Best Electronic Batch Records (EBR) Software in the USA

The ultimate MRP solution for small manufacturers! MRPeasy offers an affordable, user-friendly, and cloud-based MRP system tailored specifically for small manufacturing businesses. Transform your customer orders into manufacturing orders and let the system schedule them automatically. It effortlessly books items from your inventory, and if needed, initiates purchase orders on your behalf. Depending on the real-time requirements, MRPeasy allows for both forward and backward scheduling. Automated checks ensure the availability of workers, workstations, and materials. Maintain a comprehensive overview of all your operations at all times! MRPeasy also smoothly integrates with premier accounting software such as QuickBooks and Xero, along with e-commerce platforms like Shopify and WooCommerce. This integration creates an all-encompassing business management solution that meets your every need.

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.

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.

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

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.

QT9 ERP is an all-in-one ERP platform with unlimited scalability. QT9 ERP gives you a fully-integrated solution with real-time analytics. Unify all your manufacturing, sales, inventory, purchasing and financial management functions with QT9™ ERP. 18+ interconnected modules enable you to manage Bill of Materials, Accounting, Sales Orders, Shipping, Invoicing, Inventory Control, Manufacturing, Purchasing, Inspections, Job Scheduling, Supplier Management & more in one platform. Digitally transform workflows with FDA 21 CFR Part 11 electronic signatures, electronic batch records, design history records, email reminders & dashboard views. Includes lot & serial number traceability. Integrate quality and compliance standards with QT9™ QMS integration available. QT9 ERP Automates Design History Records and Electronic Batch Records for Life Sciences, Medical Device Manufacturers, Pharma and Biotech Companies. A Compliance Portal for auditors is included along with expiring inventory alerts, lot & serial traceability along with barcoding for optimized inventory control. Get a free product tour! Start a Free 30-Day Trial. Visit QT9erp.com

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.

Azumuta is an all-in-one system to digitalize your shop floor operations. Become a paperless factory, save time in manual data entry, and prevent errors by creating and managing digital work instructions, audits, employee training, and quality management reports from a single platform.

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.

Greenlight Guru is the only product development and quality management platform designed specifically for medical device companies. The Medical Device Success Platform helps companies get safer products to market faster, simplifies FDA and ISO regulatory compliance, and provides a single source of truth by connecting the management of all quality processes like CAPAs, risk, audits, document control, training, design control, and more. Device makers across the globe are replacing their outdated paper-based and general-purpose legacy quality systems with Greenlight Guru to push beyond baseline compliance and achieve True Quality.

The L7 Enterprise Science Platform (L7|ESP®) is a comprehensive platform designed to contextualize data and remove business silos through process orchestration. This all-in-one solution supports the digitalization of data and scientific processes within life sciences organizations. It includes native applications like L7 LIMS, L7 Notebooks, L7 MES, and L7 Scheduling. L7|ESP seamlessly integrates with third-party applications, lab instruments, and devices to consolidate all data into a unified model. Featuring a low-code/no-code workflow designer and numerous pre-built connectors, it ensures rapid implementation and full automation. Utilizing a single data model, L7|ESP enhances advanced bioinformatics, AI, and ML to provide new scientific and operational insights. L7|ESP addresses the data and lab management needs and challenges within the life sciences sector, specifically targeting: ● Research and Diagnostics ● Pharma and CDMO ● Clinical Sample Management Explore the L7 Resource Center for on-demand recordings, case studies, datasheets, and more: l7informatics dot com/resource-center

Arena's product-centric QMS software allows medical device manufacturers to quickly bring safe and compliant products to the market. Arena QMS connects quality and product processes to streamline new product development and introduction (NPDI). Arena QMS ensures compliance with quality standards and regulations, including FDA 21 CFR Part 820 Part 11 and ISO 13485. Arena QMS improves visibility and traceability by monitoring quality processes in context of bills of materials (BOMs), DMRs and SOPs, as well as specifications, drawings and training plans.

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.

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.

We empower pharma companies and CDMOs with the tools to scale production while addressing supply-chain bottlenecks, complex materials, and rising development costs. Leverage AI and machine-learning to predict future outcomes with the leading manufacturing cloud. Always in compliance. Collecting and integrating real-time and historic data from multiple sources in a GxP compliant manner, and turning it into actionable insight. Use artificial intelligence (AI), machine learning, and other technologies to identify patterns that could lead to deviations. Fix them before they become a problem. The Aizon platform optimizes pharma manufacturing processes by using real-time data from disparate sources and predictive models. The Aizon platform allows for GxP-compliant acquisition, storage, consumption, and auditing. Aizon works closely with international regulatory bodies in order to ensure AI algorithms are qualified.

AmpleLogic eBMR is unique in its modular design, low-code platform and tailored solutions for the pharmaceutical and biotechnology industry. It ensures compliance to global regulatory standards with features such as real-time integration and dispensing modules. AmpleLogic eBMR increases productivity by automating quality controls, reducing compliance costs, and streamlining the batch review process. Its electronic records prevent errors, ensuring precise decision-making. The software improves the efficiency of pharmaceutical manufacturing, speeds up product changes and meets regulatory standards. Calculate weight-age and specify raw materials. Material management is optimized with precise dispensing. Facilitates routing, reviewing and approval of manufacturing records. Streamlined batch-review process for increased productivity.

POMS's continued investments in MES Research and Development result in an MES system that is flexible, simple to learn, and doesn't require customization. None of our customers today use a customized solution. POMSnet Aquila, a web-based manufacturing execution software (MES), is designed for Life Sciences manufacturing. POMSnet Aquila is 100% web-based and uses Microsoft.NET technology and HTML5. It provides customers with an easy to use interface that can be deployed quickly and maintained at a low cost. POMSnet Aquila provides recipe and specification management, material management, equipment management and production order management. It also allows for recipe execution, electronic batch records and device history. POMSnet uses best practices and business logic to support Pharmaceutical Manufacturing Execution Systems.

Opcenter Execution Pharma, formerly "SIMATIC IT eBR", is a dedicated MES solution that Siemens Digital Industries Software has created for the pharmaceutical industry. It enables paperless manufacturing and full electronic batch record. Opcenter Execution Pharma offers advanced features to design, streamline and manage production operations and processes. It seamlessly integrates the MES, automation, and enterprise resource planning (ERP). Opcenter Execution Pharma optimizes the manufacturing process by consolidating and optimizing all available manufacturing resources, including people, equipment, and products. It allows for real-time production execution and analysis of process quality information. This helps to optimize production activities, from order creation to finished products.

DeltaV S-series Electronic Marshalling (CHARMs) allows you to land field cabling anywhere you want, regardless if you use any signal type or control strategy. The DeltaV™, Distributed Control System (DCS), is an automation system that simplifies operations and lowers project risks. The state-of the-art range of products and services improves plant performance and is easy to maintain and operate. The DeltaV DCS scales easily to meet your requirements, without adding complexity. The DeltaV system integrates with other systems, such as batch, advanced control, change management and engineering tools.

Laurel MES is a browser-based, cloud-ready platform designed by production engineers to reduce operational difficulties in production lines/manufacturing plants and ensure error-free batch production. All manufacturing activities can be managed, assigned, managed, and monitored from one platform. Laurel MES covers all aspects of manufacturing, from initial production through final packaging. Compatible with all types and sizes of Pharma & Chemical Product Manufacturing. Laurel MES was designed and developed by production engineers. It offers integrated solutions that generate value and reduce errors for all types of production lines within the Pharma & Chemical domains. We have designed a system that can be used to replace manual batch records with electronic batch records that look exactly like your Manufacturing record.

Recording shop floor activities in real time is essential for pharmaceutical manufacturing. This helps ensure compliance with 21 CFR Part 11 (GMPs) and quality. Automated systems ensure that batch records are accurate and easily retrievable, and that the manufacturing processes can be tracked. CaliberBRM, an EBR software, eliminates paper-based processes. This reduces the risk and improves product quality and data integrity. Real-time recording of 4Ms in life sciences and other highly regulated industries is a necessity. It improves the business process. Digitalizing batch production records can help you save time and effort. The Electronic Batch Record (EBR), System gives you complete control over the 4Ms. CaliberBRM reduces inventory waste, checks and aligns manpower according to need, manages instrument management, reduces review cycles, etc. It also reduces operating expenses. Quality Review Management (QRM), stresses the importance of performing exception review to speed up batch release.

Your team can take control of the process. Your team can take control of the process with an intuitive, no-code procedure. Our native mobile app and voice-enabled headset can move with you. Tempo is optimized to be used in all environments, including the suite, cleanrooms and while wearing PPE.

Designed specifically for Pharma and GxP-regulated organizations to digitize production, compliance, and quality for manufacturing operations. Let the data speak for themselves. Teams can take action from real-time monitoring of events into performance. They can track and solve issues with quality as they occur. Give operators an easy-to-use tool that helps them get the job done right on the first try. Manufacturing is complex. Add GMP regulations to the mix and it becomes even more so. By providing your teams with the right tools, you can solve major problems and achieve transformational improvements. Review-by-exception reduces time and effort required for batch approval and review. No more reviewing batch records. Automate wasteful tasks like manually entering and verifying data and moving paper records across the shop floor.