Best Electronic Batch Records (EBR) Software in South America

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.

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.

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.

Siemens Digital Industries Software has introduced Opcenter Execution Pharma, previously referred to as "SIMATIC IT eBR," which is a specialized MES solution tailored for the pharmaceutical sector, facilitating entirely paperless production and comprehensive electronic batch recording. This innovative platform boasts sophisticated capabilities for designing, refining, and overseeing both manual and automated production activities, achieved through seamless integration with MES, automation, and enterprise resource planning (ERP) systems. By optimizing the utilization of various manufacturing resources—such as equipment, personnel, processes, and products—Opcenter Execution Pharma plays a crucial role in promoting efficient production. It delivers real-time insights into manufacturing execution along with access to process and quality information, thereby aiding in the enhancement of production workflows from the initial order stage to the final product. Ultimately, this solution not only improves operational efficiency but also supports compliance with stringent industry regulations.

The DeltaV S-series Electronic Marshalling utilizing CHARMs allows for flexible placement of field cabling, independent of the type of signal or control methodology employed. The DeltaV™ Distributed Control System (DCS) is designed to streamline automation processes, which reduces operational challenges and mitigates project risks effectively. This advanced collection of products and services enhances plant efficiency through intuitive control solutions that are straightforward to manage and service. Importantly, the DeltaV DCS is adaptable, easily scaling to fit your specific requirements without introducing additional complexity. Furthermore, the seamless integration capabilities of the DeltaV system encompass various functions including batch processing, advanced control, change management, engineering tools, diagnostics, and much more, ensuring a comprehensive solution for your operational needs. Ultimately, this flexibility and integration pave the way for improved productivity and reliability in industrial environments.

Laurel MES is a cloud-based platform designed specifically by production engineers to streamline operations in manufacturing facilities, ensuring consistent and accurate batch production. This comprehensive system allows users to drive, assign, manage, and oversee all manufacturing processes from a single dashboard. Covering every stage of the manufacturing lifecycle—from initial production to final packaging—Laurel MES is compatible with various types of Pharma and Chemical Product Manufacturing. By offering integrated solutions that enhance value and minimize errors, Laurel MES effectively serves all production lines within the Pharma and Chemical sectors. The system has been designed to fully replace traditional manual batch records with electronic versions that mirror the appearance of physical manufacturing records, thus facilitating a smoother transition to digital documentation. This innovative approach not only boosts efficiency but also promotes better compliance with industry regulations.

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 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.

POMS consistently invests in research and development for its manufacturing execution system (MES), resulting in a solution that is adaptable, user-friendly, and does not necessitate any customization. Remarkably, all of our clients currently operate without any tailored solutions! POMSnet Aquila is a web-oriented MES specifically designed for the Life Sciences sector, built using Microsoft .NET and HTML5 technologies. The entirely web-based platform offers an intuitive interface that is both easy to learn and cost-effective to deploy and maintain. POMSnet Aquila encompasses a range of functionalities, including management of recipes and specifications, materials oversight, equipment tracking, production order control, recipe execution, electronic batch records, and device history. Moreover, POMSnet integrates industry best practices and business logic tailored for Pharmaceutical Manufacturing Execution Systems, ensuring optimal operational efficiency and compliance. By continually evolving its offerings, POMS demonstrates its commitment to meeting the dynamic needs of the Life Sciences industry.

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.

Empower your team by providing them with the ability to create intuitive, no-code procedures and recipes specifically designed for process scientists and engineers, enabling them to customize Tempo effortlessly. Tempo facilitates collaborative recipe authoring in real-time, allowing users from your organization and even CDMO clients to edit together using innovative group-editing features. With Tempo, users can swiftly design intelligent workflows that incorporate advanced functionalities such as parallel execution, branching, and enforcement logic, all while integrating key components like referenceable parameters, formulas, equipment, materials, and operator actions, without writing any code. Additionally, any team member can enhance procedural steps with augmented guidance, including images, videos, and AR overlays. The platform includes a native mobile application and supports hands-free, voice-activated headsets, making it versatile for use in various settings, including laboratories, cleanrooms, and during the use of personal protective equipment. This seamless integration ensures that teams can maintain productivity and collaboration regardless of their physical environment.

Designed specifically for pharmaceutical and other GxP-compliant organizations, this solution streamlines the digitization of manufacturing processes, quality control, and regulatory compliance. By allowing data to guide decisions, teams can promptly respond to real-time events, enhancing performance and addressing quality challenges as they arise. Equip operators with an intuitive tool that empowers them to achieve accuracy on their first attempt. The intricacies of manufacturing become even more daunting when GMP regulations are factored in, but by equipping your teams with the appropriate tools, you can tackle major challenges and attain significant improvements. This approach drastically cuts down the time and effort involved in batch review and approval by utilizing review-by-exception, eliminating the need to examine entire batch records. Furthermore, it automates inefficient tasks, such as the manual entry and verification of data, transferring paper documents around the production area, and managing calculations and workflows, ultimately enhancing operational efficiency and productivity. In this way, companies can foster a more streamlined and effective manufacturing environment.