Alternatives to Greenlight Guru

Qualio is a one-stop solution for quality and compliance management. It's ideal for growing companies in healthcare and life sciences. Qualio is reliable, affordable and easy to use. It helps companies build life-saving products faster and achieve 100% ISO, GxP and FDA compliance. Qualio makes it easy for companies to manage document control, training and NCRs, audits as well as suppliers, complaints, and other tasks in one platform.

Aizon: Intelligent GxP Manufacturing Aizon helps life sciences manufacturers modernize production with AI solutions designed for regulated GxP environments. By leveraging our platform, companies can minimize variability, maximize yield, and safeguard product quality at every stage of the process. - Aizon Execute — Intelligent Batch Record (iBR): Move from paper to digital records in a matter of weeks, cutting deviations and enabling faster batch release. - Aizon Unify — Contextualized Intelligent Lakehouse: Break down data silos by unifying and contextualizing information across plants and systems, turning raw data into actionable insight. - Aizon Predict — GxP AI Industrialization: Apply predictive intelligence to optimize process parameters, strengthen Right-First-Time performance, and drive higher output. With Aizon, pharmaceutical and biotech manufacturers can unlock operational intelligence—gaining clarity from historical data, visibility into the present, and foresight to steer the future of manufacturing.

Adaptive Compliance Engine® (ACE®) is a highly configurable, workflow based eQMS/eDMS and more that can adapt to any business process, allowing for real-time tracking, management, and reporting of all compliance, quality, and operational activities. With ACE®, you will minimize the administrative hassles and maximize ROI with productivity gains from day one – all while 21 CFR Part 11 compliant. 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! 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. 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.

Jama Connect®, a product development platform, uniquely creates Living Requirements™. This digital thread is created through siloed, test, and risk activities to provide end to end compliance, risk mitigation, process improvement, and compliance. Companies creating complex products, systems, and software can now define, align, and execute on what they need. This reduces the time and effort required to prove compliance and saves on rework. You can be sure of success by choosing a solution that is easy-to-use, flexible, and offers support and services that are adoption-oriented.

A cloud LIMS that tracks samples, tests results, and manages inventory for life science research, industrial QC labs, and biotech/NGS. Includes regulatory support for CLIA and HIPAA, Part 11 and ISO 17025. The quality, security, traceability, and traceability for samples is crucial to a lab's success. Laboratory professionals can use the Lockbox LIMS system to manage their samples. They have full visibility of every step of the sample's journey from accession to long-term storage. LIMS analysis is more than just tracking results. Lockbox's multilayered sample storage and location management functionality lets you define your lab's storage structure using a variety location options: rooms and storage units, shelves and racks, boxes and boxes.

Dot Compliance offers the industry's first ready to use Quality Management Solution powered by the Salesforce.com platform. The Dot Compliance solution includes an extensive set of off-the-shelf ready eQMS and compliance pre-configured processes, enabling customers to deploy quickly and cost effectively. Dot Compliance ready to use solutions include full project validation services and product validation packages. Dot Compliance offers the industry’s most cost-effective quality and compliance management solution available, allowing users to quickly deploy flexible and scalable solutions. Automate core quality processes such as Document Management, Training Management, CAPA, Audits, Customer Complaints, Change Management, Supplier Quality, and more. Our solution is fully configurable and offers seamless integration abilities, with easy adaptation and implementation of customer’s specific requirements.

TLM QMS Software is a powerful and robust quality, risk and material management software (QMS) which is validated and 21 CFR Part 11 compliant. TLM is a cutting-edge, all-in-one quality management system that can be customized to integrate with online CRM software, QuickBooks or ERP databases. Total Lean Management (TLM) QMS Software is specifically intended to be a low cost, highly integrated, flexible and continuously improving landscape to which specialty systems can be added where needed to create the digital business landscape that enables work flows the way your company needs them to work.

Streamline every stage of the development lifecycle with a flexible solution built for SxMD. Efficiently manage design controls from requirements to compliance with end-to-end traceability to mitigate risk. Innovate faster with a flexible item-based approach to documentation designed to meet even the most complex SxMD product needs. Enhance quality management with full traceability from design input to output with a purpose-built software platform that enables a collaborative quality culture across all teams. Take charge of evolving design, quality, and regulatory requirements while empowering team autonomy and get your product on the front line faster. Ensure frictionless alignment between platforms with native integrations for Jira, GitLab, GitHub, Azure DevOps and more. Leverage our REST API to connect with all your tools.

SimplerQMS offers a cloud-based Quality Management Software, specifically designed for the Life Science industry. SimplerQMS 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, and ICH Q10, among others. The system is fully validated according to GAMP5. The system offers a range of Life Science QMS modules such as Document Control, Change Control, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, Quality KPIs and more. SimplerQMS integrates with Microsoft Office and allows users to work with documents in applications such as Word, PowerPoint, and Excel. Overall, SimplerQMS delivers efficient, paperless workflows that align with the compliance requirements of the Life Science industry.

BPAQuality365, a QMS software, can be used in your secure Microsoft 365 cloud. It leverages tools used daily by collaborators and does not require you to change your user habits. It is modern, compatible with all devices, adaptable to your specific needs, and powered through innovative M365 technologies. The app includes powerful compliance document management, audit, non-conformance, CAPA action, process and process maps, incident, change, risk, FMEA, SWOT, equipment, health, safety, environment modules compliant with ISO 9001, FDA Part 11 and medical regulations. The QMS app integrates with Teams discussions and users can ask the QMS while chatting in Teams and share QMS card with their colleagues. You can go further to achieve your Quality 4.0 goals by combining powerful AI features with best-in-class workflow automation and business intelligence. BPA's Microsoft Preferred status allows you to customize your QMS to meet your needs, share knowledge with your power users, and learn about M365 technologies.

Qualityze EQMS Suite is a next-generation Enterprise Quality Management Software. It is specifically designed for businesses to efficiently manage their quality processes, customer expectations and compliance requirements. It helps them address operational challenges so they can achieve excellence in terms of quality, safety and reliability. It comes with pre-defined templates for controlled documents, audit checklists, regulatory forms, material compliance reports and many more. Qualityze EQMS Suite is a set of 14 integrated modules that help create a closed-loop system to manage end-to-end quality from anywhere. Our range of smarter quality solutions is built on the Salesforce.com technology platform. These modules are Nonconformance Management, CAPA Management, Document Management, Change Management, Audit Management, Training Management, Supplier Quality Management, Inspection Management, Customer Complaints Management, Material Compliance Management, Forms Management, Permit Management, Calibration Management, and Maintenance Management, Forms Management and Field Safety Management. Our Quality Management solutions help create a culture of quality and continuous improvements by proactively mitigating quality issues.

Mar-Kov is a leader in providing cost-effective software solutions to the pharmaceutical, chemical and cosmetics, flavors, fragrance, paints and coatings, as well as food industries. Mar-Kov provides robust traceability solutions to process, batch, or formulation-based manufacturers. This helps businesses automate their daily routines and streamline operations while complying with regulatory requirements such as HACCP, FDA, etc. This solution promotes paperless inventory through the use of barcoding and an electronic batch record system.

Unify quality processes with QT9's all-in-one cloud-based QMS Software Suite. QT9 QMS is a user-friendly quality management software that includes 25+ modules with unlimited scalability. Automate ISO & FDA Compliance with email alerts, To Do lists and FDA 21 CFR Part 11 Compliant Electronic Approvals. QT9 QMS enables Life Sciences, Biotechnology Companies, Medical Device Manufacturers and Pharmaceutical Companies to digitally transform operations. Get real-time status updates and visualize quality metrics up-to-the-minute. QT9 QMS comes with built-in document control, revision-level controls, corrective actions (CAPAs), Nonconforming products and more. Advance product releases with Deviation Management, Engineering Change Orders, FMEA, Inspection Management Modules Included. Go paperless & put time-consuming tasks on autopilot. QT9 QMS comes ready-to-use. Get a free product tour! Start a Free Trial. Visit QT9qms.com

ARMATURE Fabric™ provides a comprehensive solution for overseeing your accreditation, certification, credentialing, audit, quality, and compliance processes all within one cohesive platform. By utilizing our software, you can enhance efficiency, improve security, and deliver superior service to your stakeholder communities. No matter if you are working with institutional, programmatic, or specialized accreditation programs, certifying various individuals or organizations, conducting thorough audits, or addressing non-conformances, ARMATURE Fabric streamlines these activities for both you and your stakeholders, ensuring a more productive experience. Our cloud-based software ensures data collection through a variety of methods, including online applications, assessments, audits, inspections, surveys, and self-evaluations. Additionally, it allows you to handle workflows related to accreditation, certification, audits, and compliance while efficiently managing documents and identifying issues. With features that enable reporting and trend analysis, ARMATURE Fabric empowers organizations to proactively adapt and improve their practices.

Natively built and operated on the Salesforce platform, QHSE is the fastest growing Enterprise Quality, Health and Safety Management System. Unified QHSE solutions combine EQMS with EHS to help customers of all sizes deliver high quality products and services in a safe and sustainable manner. They reduce risk, inefficiencies, and inefficiencies, while protecting their customers, employees, and brand.

It can seem like a never-ending series of tradeoffs to bring breakthrough products to market within highly regulated industries. MasterControl's GxP software simplifies workflows, so you don't have to compromise quality for cost or innovation with regulation. Complete and connected meets flexible and fast. MasterControl Quality Excellence transforms quality data and processes to a competitive edge. Modern software is the first step in modernizing your manufacturing operations. MasterControl Manufacturing Excellence, from work orders to production records (EBR/eDHR), to logbooks and work instructions, is the easiest way to digitalize manufacturing.

Intellect's QMS software has been proven to improve quality operations and reduce overall quality cost by up to 40%. Our apps were designed by certified quality professionals and can be easily customized with our no-code platform or drag-and-drop technology. Remote access for your team, mobile apps, dynamic workflows, analytics, reporting, and remote access are all possible with this modern and simple solution. Apps include Document Control and Employee Training, Audit Management CAPA, Nonconformance, as well as other useful features.

Opvia empowers R&D, Manufacturing and Quality Management teams to build custom Process Operating Systems that streamline their workflows, giving them a competitive advantage. We work with startups and enterprises in a variety of industries including biotech, pharmaceuticals, food and beverage, engineering, and medical devices to digitize their processes. Our powerful tools and expert assistance give companies the freedom they need to create and deliver in a way that has never been possible before.

Teamcenter® software represents a contemporary and flexible product lifecycle management (PLM) solution that integrates individuals and workflows across various functional areas through a cohesive digital thread that fosters innovation. Its extensive and diverse portfolio empowers organizations to tackle the complex challenges associated with creating highly successful products. With a user-friendly interface that is both simple and intuitive, Teamcenter enables team members from all corners of the organization to engage in the product development journey more seamlessly than ever. Regardless of your deployment preference—whether on-premises, in the cloud, or via the SaaS option Teamcenter X—you will access the same reliable capabilities that are tailored to accelerate your innovation. Begin your journey with Teamcenter by managing product data and processes, encompassing 3D designs, electronics, embedded software, documentation, and your bill of materials (BOM). By utilizing your product information across a wider range of domains and departments, you can achieve significantly improved returns on your PLM investment. Ultimately, Teamcenter not only streamlines operations but also enhances collaboration, making it an essential tool for modern product development.

TrialKit is a cloud-based platform available via both a web and native mobile app, enabling end-to-end clinical trial management for medical device, diagnostics, digital therapeutics, and biopharma companies of all sizes. Design and deploy validated studies in days not weeks using our intuitive study builder that requires no programming. Thousands of global users have leveraged the flexibility of TrialKit to deploy over 8,000 studies across all phases of development.

Your customers and shareholders will be delighted by your profitable products. Buyers have changed. Supply chains are in chaos. The definition of a product is being redefined. However, product development technologies have not kept pace. We need a new approach. One that is focused on patient and customer outcomes. This helps product companies make the right decisions. This engages markets with engaging products and experiences. This is called product value management (PVM). Collaboration with all stakeholders, including suppliers and customers, is essential to develop and launch innovative products. Design for product quality and manage part quality. Take action to resolve quality issues. To engage customers with enhanced omnichannel product experiences, leverage a trusted source of product information.

CAQ.Net software solutions are in action all around the globe wherever it is important to ensure the quality, safety, and functionality of products and services. Whether strategic quality management or operational quality assurance – thanks to its high degree of automation and uniform data structure, CAQ.Net facilitates effective process management, proactive failure prevention, and a company-wide quality mindset.

Cognidox is an online document-management system for high-tech, life sciences and medical device product development. Cognidox is available in the cloud and as an on-premise solution. It promotes product lifecycle management and knowledge sharing between developers and clients, partners, customers, and customers. Cognidox is secure and reliable. We offer plug-ins for many programs, such as Microsoft Office. We also offer an API that allows you to integrate almost any process with Cognidox. Cognidox's core function is a DMS. An add-on for Cognidox allows you to license and distribute documents to third parties via a fully sandboxed website. This allows you to publish specific documents while keeping your main storage secure. Another popular add-on is gBMS - Graphical Business Management System. Visio can be used to capture your business processes. A good BMS should give clear oversight of your entire operation.

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. Best For 1. For companies who need guidance to implement and adopt validated QMS. 2. For companies who want to automate their quality management and go beyond a paper-based system.

With meddevo, each team member has a workspace where they can create, manage and automate technical documentation of medical devices and IVDs. A turnkey SaaS. Run Changes, CAPAs, complaints and custom processes directly in the system. Due to the full eQMS/eTD sync, you will gain maximum insight. Reduce the administrative burden and process time to a minimum.

InstantGMP™, which replaces multiple software and/or paper-based solutions for managing your manufacturing and compliance needs, could be the key to unlocking your business's full potential. With a single, affordable software solution, you can easily increase production uptime, improve batch quality, and meet all FDA compliance requirements. InstantGMP™, which can be used individually or together depending on your business needs, delivers comprehensive, integrated software solutions that ensure quality, consistency, and GMP compliance. We will help you choose the right solution for your business today and tomorrow. You can organize, manage, and document batches electronically while promoting good manufacturing practices. Inventory Management Software that meets Part 11 requirements and GMP requirements. A complete quality system with templates, SOPs and guided workflows that is ideal for virtual biotech.

Arena's quality management system (QMS) software, designed specifically for product-centric environments, empowers medical device manufacturers to efficiently bring safe and compliant products to the market. By integrating quality and product processes, Arena QMS simplifies the new product development and introduction (NPDI) process. It provides assurance of regulatory compliance with essential quality standards and regulations, such as FDA 21 CFR Part 820, Part 11, and ISO 13485. Furthermore, Arena QMS improves visibility and traceability by managing quality processes in conjunction with various essential documentation, including bills of materials (BOMs), standard operating procedures (SOPs), device master records (DMRs), design history files (DHFs), specifications, drawings, and training plans. This holistic approach not only facilitates compliance but also fosters a culture of quality throughout the organization.

Streamline tedious and repetitive tasks so you can concentrate on delivering products that are both safer and more effective, and do so at a quicker pace. IQVIA’s SmartSolve Postmarket Surveillance offers a comprehensive SaaS solution for postmarket surveillance (PMS), equipping you with best practices for the centralized management of all PMS activities. The Fusion event, tailored for SmartSolve and RIM Smart users, provides extensive education on pertinent quality and regulatory subjects, offering actionable insights and practical tools applicable across any Life Sciences organization. Initially launched as a live conference for SmartSolve users, Fusion has transformed over recent years to encompass both virtual and in-person events for the broader SmartSolve and RIM Smart communities. Enhance your compliance response times, accuracy, predictive planning, and overall efficiency through the IQVIA SmartSolve™ Regulatory Connector. This Connected Intelligence framework represents our forward-thinking, integrated strategy aimed at fostering significant operational efficiencies across the board, ultimately benefiting your organization in numerous ways. Embrace these advancements to ensure your organization remains competitive in a rapidly evolving landscape.

Accevo Smart Factory (formerly ANT Solutions) is a next-generation Manufacturing Operations Management (MOM) platform built to help factories modernize and thrive in the Industry 4.0 era. Designed for end-to-end digital transformation, it connects production lines, machines, and people in a unified ecosystem. Its suite includes OEE performance monitoring, MES, CMMS, APS, QMS, and EMS, giving manufacturers full control of performance, planning, maintenance, and energy use. By digitizing workflows and eliminating manual reports, Accevo helps reduce downtime, increase efficiency, and deliver up to 15% higher OEE within weeks. The platform supports both cloud-native and on-premise deployments, ensuring security, scalability, and easy integration with ERP systems. AI-driven analytics and real-time dashboards empower teams to react 65% faster to production issues while cutting reporting time by 90%. Accevo’s proven implementation methodology guarantees measurable results in as little as six weeks. Backed by a team of industrial automation experts, Accevo transforms complex operations into streamlined, data-powered systems for global leaders in manufacturing.

ZipQuality offers a software-driven service designed to aid medical device manufacturers in launching innovative products. Our collaborative platform adeptly manages swift design modifications for agile teams while upholding regulatory standards. With a pre-configured system that incorporates processes and tools, there’s no necessity to modify your existing quality system. The integrated platform efficiently accommodates rapid design iterations for product documentation. Our team of seasoned consultants supports your team throughout the entire process. Built on the robust ENOVIA platform, our comprehensive, scalable software tools are tailored to meet your needs. This integrated solution allows for quick design adjustments while ensuring that product documentation and data remain synchronized and that all records are maintained in a state ready for audits. We cover essential areas such as product, hardware, and software requirements. Our expertise extends to the complexities of software-heavy medical devices. The ZipQuality framework is founded on a structured documentation approach that enhances systems engineering, promotes effective risk management, and ensures transparent traceability, making it an invaluable asset for any medical device company. Additionally, our commitment to continuous improvement means we regularly update our service offerings to align with industry advancements.

Tulip's flexible, non-code frontline operations platform allows manufacturers to create front-end apps that guide workers, collect data from machines and workers, and track metrics against your KPIs. Tulip allows companies to digitally transform their operations within days. They can gain real-time visibility into their operations to improve productivity, reduce errors and drive continuous improvement.

To expedite the introduction of new products while adhering to international regulations, companies must streamline and automate their processes for gathering, monitoring, analyzing information, and addressing related challenges. QUMAS EQMS, previously known as ProcessCompliance, is a cloud-based platform designed for Enterprise Quality and Process Management, offering extensive integrated solutions for regulatory, quality, and compliance management within a validated Quality Management System (QMS) framework. By leveraging QUMAS’s data-centric methodology, organizations can adeptly manage quality-related content and easily access and repurpose quality data, ensuring thorough visibility into the quality landscape. Furthermore, QUMAS features interactive quality dashboards that provide an overview of QMS performance across various business sectors and quality initiatives. Users can generate reports that are easily exportable, shareable via email, or scheduled for regular updates. This platform also facilitates secure, efficient, and compliant information exchange among QMS departments in the cloud, enhancing collaboration and operational efficiency. Ultimately, QUMAS empowers organizations to meet their quality objectives while navigating the complexities of regulatory compliance.

The AssurX platform is a powerful software platform for enterprise quality management (EQMS) and regulatory compliance to reliably communicate and coordinate information, documentation, and activities. AssurX allows regulated businesses to quickly identify and control quality issues and risk exposure to avoid quality or noncompliance problems while improving workflow. AssurX QMS software is uniquely 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. No other system is easier to deploy, configure, and modify. AssurX solutions integrate seamlessly to create a connected quality system. Solutions include audit management, corrective actions, training management, compliant management, document management, change control, risk management, EHS incident management, and more.

RQM+ stands as a prominent global provider of medical technology services, dedicated to accelerating compliance and ensuring market success for its clients. With a wealth of expertise and deep industry insight, we offer tailored solutions that streamline the entire product lifecycle for medical technology firms, guiding them from initial concept through to commercialization and beyond. Our comprehensive suite of services facilitates seamless end-to-end solutions that encompass every stage of the medical device development process. The quality assurance engineers at RQM+ meticulously evaluate material lists, establish supplier networks, and assist in navigating the design change process. Likewise, our design quality engineers are instrumental in overseeing crucial aspects such as packaging, sterility, biocompatibility, and required device testing. Our regulatory affairs consultants play a vital role by providing expert guidance and assistance with submissions to the FDA, notified bodies, and other regulatory agencies. Additionally, we leverage our significant experience with current reimbursement requirements and value-based compensation frameworks to enhance our clients' market positioning. Ultimately, RQM+ is committed to empowering medical technology companies to achieve their goals efficiently and effectively.

AmpleLogic eBMR differentiates itself through its flexible modular architecture and user-friendly low-code platform, providing customized solutions specifically designed for the pharmaceutical and biotechnology sectors. It boasts features such as real-time data integration, dispensing modules, and electronic signatures, which collectively ensure adherence to international regulatory requirements. By automating quality control processes, AmpleLogic eBMR enhances productivity, reduces compliance expenses, and simplifies the batch review process. Its electronic record-keeping capabilities minimize errors, leading to more accurate decision-making outcomes. Additionally, the software accelerates product modifications, aligns with regulatory standards, and boosts overall efficiency in pharmaceutical manufacturing. It allows for detailed specifications of raw materials and precise weight-age calculations, thereby optimizing material management through accurate dispensing methods. Furthermore, the system streamlines the routing, reviewing, and approving of manufacturing records, contributing to a more efficient batch review process that ultimately drives productivity levels higher. This comprehensive approach not only meets industry demands but also positions businesses for sustained growth.

To optimize your shop floor, combine manufacturing, MES and supply chain software. Learn how DELMIAworks, formerly IQMS, can help you improve visibility into every aspect your manufacturing operation and solve the most difficult production problems. Reduce downtime and increase manufacturing efficiency, quality, profit margins, and quality. Real-time data access across the entire supply chain can improve decision making. All ERP, manufacturing, MES and supply chain requirements can be handled by one system. Automating your business can lower your investment and maintenance costs. Our simple-to-use solution will double your plant output, eliminate human error, and improve the efficiency of production planning. To eliminate unplanned downtime, increase throughput and reduce downtime, manage, track and monitor all aspects of the production process. OEE graphs and charts are dynamically updated with performance data and quality data in real time.

Honeywell's TrackWise Digital® serves as an innovative cloud-based Quality Management System (QMS) aimed at enhancing the efficiency of quality and compliance processes within organizations. Drawing on nearly thirty years of expertise in the field, it features integrated modules that cater to various elements of quality management, such as document control, training oversight, and corrective and preventive actions (CAPA). The platform utilizes cutting-edge digital technologies, including artificial intelligence and machine learning, to deliver actionable insights in real-time, which fosters a proactive approach to quality management. Its adaptable, modular framework ensures smooth integration with current enterprise systems, allowing for quick deployment and growth. By optimizing quality processes and maintaining adherence to industry regulations, TrackWise Digital® enables organizations to accelerate product launches while effectively reducing risks. This comprehensive system not only enhances operational efficiency but also supports continuous improvement initiatives across the quality management spectrum.

QAD EQMS (Enterprise Quality Management System) is a fully integrated enterprise quality management system that provides timely visibility into manufacturing and quality-related issues across the enterprise. It facilitates a preventative approach that helps to build quality into the process from the product design phase.

We provide quality management software, offering comprehensive QM solutions tailored for all quality-related tasks, a tradition we've upheld for 25 years. As experts in the field, we have created a versatile quality management solution through our modular software, BabtecQ. Additionally, we present Babtec Qube, a cloud-based platform designed to facilitate collaboration with your suppliers and customers for effective management of your quality tasks. Our offerings empower you to visualize the complete spectrum of quality processes, both within your organization and with external partners, for a quality experience you will be eager to share. If you're interested in enhancing your understanding of quality management principles, you've found the perfect resource! Our knowledge pages offer insights into various topics, such as complaint management and the 8D report. Furthermore, the System FMEA, often referred to as system analysis, serves as a critical component of the FMEA (Failure Mode and Effects Analysis) process, focusing on the evaluation of an entire system to ensure that all individual components function together seamlessly. As you explore these resources, you will gain valuable insights into the intricacies of quality management, equipping you with the knowledge to implement effective practices in your organization.

Sarjen offers QEdge, a powerful Quality Management Solution. This risk-based enterprise software for life sciences streamlines critical processes like Change Control, Deviation, CAPA, and Document Management. QEdge ensures full regulatory compliance (FDA, EU-GMP, ICH), driving operational excellence, data integrity, and audit-readiness in GxP environments, enhancing quality control and overall efficiency.

Ensuring uniform product quality and robust quality management procedures poses significant challenges in the current landscape of pharmaceutical manufacturing. Industries governed by strict regulations, including Pharmaceuticals, Biotechnology, and Life Sciences, must adhere to Good Manufacturing Practices (GMP) to comply with legal standards. Beyond merely fulfilling GMP obligations, it is essential to provide evidence of compliance. Relying on paper forms, isolated systems, or manual procedures to oversee, monitor, and document quality issues and responses fails to offer effective solutions for establishing cohesive and integrated quality management practices that align with industry standards. Consequently, organizations must seek more advanced and automated systems to enhance their quality assurance efforts and streamline compliance.

In the realm of pharmaceutical production, it is crucial to document activities on the shop floor in real-time to maintain quality standards and comply with regulations such as 21 CFR Part 11 and Good Manufacturing Practices (GMPs). Utilizing an automated system guarantees that batch records are free from errors and can be easily accessed, while also allowing for the tracking of batch manufacturing processes. Electronic Batch Record (EBR) software, such as CaliberBRM, replaces traditional paper-based systems, thereby mitigating associated risks and ensuring the integrity of data and product quality. In industries that are highly regulated, particularly in life sciences, the real-time recording of the 4Ms becomes a necessity as it streamlines business processes. Transitioning to digital batch production records can significantly reduce both time and effort. The EBR system provides comprehensive oversight of the 4Ms, enabling organizations to minimize inventory waste, optimize workforce allocation, manage instruments effectively, and shorten review cycles, all of which lead to decreased operational costs. Furthermore, Quality Review Management (QRM) emphasizes the importance of exception-based reviews to expedite batch releases, enhancing overall efficiency. By implementing these modern solutions, companies can create a more agile and responsive manufacturing environment.

Quality Link 7 is designed with a focus on both individuals and technology, leveraging our extensive experience and established platform to assist organizations in streamlining processes, reducing costs, and ensuring regulatory compliance through an intuitive business operating solution. By utilizing our document management module, Quality Link enhances efficiency and eliminates the need for cumbersome manual paperwork, allowing for seamless storage and management of every document generated. Users can conveniently print "uncontrolled" copies of documents and engage in a variety of document-related tasks directly within the module. This strategic organization significantly cuts down on clerical work performed by quality personnel by up to 90 percent. Our software also simplifies the transition by effortlessly converting documents from your former management system without any learning curve, while easily integrating with your preferred applications. With Quality Link, you can finally eliminate the burdensome task of manual document upkeep that often necessitates ongoing supervision, empowering your team to focus on more strategic initiatives. Additionally, the user-friendly interface ensures that all staff members can navigate the system with ease, further enhancing productivity across the board.

QT9 ERP helps manufacturers in regulated industries simplify production, inventory, and compliance with one connected, validated platform. Seamlessly integrating with QT9 QMS, it delivers real-time visibility, end-to-end traceability, and automated FDA and ISO compliance. Available cloud-based or on-premise, QT9 ERP includes built-in validation, configurable workflows, and unlimited support to help teams reduce errors, boost efficiency, and stay audit-ready.

Ennov Quality Suite. A comprehensive QMS to increase efficiency and ensure compliance. Ennov Quality Suite Ennov Quality Suite combines the power of Ennov Doc and Ennov QMS with Ennov Report and Ennov Training to create an integrated quality management solution that improves operational efficiency and ensures compliance to industry standards like 21 CFR Part 11, GxP, and ISO. Ennov Quality offers a predefined inventory that includes quality documentation, processes, and workflows. These are based on industry standards and best practices. Ennov Quality customers can quickly get their system in production and begin to realize their return on investment. Ennov Quality, as all Ennov solutions, is easy to set up and requires no IT skills. A unified and intuitive content and information management platform that supports and enriches the entire Life Sciences product cycle. Our comprehensive QMS improves operational efficiency