Alternatives to AmpleLogic eBMR

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

Designed specifically for pharmaceutical and other GxP-compliant organizations, this solution streamlines the digitization of production, quality, and compliance processes within manufacturing operations. Empower your data to guide decisions effectively. With real-time event monitoring, teams can swiftly respond to performance issues and tackle quality challenges as they arise. Equip operators with a user-friendly tool that enhances their ability to achieve accuracy on the first attempt. Navigating the complexities of manufacturing is challenging, especially with the added layer of GMP regulations. By providing your teams with the appropriate resources, you can address critical issues and unlock transformative advancements. Significantly cut down on the time and effort needed for batch reviews and approvals through a review-by-exception approach, eliminating the need for exhaustive reviews of complete batch records. Furthermore, automate tedious tasks such as data input and verification, managing paper records across the production floor, carrying out and double-checking calculations, and overseeing workflows, among others. This not only enhances efficiency but also allows teams to focus on more strategic initiatives.

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.

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

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.

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.

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.

AmpleLogic's AI-based APQR software provides a revolutionary solution for generating precise Product Quality Review (PQR) and CPV reports that meet the stringent requirements of current Good Manufacturing Practices (CGMP) regulations (21 CFR 211.180(e)). By utilizing OCR for data extraction and integrating AI-driven chatbot technology, this software significantly speeds up the document data extraction process and provides faster access to critical information. As a result, businesses can improve audit preparedness, ensure timely regulatory submissions, and streamline their operational workflows to maintain compliance and efficiency.

AmpleLogic's Learning Management System (LMS) effectively streamlines and oversees a wide array of GMP and Non-GMP training within the life sciences sector, particularly for pharmaceutical manufacturing, API manufacturers, contract development and manufacturing organizations (CDMOs), biotechnology firms, and contract research organizations (CROs), encompassing training on SOPs, technical skills, human resources, external matters, and research initiatives. Furthermore, the AmpleLogic Pharmaceutical Training Management Software facilitates the identification of training needs based on an individual's specific role, allows for the development of training calendars tailored to particular departments, and supports the execution and evaluation of diverse employee training programs, ensuring compliance through meticulous tracking and maintaining annual training records, alongside generating reports for management oversight. This comprehensive approach not only enhances training efficacy but also fosters a culture of continuous improvement within organizations.

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.

AmpleLogic EDMS Software serves as a robust electronic document management solution tailored specifically for the Pharmaceutical and Biotech sectors, crafted to address the stringent cGMP requirements of the Pharma industry while ensuring compliance with both 21CFR Part 11 and EU Annex 11, effectively resolving the myriad challenges encountered by various organizations. This paperless document management system allows users to seamlessly manage and interact with all types of documents and information with ease. Key functionalities of the AmpleLogic Document Management System include document creation, review, approval, editing, document comparison, version control, and the ability to conduct parallel reviews, all designed to enhance operational efficiency and compliance. By integrating these features, AmpleLogic EDMS not only streamlines workflows but also significantly reduces the risk of errors in document handling.

Empower your team by enabling them to take control of their processes. With user-friendly, no-code tools for procedure and recipe creation tailored for process scientists and engineers, your team can effortlessly configure Tempo without any coding expertise. Tempo facilitates real-time collaboration, allowing users from your company, as well as partners and customers from CDMO, to co-author recipes using live group-editing features. Users can swiftly design sophisticated workflows that incorporate advanced functionalities such as parallel execution, branching, and enforcement logic, along with the ability to integrate referenceable parameters, formulas, equipment, materials, and operator actions, all without writing any code. Additionally, any user can enhance procedures by incorporating augmented guidance, including photos, videos, and AR overlays, into any procedural step. Our mobile application and voice-activated headset are designed to accompany you wherever you go, ensuring usability in various settings – from suites and cleanrooms to environments where personal protective equipment is worn. This versatility allows teams to maintain productivity and efficiency, regardless of the circumstances.

The AmpleLogic Regulatory Information Tracker is designed using a LOW CODE AND NO CODE (LCNC) PLATFORM and features two primary modules: the ANDA Tracker and the DMF Tracker. This innovative Pharmaceutical RIMS Software enhances data quality, increases operational efficiency, reduces errors, and facilitates smoother communication between various departments, ultimately contributing to a more effective regulatory management process. By implementing this tool, organizations can achieve a higher level of compliance and stay ahead in the competitive pharmaceutical landscape.

Process XE by Sarjen Systems is a powerful Manufacturing Process Automation solution tailored for the pharmaceutical industry, serving as a full-featured Manufacturing Execution System (MES). It enhances shop floor visibility, control, and efficiency by automating key processes such as batch production, packaging, and equipment management. The platform captures real-time data in strict adherence to ALCOA+ principles and meets 21 CFR Part 11 regulatory compliance requirements. Its standout features include electronic batch records (eBMR/eBPR) for streamlined documentation, robust weighing and dispensing management systems (WDMS), and comprehensive digital logbooks to replace paper records. Process XE supports a paperless manufacturing environment, facilitating audit readiness and improving operational transparency. By providing end-to-end traceability and ensuring data integrity, it helps pharmaceutical manufacturers optimize quality and compliance. The system’s real-time monitoring and control tools enable swift decision-making on the shop floor. Sarjen Systems’ Process XE is ideal for pharma companies looking to digitize and modernize their manufacturing operations.

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.

SG Systems Global offers traceability and manufacturing solutions for regulated and non-regulated industries, integrating with ERP and MES platforms to boost efficiency and ensure product quality. Key Modules: * Electronic Batch Records (EBRs): Digital records to meet 21 CFR Part 11 and GMP compliance, reducing manual errors. * Formula Control: Ensures accurate ingredient measurement and consistency across batches. * Batch Control: Tracks production in real time, enabling lot validation and recall management. * Warehouse Management System (WMS): Manages inventory with barcode scanning and real-time stock updates. * Production Scheduling: Automates workflows, assigns tasks, and generates performance reports. These solutions streamline processes, enhance compliance, and support scalable growth for manufacturers.

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.

CaliWare360 is a cloud-based Warehouse Management System (WMS) tailored specifically for the pharmaceutical sector, aimed at boosting operational efficiency. This system offers real-time inventory oversight, accurate material handling, and automated workflows designed to enhance warehouse performance. Key features encompass barcode and RFID integration, as well as FIFO and FEFO management, all of which aid in the organization and monitoring of inventory. Furthermore, the platform ensures adherence to Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) by providing reliable traceability and comprehensive audit trails. It also integrates effortlessly with Electronic Batch Records (EBRs) and various manufacturing systems to streamline material handling. The presence of customizable dashboards and checklists fosters improved visibility and efficiency within warehouse operations. In addition, CaliWare360 is scalable, making it an excellent fit for businesses experiencing growth, while it simultaneously enhances retrieval efficiency and minimizes handling times, helping organizations thrive in a competitive market. With its innovative approach, CaliWare360 redefines how pharmaceutical warehouses manage their operations.

A standardized procedure for the management of investigational agents is essential to enhance patient safety while ensuring adherence to regulatory requirements. This process includes implementing safeguards to avoid the selection of expired or quarantined agents during dispensing, thereby reducing the chance of providing medication to patients not participating in a study. It is crucial to meticulously capture all dispensing details and document them in the Drug Accountability Record Form (DARF). Additionally, measures should be taken to prevent the distribution of drugs that may expire within the treatment period by thoroughly assessing the dispense date, available supply, and expiration date. Tracking details such as drug thaw time, reconstitution time, and temperature readings at the time of reconstitution is also vital. The centralized electronic management of investigational agents enhances clarity, minimizes paperwork and handwriting errors, and simplifies inventory management, allowing pharmacists to dedicate more time to critical tasks and patient care. Furthermore, while DARFs can be tailored using various filters, they still maintain a uniform appearance across all protocols, regardless of the sponsor involved, ensuring consistency and ease of use for all parties. This comprehensive approach to managing investigational agents ultimately contributes to a safer and more efficient clinical trial environment.

MSLInsight is a cloud-oriented solution crafted for managing interactions with Key Opinion Leaders (KOLs), specifically aimed at emerging life sciences firms within the pharmaceutical, biotechnology, medical device, and diagnostics industries. By consolidating KOL insights into a single platform, it empowers Medical Science Liaisons (MSLs) to enhance their efficiency and streamline their interaction management. The platform features a real-time dashboard that tracks KOL interaction metrics while ensuring adherence to regulatory standards. MSLInsight optimizes workflows through seamless data integration and mobile accessibility, allowing MSLs to capture, report, and analyze interactions from the outset. Additionally, it fosters increased product awareness and uptake by promoting the exchange of information between companies and the healthcare community, thereby supporting efforts on local, national, and international scales. Built on the Salesforce framework, this software is user-friendly and straightforward to implement, making it a cost-effective choice for organizations seeking to maximize their KOL engagement strategies. Furthermore, the platform's comprehensive capabilities position it as an essential tool for life sciences companies aiming to elevate their market presence and establish meaningful connections within the medical field.

Labbit LIMS was specifically developed to accommodate the growing intricacies and rapid advancements in testing, scientific research, and product development across diverse sectors such as biotechnology, clinical diagnostics, pharmaceuticals, and manufacturing, among others. By adopting a contemporary methodology, it significantly reduces the time required for implementation, enhances workflows, and captures intricately linked data in unalterable records to promote innovation while ensuring compliance with regulatory standards is straightforward. Unlike traditional laboratory informatics systems, which often impose a one-size-fits-all model on lab operations, Labbit LIMS allows for a tailored approach that mirrors your specific workflows, thereby boosting efficiency and precision. This comprehensive laboratory informatics platform offers real-time insights and complete data accessibility, ensuring that users always have the information they need at their fingertips. Furthermore, its adaptable, cloud-based architecture is designed to easily accommodate evolving requirements and enhance overall productivity, making it a vital tool for modern laboratories. By leveraging this flexibility, organizations can stay ahead in a competitive landscape and meet the demands of innovation seamlessly.

Mareana, a cloud-based Enterprise AI Platform, connects siloed data in manufacturing and enables contextualization, processing and predictive analytics in real-time to drive insightful business decision. Mareana Manufacturing Intelligence is a powerful tool that helps small, large, and medium-sized enterprises increase yield, unlock capital, and comply with regulatory requirements. The Mareana Intelligence Platform offers the following benefits: - Connect your data in one place, such as paper batch records, CMO process data, and unstructured data - Create Product Generatives in Real-Time, and get Granular Product Details, Process Anomalies and Variations, as well as New Data Impact Analytics - Unlock Capital by releasing On Hold Batches, Improving yield, and reducing Up-stream/Down-stream Non-Conformances - Execute Compliance Files Flawlessly, by ensuring full reporting, leveraging data sources and reducing errors. Three of the top ten pharmaceutical companies in the US use Mareana's platform for CPV & CMC.

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

Slingshot Pharma offers a comprehensive inventory management solution tailored specifically for pharmaceutical manufacturers seeking cGMP compliance. With real-time tracking capabilities, the software ensures precise inventory accuracy and regulatory adherence throughout the manufacturing process. It helps organizations optimize their stock levels, minimize waste, and increase operational efficiency. The system’s scalable architecture supports businesses of various sizes and adapts to evolving industry standards. Designed to keep pharmaceutical operations audit-ready, Slingshot Pharma streamlines workflows and simplifies compliance reporting. Its robust technology integrates seamlessly into existing manufacturing environments. This allows manufacturers to maintain control and visibility over their inventory at all times. Slingshot Pharma empowers companies to meet stringent regulatory demands while driving productivity.

AmpleLogic's Quality Management Software, known as eQMS, is meticulously designed to fulfill the stringent demands of industries that face heavy regulation. This ISO 9001 certified cloud-based Quality Management System (QMS) is particularly suited for sectors such as Life Sciences, Food & Beverages (F&B), Cosmetics, Medical Devices, Gene Therapy, and similar fields. With the growing recognition of the difficulties tied to manual quality inspections—which can be both tedious and error-prone—more businesses are turning to QMS software solutions. These advanced systems significantly improve audit quality by automating processes, managing data effectively, and allowing for smooth API integration, ultimately fostering a more reliable quality assurance environment. This shift not only streamlines operations but also enhances compliance with industry standards.

Orbit Pharmaceutical Suite is a comprehensive cloud-based business management solution designed specifically for pharmaceutical manufacturers, built on the robust Oracle platform. This all-in-one software integrates various departments, including Administration, Raw Material Storage, Production, Accounting, Quality Control, Human Resources, Sales, Marketing, Distribution, and IT, streamlining operations across the board. By reducing operational costs and saving valuable time, it enhances decision-making capabilities, as managers gain access to real-time and accurate information through a unified data framework. The system offers extensive reporting, efficient workflows, and online real-time functionalities, leading to increased operational effectiveness and productivity. Additionally, it provides timely feedback for informed decision support, improves customer service, and enhances batch tracking management. Over a decade of collaboration with diverse pharmaceutical business models has refined this solution, establishing a proven track record of delivering ERP projects successfully and on schedule, ensuring that clients can rely on its capabilities. With continuous improvements and updates, the suite remains adaptable to the evolving needs of the industry.

Werum's PAS-X offers a well-established software solution tailored for the highly regulated and batch-focused process industries. This MES delivers comprehensive built-in functionality for various applications within the pharmaceutical and biopharmaceutical domains. Organizations that utilize PAS-X experience enhanced operational efficiency and streamlined production processes. The software encompasses all essential features necessary for effective pharmaceutical and biopharmaceutical manufacturing right from the start. Meeting the stringent requirements of regulatory bodies, including the FDA, PAS-X ensures compliance and safety. Furthermore, its extensive array of standard interfaces facilitates quicker implementation and promotes smooth data exchange with adjacent IT and production systems. The PAS-X MES caters to all significant segments of the pharmaceutical industry, including the production of vaccines, biopharmaceuticals, solids, and liquids, among other manufacturing activities. Ultimately, PAS-X empowers companies to achieve their operational goals while adhering to industry standards and regulations.

Enhance study efficiency, ensure regulatory compliance, and prioritize patient safety with Alpha Clinical Systems' electronic drug inventory management system (DIMS). By minimizing site errors and decreasing workload, you can achieve real-time transparency in your operations. The comprehensive web-based system, ez-DIMS, optimizes drug and device distributions at the site, effectively eliminating transcription mistakes. With seamless integration to ex-SourceDocx, it automatically tracks supply disbursements, offering instant visibility of the drug inventory. Transition from cumbersome and error-prone manual processes to the intuitive ez-DIMS platform. Furthermore, site workloads can be alleviated through user-friendly scanners that swiftly and accurately log study supply inventory and accountability across patient, site, and study categories. Notably, drug inventory violations at clinical sites rank as the second most frequent finding during regulatory inspections. By utilizing QC cross-checks between ez-DIMS and ez-SourceDocx, you can significantly decrease medication assignment and dispensation errors, enhancing overall compliance and safety protocols. This transformation not only supports effective management but also fosters a safer environment for patient care.

Nova-LIMS has transformed laboratories by minimizing manual tasks and saving time, which has allowed pharmaceutical and biotechnology companies to accomplish goals such as reducing the time it takes to bring products to market while maintaining regulatory compliance. Over time, the need for system integration and automation has grown significantly, positioning Nova-LIMS as a leader in harmonizing processes and centralizing data. This platform fosters accountability and trust among interconnected departments, creating a cohesive environment for the entire organization and its clients through streamlined laboratory testing, scheduling, data collection, and real-time reporting. A standout feature of Nova-LIMS is its ability to facilitate smooth communication between Laboratory Information Management Systems and Quality Management Systems. Additionally, Nova-LIMS is a versatile, ready-to-use laboratory information management software solution that can be easily customized to fit your unique needs, ensuring that it meets the diverse demands of each laboratory efficiently. This adaptability makes Nova-LIMS an essential tool for laboratories looking to enhance their operational efficiency and effectiveness.

Tailor and Enhance Your Peer Review Workflow for Code and Documents Using Collaborator. Recognized as the leading tool for peer review of code and documentation, Collaborator is designed for development teams committed to maintaining high software quality. Its extensive review capabilities allow you to evaluate source code, design documents, requirements, user stories, test plans, and other documentation all within a single platform. To ensure accountability, it offers proof of review through electronic signatures and comprehensive reports that help meet regulatory compliance requirements. It supports a wide variety of Source Code Management (SCM) systems, including Git, SVN, TFS, Perforce, CVS, ClearCase, RTC, and more. Collaborator also seamlessly integrates with popular platforms such as GitHub, GitLab, Bitbucket, Jira, Eclipse, Visual Studio, among others. Additionally, real-time updates and threaded chat facilitate ongoing discussions, highlighting changes and defects to enhance visibility during each review. Recognizing that every team and project has its distinct needs, Collaborator provides customizable review templates and checklists to create tailored peer review frameworks that suit specific requirements, ensuring that your review process is as effective and efficient as possible. This flexibility empowers teams to adopt best practices tailored to their individual workflows.

CBO ERP Ltd stands out as a premier provider of tailored, process-oriented software solutions specifically designed for the pharmaceutical sector. At the core of their offerings is a versatile 6-in-1 ERP system that can be customized to help pharmaceutical firms manage critical operations such as production, distribution, financial management, web-based reporting, mobile and tablet accessibility, as well as online human resources and payroll functions. This ERP solution is engineered to function seamlessly both online and offline, granting users comprehensive control under any circumstances. In the realm of pharmaceuticals, accuracy is paramount; even a minor error can jeopardize lives, making reliability essential for businesses that customers depend upon for their health. Given the volatile nature of the market, many companies are actively seeking ways to optimize their financial operations and implement more effective financial strategies. Additionally, eCommerce, which encompasses the buying and selling of goods, services, or products via the internet, is also commonly referred to as electronic commerce or internet commerce. This evolution in commerce has further emphasized the need for robust software solutions that can enhance operational efficiency.

CaliberPulse is an advanced analytical platform specifically designed for the pharmaceutical sector, aimed at converting intricate data into practical insights that enhance efficiency and ensure compliance in quality assurance and manufacturing processes. This platform boasts integrated reporting capabilities that deliver immediate insights into statistical process control and quality metrics, specifically catering to the requirements of the pharmaceutical field. By effortlessly integrating with applications such as MS Excel, LIMS, EBR, and SAP, it allows for streamlined data extraction and real-time reporting while minimizing the need for manual input. Additionally, CaliberPulse features sophisticated tools like automated Box-Cox data transformation, critical attribute assessments, and comprehensive data visualization options that render results in a user-friendly format through graphical representations and color-coded interfaces. Furthermore, the system guarantees adherence to regulatory requirements by automating the processes of data ingestion and storage, while maintaining complete traceability throughout. Ultimately, CaliberPulse empowers pharmaceutical organizations to make data-driven decisions with confidence and precision.

Vimachem’s Pharma 4.0 MES platform stands out as a versatile and entirely modular manufacturing execution system, leveraging the principles of AI and IIoT to facilitate digital transformation in the pharmaceutical and biopharmaceutical sectors. Tailored for environments adhering to cGMP regulations and 21 CFR Part 11 standards, this system provides instantaneous, contextually relevant feedback on the production floor, effectively linking devices, machinery, and personnel to streamline operations from the initial planning stages to the final product delivery, all while upholding strict quality requirements. The platform ensures that information circulates effortlessly throughout the organization, supplying the appropriate data to the relevant teams precisely when needed. By utilizing AI-generated insights, it enhances production efficiency and overall equipment effectiveness (OEE) from the outset, while secure integrations consolidate all plant data into user-friendly dashboards. With the elimination of paperwork, the prevention of compliance issues, and the facilitation of scalable automation, Vimachem enables life-science manufacturers to minimize manual labor, elevate operational performance, and expedite the introduction of essential therapies to the market. Ultimately, this innovative solution not only propels efficiency but also supports the evolving needs of the pharmaceutical industry.

RxConnect is an innovative web-based pharmacy solution tailored to address the medication dispensing requirements of inpatient hospitals. With its user-friendly interface, healthcare providers can conveniently submit pharmacy orders directly through their electronic health records (EHR), establishing a direct electronic link between order placement and pharmacy services for efficient medication delivery. The platform enhances dispensing functionalities through integration with automated dispensing machines (ADMs) and interfaces with the electronic medication administration record (eMAR), ensuring a comprehensive closed-loop medication management system. Clinicians have the ability to assess and oversee potential drug interactions, allergies, and patient-specific dosing adjustments with the aid of a clinical rules engine. Furthermore, it provides crucial information on drug disease interactions, alcohol use, laboratory results, and essential precautions regarding pregnancy, lactation, and black box warnings. In addition, RxConnect encompasses features such as inventory management, formulary tracking, progress notes, laboratory integration, intervention documentation, and pharmacy notes, thereby creating a holistic approach to medication management within the hospital setting. This comprehensive suite of functionalities not only streamlines the medication process but also enhances patient safety and clinical efficiency.

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.