliance document management, audit, non-conformance, CAPA action, risk, equipment, health, safety, environment modules compliant with ISO 9001, FDA Part 11 and medical regulations. The QMS app is closely integrated to discussion flows in Teams and enable instant quality improvement. Go a step further and reach your Quality 4.0 objectives by combining powerful AI features, best-in-class workflow automation, business intelligence and mobile Power Apps to run on any device. Benefit from BPA’s Microsoft Preferred status to configure your QMS to your needs, transfer knowledge to your power users and get trained on M365 technologies. -
11
QT9 QMS
QT9 Software
Struggling with complex compliance requirements or disconnected quality systems? QT9 QMS eliminates these challenges with one integrated, fully validated platform that scales with your business. Designed for life sciences, aerospace, and manufacturing, QT9 offers cloud or secure on-premise deployment to meet your needs. Stay audit-ready automatically with built-in FDA, ISO, and EU MDR compliance while reducing manual work by up to 70%. With 28+ modules included—like document control, CAPA, training, and supplier management—QT9 deploys fast without costly customization. Backed by ISO 27001 certification, unlimited support, and 20+ years of proven success, QT9 helps 1,100+ organizations accelerate compliance, improve visibility, and simplify quality management. Start your free trial or book a personalized demo today.Starting Price: $10,000/year -
12
ComplianceQuest
ComplianceQuest
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.Starting Price: $30 per user per month -
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ARMATURE Fabric
ARMATURE
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. -
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Intellect
Intellect
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. -
15
Qualio
Qualio
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. -
16
MasterControl
MasterControl
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.Starting Price: $25,000 / 1st year -
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Teamcenter
Siemens
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. -
18
Propel
Propel Software Solutions
Delight your customers and shareholders with compelling and profitable products. Buyers have evolved. Supply chains are in chaos. The very definition of a product has been upended. Yet product development technologies have not kept up. A new approach is needed. One that focuses on customer and patient outcomes. That helps product companies place the right bets. That engages markets with compelling products and experiences. We call this product value management (PVM). Efficiently develop and launch innovative products by collaborating with the entire value chain, including customers and suppliers. Manage part quality, design for product quality, and act decisively to address identified quality issues. Leverage a continuous, trusted source for product information to engage customers with enriched omnichannel product experiences.Starting Price: $73.00/month/user -
19
Cognidox
Cognidox Ltd
Cognidox is an online document management system for high-tech, medical device and life sciences product development sectors. Available in the cloud or as an on-premise solution, Cognidox promotes better product lifecycle management and knowledge transfer from developers to clients, partners, and customers. Secure and reliable, Cognidox provides plug-ins for various programs such as Microsoft Office, and we also offer a robust API so that you can integrate almost any process with Cognidox In addition to the core function as a DMS, an add-on for Cognidox also offers a way of allowing licensing and distribution of documents to third parties via fully sandboxed site so you have the power to publish specific documents whilst keeping your main storage secure. Another popular add-on is the gBMS - graphical Business Management System, Use Visio to easily capture your business processes, a good BMS should give you clear oversight of your entire operation.Starting Price: £10 p/user -
20
CAQ.Net
CAQ AG Factory Systems
CAQ AG Factory Systems has established itself as one of the worldwide leading providers of quality management software. We have over 30 years of experience in the development and distribution of modular, multilingual, and industry-specific management solutions for small and medium-sized enterprises as well as multinational corporations. Our CAQ.Net software suite covers every aspect of computer aided quality assurance and was designed with the highest degrees of adaptability and customizability in mind. Just like a construction kit, our system allows you to pick the most suitable building blocks and thereby create the perfect solution to your individual quality management demands. Why CAQ.Net? Updates, Upgrades & Release Changes Support from QM & IT Professionals User Workshops Screencasts Conformity to Standards Information Security SaaS or On-Premises Floating Licenses Multitenancy Multilingual No-Code-Designer Validation Capability AI Assistants ... -
21
TrialKit
Crucial Data Solutions
TrialKit is a unified eClinical platform that brings mobility, automation, and efficiency to modern research teams. Accessible from any browser or native app (iOS, Android, and Mac), TrialKit supports rapid study setup, real-time data collection, and centralized oversight—ideal for CROs and sponsors seeking agility without compromising compliance. Its drag-and-drop design tool makes it easy to build studies quickly, while advanced features like AI-powered reporting and mobile ePRO/eCOA enhance visibility and decision-making. Trusted by over 40,000 across the globe, TrialKit enables teams to work smarter from first patient in to database lock. Recognized with the 2024 SCDM Innovation Award, it’s the all-inclusive solution for today’s studies.Starting Price: $1700/month -
22
qmsWrapper
qmsWrapper
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.Starting Price: $250/month/10users -
23
meddevo
dytab GmbH
Discover a new way to manage the technical documentation of your medical devices with meddevo, a cloud-based tool crafted for the medtech industry. Seamless Digitization: Completely transform and automate your regulatory affairs process, ensuring you're always aligned with international standards, including EU-MDR, EU-IVDR, and ANVISA. User-friendly Experience: Using meddevo is as straightforward as filling out an online form. No steep learning curve, ensuring a smooth onboarding for your team. Effortless Integration: Import and export data with ease, making integration into your current systems straightforward. Top-tier Security: Hosted on the robust AWS platform, meddevo prioritizes your data's security. Activate 2-Factor Authentication (2FA) for an added layer of protection. Unrestricted Trial: Experience all that meddevo offers during the free trial, ensuring a comprehensive understanding of its capabilities.Starting Price: 249€/User -
24
Opvia
Opvia
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. -
25
Arena QMS
Arena, a PTC Business
Arena’s product-centric quality management system (QMS) software enables medical device manufacturers to deliver safe and compliant products to market fast. Arena QMS streamlines new product development and introduction (NPDI) by connecting quality and product processes. Arena QMS ensures regulatory compliance to quality standards and regulations including FDA 21 CFR Part 820, Part 11 and ISO 13485. Arena QMS enhances visibility and traceability by controlling quality processes in context with bills of materials (BOMs), SOPs, DMRs, DHFs, specifications, drawings, and training plans. -
26
InstantGMP
InstantGMP
If you’re relying on multiple software and/or paper-based solutions to manage your compliance and manufacturing process needs, InstantGMP™ could be the key that unlocks the next level of success for your business potential. Seamlessly maximize production uptime, improve batch quality and meet all FDA compliance needs—and more—all with an affordable, paperless, all-in-one software solution. InstantGMP™ products work individually and together based on your business needs to deliver comprehensive, integrated software solutions that ensure end-to-end quality, consistency and GMP compliance. We’ll help you pick the right solution set for your business needs today, and tomorrow. Organize, manage and document batches electronically while reinforcing good manufacturing practices. Inventory Management Solution that meets Part 11 and GMP requirements. Complete quality system that comes with SOPs, templates and guided workflows - ideal for virtual biotech. -
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SmartSolve eQMS
IQVIA
Eliminate manual, repetitive tasks so you can focus on delivering safer, more effective products – faster. IQVIA’s SmartSolve Postmarket Surveillance is your complete, SaaS approach for postmarket surveillance (PMS) and provides best practices for centrally managing all post market surveillance activities. Fusion is a SmartSolve and RIM Smart user event that provides an in-depth education into timely and relevant quality and regulatory topics with actionable insights and practical tools that can be applied within any Life Sciences organization. Fusion started as a live SmartSolve user conference and has evolved over the past couple of years to include virtual and live events for both SmartSolve and RIM Smart users. Simplify, automate and integrate your compliance response times, accuracy, predictive planning and efficiency with IQVIA SmartSolve™ Regulatory Connector. Connected Intelligence is our innovative, interconnected approach that helps to drive operational efficiencies.Starting Price: $542 one-time payment -
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Accevo Smart Factory
Accevo
Accevo Smart Factory is an all-in-one manufacturing operations platform that empowers factories to eliminate downtime, reduce waste, and accelerate digital transformation. Formerly known as ANT Solutions, Accevo offers intelligent modules for OEE monitoring, MES, MOM, APS, CMMS, QMS, and EMS—providing end-to-end visibility and control over production. The platform helps manufacturers transition to paperless operations while improving efficiency, energy management, and quality control. With cloud and on-premise deployment options, Accevo ensures scalability, security, and flexibility for every industrial environment. Its real-time analytics and AI-ready architecture enable faster decisions, improved productivity, and measurable ROI within weeks. Trusted by global brands like Recaro, Servier, and Fiat, Accevo leads the future of connected, data-driven manufacturing. -
29
ZipQuality
Consensia
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. -
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Tulip
Tulip
Tulip's flexible, no-code frontline operations platform helps manufacturers create front-end applications that guide operators, collect data from workers, machines, and devices, and track metrics against your KPIs. With Tulip, companies can digitally transform their operations in days, gaining real-time visibility of their operations to increase productivity, reduce errors, and drive continuous improvement.Starting Price: $1,200 per year -
31
QUMAS EQMS
Dassault Systemes
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. -
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AssurX
AssurX
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. -
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TrackWise
Honeywell International
Honeywell's TrackWise Digital® is a cloud-based Quality Management System (QMS) designed to help organizations efficiently manage quality and compliance processes. Leveraging nearly three decades of industry experience, it offers integrated modules that support various quality management aspects, including document control, training management, and corrective and preventive actions (CAPA). The platform incorporates advanced digital technologies such as artificial intelligence and machine learning to provide actionable, real-time insights, enabling proactive quality management. Its flexible, modular architecture allows for seamless integration with existing enterprise systems, facilitating rapid deployment and scalability. By streamlining quality processes and ensuring compliance with industry standards, TrackWise Digital® empowers organizations to bring products to market faster while minimizing risk.Starting Price: $200 per month -
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AmpleLogic eBMR
AmpleLogic
AmpleLogic eBMR stands out with its modular design and low code platform, offering tailored solutions for pharmaceutical and biotechnology industries. With features like real-time integration, dispensing modules, and electronic signatures, it ensures compliance with global regulatory standards. AmpleLogic eBMR boosts productivity by automating quality checks, cutting compliance costs, and streamlining batch reviews. Its electronic records prevent errors, ensuring precise decision-making. The software speeds up product changes, meets regulatory standards, and improves efficiency in pharmaceutical manufacturing. Specify raw materials and weight-age calculations. Optimize material management with precise dispensing. Facilitates routing, reviewing, and approval of manufacturing records. Streamlined batch review process for increased productivity. -
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RQM+
RQM+
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. -
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BabtecQ
Babtec Informationssysteme
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. -
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DELMIAworks
Dassault Systemes
Combine manufacturing, MES, supply chain, and ERP software to optimize your shop floor. Learn how DELMIAworks (formerly IQMS) can help increase visibility into every aspect of your manufacturing operation and solve your most trying production challenges. Prevent unnecessary downtime, while increasing manufacturing efficiency, quality, and profit margins. Improve decision making with real-time access to data across the entire supply chain. A single system for all ERP, manufacturing, MES, and supply chain requirements. Lower your overall cost of investment and maintenance by automating your business. Our easy-to-use solution can help you double plant output, eliminate human errors, and increase the efficiency of your production planning process. Manage, track and monitor the complete production process to eliminate unplanned downtime and increase throughput. OEE charts and graphs are dynamically updated with performance and quality data in real-time. -
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QT9 ERP
QT9 Software
QT9 ERP is a validated enterprise resource planning solution built for life sciences and other regulated manufacturers. Designed to connect production, inventory, quality, and accounting in one secure platform, QT9 ERP helps teams simplify operations and maintain full traceability from raw material to finished product. The system integrates seamlessly with QT9 QMS for end-to-end compliance visibility and audit readiness. Available cloud-based or on-premise, QT9 ERP supports FDA and ISO requirements while offering configurable workflows, real-time analytics, and multi-site control. With unlimited training, support, and system validation included, QT9 empowers organizations to eliminate manual processes, reduce production errors, and scale efficiently with confidence. Start your free trial or book a personalized demo today.Starting Price: $6000.00/one-time/user -
39
BatchLine
BatchLine
Purpose-built for Pharma and other GxP-regulated companies to digitize production, quality, and compliance for manufacturing operations. Let the data do the talking. Teams take actions from real-time event monitoring into performance, track and solve quality issues as they happen. Give operators a tool that's easy to use and helps them get it right first time. Manufacturing is a complex business, add in GMP regulations and it gets significantly more so. Providing your teams the right tools is an opportunity to solve significant problems and realise transformational improvement. Vastly reduce time and effort for batch review and approval through review-by-exception, no more reviewing entire batch records. Automate wasteful activities like manually inputting and verifying data, moving paper records around the shop floor, performing and checking calculations, workflow management and more. -
40
CaliberBRM
Caliber Technologies
In pharmaceutical manufacturing, recording shop floor activities in real-time are essential to ensure quality and compliance with 21 CFR Part 11 and GMPs. An automated system ensures that batch records are error-free and retrievable and the batch manufacturing processes are trackable. EBR software like CaliberBRM eliminates paper-based processes and risks associated with them to ensure data integrity and product quality. In life sciences and highly regulated industries, real-time entry recording of 4Ms is inevitable. It enhances the business process. You can save a lot of time and effort by digitalizing batch production records. Electronic Batch Record (EBR) System gives you complete control of the 4Ms. CaliberBRM reduces inventory wastage, checks and aligns manpower as per need, deals with instrument management, reduces review cycle time, etc. It in turn reduces operating costs. Quality Review Management (QRM) stresses performing review by exception to accelerate batch release. -
41
Nova-QMS
Novatek International
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. -
42
QEdge
Sarjen Systems Pvt Ltd
Sarjen's QEdge stands as a robust, risk-based enterprise Quality Management System, meticulously designed for the pharmaceutical manufacturing and broader life sciences industries. This comprehensive solution adeptly streamlines crucial quality processes, including Change Control, Deviation management, CAPA, efficient Document Management, and automated Training with SCORM-based eLearning. QEdge ensures stringent and full compliance with major regulatory standards such as FDA, EU-GMP, and ICH guidelines. By fostering operational excellence, maintaining impeccable data integrity, and guaranteeing audit-readiness in complex GxP environments, QEdge significantly enhances overall quality management. It provides essential process control and simplified vendor qualification, driving efficiency and superior quality across all operations. -
43
Ennov Quality Suite
Ennov
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 -
44
Quality Link
Quality Mapping Solutions
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. -
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Quality Connect
Montrium
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. -
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Momentum QMS
Momentum Systems
Let Momentum QMS be your guide to a world of volatility, uncertainty, complexity and ambiguity. Momentum QMS is the best way to meet your Quality, Safety and Compliance needs. A robust and responsive design allows you to use Momentum QMS from any device and for any function. Built-in reporting allows you to get the data you need, when and wherever you want. Stable, dependable and widely used Open Source software form the backbone of Momentum QMS. Momentum QMS is not resource hungry, it uses extremely efficient components that leave a tiny footprint. No more silos. Send and receive data from a multitude of sources to boost enterprise wide synergy. Multi-level authorization and role based security allows you to keep your knowledge and data secure. -
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Scilife
Scilife
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!Starting Price: $1000 -
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Harrington Quality Management Software (HQMS)
Harrington Group International
HQMS' applications include Document Control, Audits, Corrective Action, Calibration, Training, Material Nonconformance, PPAP, Project Management, Risk Management and the HQMS Supplier Portal. In business since 1991 – trustworthy source with SME Experts in Sales and Support will help with Business Case, Flexibility (on-premise or hosted, CapEx and Opex pricing models) with Support and Training & deployment planning that provides rapid learning curve with implementation guides. Secure deployment – including Single Sign On (SSO). Configuration and personalization features with customization if needed. HQMS is used cross several markets, including manufacturing (Aerospace and Defense, Automotive, Consumer Products, Medical Device, Food, Energy, and more), healthcare, retail, non-profits, and government.Starting Price: $500/month -
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QAD EQMS
QAD
QAD EQMS, formerly CEBOS, is a fully integrated enterprise quality solution that provides timely visibility into manufacturing and quality related issues. It facilitates a preventative approach resulting in reduced cost of quality, improved manufacturing throughput, improved customer satisfaction and higher manufacturing margins. QAD EQMS addresses the breadth of the value chain of suppliers and internal manufacturing to optimize quality performance. -
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Laurel MES
Laurus Infosystems
Laurel MES, is a browser-based and cloud-ready platform that has been designed by production engineers to ease operational difficulties in production lines/manufacturing facilities and for error-free batch production every time. A platform to drive, assign, manage and monitor all manufacturing activities from one dashboard. Laurel MES covers the complete manufacturing lifecycle from commercial production to final packaging. Compatible with all types of Pharma & Chemical Product Manufacturing. Laurel MES conceptualized and created by production engineers offers value-generating and error-reducing integrated solutions for all types of production lines in Pharma & Chemical domains. We have created a system that can be configured to completely replace your manual batch records with an electronic batch record that looks exactly like your physical Manufacturing record.