Alternatives to MyCellHub
Compare MyCellHub alternatives for your business or organization using the curated list below. SourceForge ranks the best alternatives to MyCellHub in 2026. Compare features, ratings, user reviews, pricing, and more from MyCellHub competitors and alternatives in order to make an informed decision for your business.
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Propel
Propel Software
Propel is a cloud-native platform that unifies PLM, QMS, and PIM in one connected system, giving manufacturers complete visibility and control across the entire product lifecycle. It provides a single source of truth for product data, streamlines change management, strengthens quality and compliance, and accelerates time-to-market by eliminating silos. With real-world AI use cases and enterprise-grade security, Propel helps organizations reduce errors and improve cross-functional alignment. Agentic AI accelerates change reviews, surfaces BOM and quality risks, enriches product information, and guides decisions—while role-based permissions and audit trails protect IP. From design through manufacturing and commercialization, Propel empowers companies to deliver innovative, high-quality products faster with greater confidence. Each module deploys independently with no required dependencies. -
2
AlisQI
AlisQI
AlisQI is a modular, cloud-based Quality Management platform for process and batch manufacturers who want to reduce firefighting, improve predictability, and stay compliant by default. Unlike traditional EQMS platforms that were built around documents and later adapted for analytics, AlisQI was designed from the start as a data-first system. Quality, lab, and production data are structured and connected in one operational backbone. That foundation now enables practical AI capabilities inside daily workflows. Manufacturers can automatically extract data from diverse supplier COAs without predefined templates, generate structured digital forms from existing files or plain language, query their QMS conversationally, and detect recurring incident patterns across sites. Core modules include Document Control, Training, Deviations, CAPA, Audits, Risk Management, Supplier Quality, SPC, and EHS, supported by targeted out-of-the-box Solvers that address specific operational problems. -
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Lockbox LIMS
Third Wave Analytics
A sample tracking, test result capture, and inventory management cloud LIMS for life science research, biotech/NGS, and industrial QC labs. Includes regulatory support for CLIA, HIPAA, Part 11, and ISO 17025. Nothing is more critical to a lab’s success than the quality, security, and traceability of samples. The Lockbox LIMS system provides robust sample management functionality to laboratory professionals, giving them full visibility on every aspect of a sample’s journey, from accessioning to long-term storage. LIMS analysis is about more than just tracking results- Lockbox’s multi-layered sample storage and location management functionality allows you to define your lab’s storage framework using a variety of location options: rooms, storage units, shelves, racks, boxes, and positions. -
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Aizon
Aizon
Aizon: Intelligent GxP Manufacturing Aizon enables pharmaceutical and biotech manufacturers to transform operations with AI-powered solutions purpose-built for GxP environments. Our platform helps reduce variability, increase yield, and ensure product quality—consistently and at scale. Aizon Execute — Intelligent Batch Record (iBR): Digitize manufacturing in weeks, not months, reducing deviations and accelerating batch release. Aizon Unify — Contextualized Intelligent Lakehouse: Integrate and contextualize data across systems and sites to drive actionable insights for manufacturing excellence. Aizon Predict — GxP AI Industrialization: Deploy predictive AI to optimize critical process parameters, improve Right-First-Time rates, and boost yield. With Aizon, manufacturers move beyond compliance to achieve operational intelligence—analyzing the past, mastering the present, and shaping the future of production. -
5
Dot Compliance QMS
QMS for Life Sciences
Dot Compliance provides the industry’s first off-the-shelf QMS solution – ready to deploy from day one, with little to no setup required, while also incorporating industry best practices and standards that address the latest global regulatory requirements. Powered by the Salesforce.com platform, our solutions enable life science organizations to quickly digitize their quality and compliance processes including Document Management, Training Management, Change Control, CAPA, Customer Complaints. Compliant with 21 CFR part 11, EU-Annex 11 and support ISO 9001, 13485, 14971, 27001 & MORE! Processes included: ▶ Document Management ▶ Training Management ▶ Quality Event Management ▶ CAPA Management ▶ Change Management ▶ Complaint Management ▶ Audit Management ▶ Supplier Quality Management ▶ Risk Management ▶ Design Control ▶ Deviations/Non-conformances ✔ Seamless Install ✔ Cost Effective ✔ One-Stop-ShopStarting Price: $10,000 / Annually -
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SimplerQMS
SimplerQMS
SimplerQMS offers a cloud-based Quality Management Software that is fully validated according to GAMP5 and specifically designed for the Life Science industry. This comprehensive QMS platform helps ensure compliance with various regulatory requirements, including FDA 21 CFR Part 11, EU Annex 11, GxP, cGMP, GAMP 5, GDPR, EU IVDR & EU MDR, ISO 13485:2016, 21 CFR Part 820, ICH Q10, and others. The software offers a wide range of Life Science QMS modules, such as Document Control, Change Management, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, Quality KPIs, among others, ensuring a seamless experience. SimplerQMS enhances document handling by allowing users to work directly in Microsoft Office applications like Word, PowerPoint, and Excel.Starting Price: $13,750/year -
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QT9 QMS
QT9 Software
Struggling with complex compliance requirements or disconnected quality systems? QT9 QMS eliminates these challenges with one integrated, fully validated platform that scales with your business. Designed for life sciences, aerospace, and manufacturing, QT9 offers cloud or secure on-premise deployment to meet your needs. Stay audit-ready automatically with built-in FDA, ISO, and EU MDR compliance while reducing manual work by up to 70%. With 28+ modules included—like document control, CAPA, training, and supplier management—QT9 deploys fast without costly customization. Backed by ISO 27001 certification, unlimited support, and 20+ years of proven success, QT9 helps 1,100+ organizations accelerate compliance, improve visibility, and simplify quality management. Start your free trial or book a personalized demo today.Starting Price: $10,000/year -
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LABTRACK LIMS
LABTRACK
While most LIMS systems take a year or more to implement – the LABTRACK LIMS can be up and running in your laboratory in just a few days or weeks. Its simple, intuitive design and the built-in Forms Definition, Menu Customization Module, and Custom Reporting Tool make it a breeze to implement. The included standard LIMS modules addresses the most commonly needed functions including: Batch and Sample Login Bar code entry and printing Custom Data Entry (useful for managing inventory, training records, specifications, etc.) Test and Test-Group Scheduling Login Approval Single Request Results Entry Multiple Request/Test Results Entry Automatic Spec Checking/Flagging Lab Management Approval Sample Disposition Sample Location Management Test Assignment QA Approval Reports User Account Management User Role Management And our optional Stability Study Management option adds the calendaring/scheduling functionality needed for accelerated and standard shelf life testing.Starting Price: $240 per user per month -
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Intellect
Intellect
Intellect QMS is the latest version of Intellect's flagship product designed to help organizations and quality leaders meet FDA, ISO, and other global GxP regulatory compliance requirements. Intellect offers faster implementation time, robust out-of-the-box QMS capabilities, and extreme configurability to modify or build new apps. Empower your onsite and remote workforce with virtual auditing, online approvals, 21 CFR Part 11 electronic signatures, and ensure your team can access only approved and up-to-date quality documents, data, reports and analytics anytime, on any device. Intellect’s Environmental, health, safety and quality (EHSQ) software acts as a data management system for capturing, storing, and analyzing information related to occupational health and safety, waste management, and sustainability. It aims at reducing operational risk and improving health while attaining sustainability goals. -
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MasterControl
MasterControl
Bringing breakthrough products to market in highly regulated industries can feel like an endless series of trade-offs. MasterControl's software simplifies GxP workflows so you never have to sacrifice quality for cost or innovation for regulation. Complete and connected meets fast and flexible. From quality event management to document control and integrated training - MasterControl Quality Excellence transforms your quality data and processes into a competitive advantage. Modernizing your manufacturing operations starts with modern software. From work orders to work instructions and production records (EBR or eDHR) to logbooks, MasterControl Manufacturing Excellence is the simplest way to digitalize manufacturing.Starting Price: $25,000 / 1st year -
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DELMIAworks
Dassault Systemes
Combine manufacturing, MES, supply chain, and ERP software to optimize your shop floor. Learn how DELMIAworks (formerly IQMS) can help increase visibility into every aspect of your manufacturing operation and solve your most trying production challenges. Prevent unnecessary downtime, while increasing manufacturing efficiency, quality, and profit margins. Improve decision making with real-time access to data across the entire supply chain. A single system for all ERP, manufacturing, MES, and supply chain requirements. Lower your overall cost of investment and maintenance by automating your business. Our easy-to-use solution can help you double plant output, eliminate human errors, and increase the efficiency of your production planning process. Manage, track and monitor the complete production process to eliminate unplanned downtime and increase throughput. OEE charts and graphs are dynamically updated with performance and quality data in real-time. -
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Validfor
Validfor
Validfor is a secure, modular digital validation platform that centralizes the entire validation lifecycle on a single, paperless system. Designed specifically for regulated industries, Validfor enables efficient validation while ensuring full compliance with GAMP 5, 21 CFR Part 11, and EU Annex 11. The platform supports electronic records and advanced electronic signatures with full audit trails, role-based workflows (Author, Reviewer, Approver), and complete CSV compliance. All documents and records are securely managed in a centralized repository, capturing every change with full traceability to protect data integrity and Quality Assurance. Validfor offers integrated modules for Change Management, Deviations, Testing, and Periodic Reviews, enabling seamless impact assessments, CAPA tracking, Computer Software Assurance (CSA), and audit-ready lifecycle management. -
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BatchLine
BatchLine
Purpose-built for Pharma and other GxP-regulated companies to digitize production, quality, and compliance for manufacturing operations. Let the data do the talking. Teams take actions from real-time event monitoring into performance, track and solve quality issues as they happen. Give operators a tool that's easy to use and helps them get it right first time. Manufacturing is a complex business, add in GMP regulations and it gets significantly more so. Providing your teams the right tools is an opportunity to solve significant problems and realise transformational improvement. Vastly reduce time and effort for batch review and approval through review-by-exception, no more reviewing entire batch records. Automate wasteful activities like manually inputting and verifying data, moving paper records around the shop floor, performing and checking calculations, workflow management and more. -
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Alpha Technologies Enterprise
Alpha Technologies
Reliability, Quality assessment and Data management, making sure your process is running optimally and the collected data is used for defining your quality control, designing your next product, and providing accurate and reliable data to the end-user. When you run multiple test samples of one compound, it’s important that your instrument consistently returns the same results within specification. With a wide variety of polymers and compounds used to meet today’s demanding specifications, it’s vital that your instruments have the ability to detect minor variations in a sample. Properly installed and maintained Alpha instruments will consistently reproduce precise and actionable data whether you have several rheometers in a single lab or in a number of facilities worldwide. As the world leader in the design and manufacturing of instruments and software, Alpha delivers advanced precision rubber and elastomeric materials analysis for production optimization. -
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Qualis LIMS
Agaram Technologies
Qualis LIMS is an enterprise-class laboratory information management system used in industrial, analytical, & commercial sample testing across several industry verticals such as pharmaceutical, life-sciences, contract research, clinical research etc. Qualis LIMS has built-in integrated modules to manage all laboratory processes & help labs perform their tasks in an automated and paperless manner while enabling them to fulfil regulatory compliance requirements & adhere to industry standards. It digitally transforms labs by helping them: • In managing, storing, & aliquoting of samples. • Record final results of tests & experiments - manage tests, projects, samples, instruments & inventory in one central secure database. • Meet data integrity & regulatory compliance requirements such as GxP, ISO17025, 21 CFR Part 11 & EudraLex Annex 11 without any compromises. -
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Opcenter Execution Process
Siemens Digital Industries Software
Manufacturing Execution System capabilities include vertical integration, process orchestration, genealogy, and production reporting covering wall-to-wall manufacturing processes such as material receiving, production, and material outbound. Integrated quality management handles sampling, analysis, and evaluation of quality results seamlessly tied to the manufacturing events. Using Opcenter Execution Process as a mom platform enables seamless integration with scheduling, quality, and manufacturing intelligence, which delivers interactive dashboards for analysis of production data. For new product development & introduction, Opcenter Execution Process enables the transformation of recipes from “generic” specifications to detailed “master” instructions, ready for order scheduling and execution. -
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LabHQ LIMS
Broughton Software
LabHQ is a cloud-based LIMS built for quality control testing and manufacturing labs. Manage samples, test methods, specifications, results, and documentation all in one platform - with a defined workflow from job submission through to verification, approval, and reporting. Built by a team with decades of GxP and QC experience, LabHQ includes full audit trail, e-signatures, MFA, OOS monitoring, role-based permissions, and version-controlled updates - supporting both regulated and non-regulated environments including pharma, food & beverage, environmental, contract testing, and manufacturing. Key features include sample turnaround tracking, equipment management, stock management, certificate of analysis generation, trend analysis, and an external user portal for client access.Starting Price: £100/$135 /user/month -
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Vimachem
Vimachem
Vimachem’s Pharma 4.0 MES platform is a flexible, fully modular manufacturing execution system built on AI and IIoT principles to drive digital transformation in pharmaceutical and biopharmaceutical production. Designed for cGMP environments and 21 CFR Part 11 compliance, it delivers real‑time contextualized feedback on the shop floor, connecting devices, equipment, and operators to accelerate processes from planning to product delivery while maintaining rigorous quality standards. It ensures information flows seamlessly across the enterprise, delivering the right data to the right teams at the right time. AI‑driven insights optimize production efficiency and OEE from day one, while secure integrations unify all plant data into intuitive dashboards. By eliminating paperwork, preventing compliance lapses, and enabling scalable automation, Vimachem empowers life‑science manufacturers to reduce manual effort, boost operational excellence, and bring critical therapies to market faster. -
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Cosmino MES Plus
COSMINO
Cosmino Manufacturing Execution System intensifies collaboration between people, operating equipment and IT making the digital factory an intelligent (smart) factory. Cosmino MES Plus creates transparency and increases quality and efficiency in production. Manual management effort for production orders will be reduced by half. MES will make a large numbers of variations and flexible access behavior feasible. The Zero Defects strategy (ZD) can be completely ensured all the way to the customer. The Traceability feature is also a precious assurance when a recall must be made. Statistical quality sampling and comparison of the control cards using intervention limits and process capability (CpK) will be done reliably using Cosmino MES Plus. Integrated test planning will also provide support. If the values do not fit the tolerances, the software will propose measures to ensure Quality. Using the Traceability feature will add additional information such as materials and preliminary products. -
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Veeva Vault QualityDocs
Veeva Systems
Providing automated workflows and comprehensive audit trails, Vault QualityDocs reduces compliance risk and improves quality processes. It accelerates review and approval processes and facilitates the sharing of SOPs and other GxP documents among employees and partners. Automated workflows and visibility into the content status and processes enable effective SOP management, reducing compliance risk. Intuitive, easy-to-use user interface drives adoption and efficiency. Detailed audit trails, content organization, and powerful search facilitate better audits and inspections. Securely access and use documents from any major web browser, or if enabled, print, distribute, and track controlled PDF copies. Predefined document taxonomy, metadata, and pick lists for quality, manufacturing, and validation documents facilitate operational harmonization and allow organizations to quickly adopt best practices. -
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Virje
Virje
Virje complies with the requirements of 21 CFR Part 11, 21 CFR Part 820, and ISO 13485. Overwhelmed by the thought of Part 11 software validation? Accessible from wherever you are, for whenever you work. Eliminate paper, reduce cost, and increase efficiency with automation and centralized collaboration. Perfect for small to medium-sized businesses. Built from the ground up specifically for medical device quality management. A system that is flexible enough to adjust to your workflows and processes, without having to compromise. Configurable change order approvals by employee role and by document type. Notifications to responsible personnel at every stage in the change process. Ability to designate material dispositions for individual documents. Easy access to released and historical versions of documents. Quick viewing of document change history. Tracking of where-used locations and distributed hard copies. Periodic document review notification. -
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Carizma QM
Axicos
Carizma QM is a web-based software that supports users in managing the entire lifecycle of regulated documents from authoring, review, approval and release to archiving. Creation and management of regulated documents, e.g. SOPs. Integrated workflows for review and approval. Automatic start of training workflow, read and understood upon approval. Electronic signature – 21 CRF part 11 compliant. Display of users who have read and understood. Validated and audit trail. Supports users to manage the entire lifecycle of regulated documents within Carizma-QM itself. The author defines key information e.g. document type (SOP, work instruction, form, checklist, etc.), title of document, process owner (department), groups of users to whom the document is applicable, review cycle. Users are defined in due time by e-mail when a document needs to be reviewed. Carizma creates the skeleton document. -
23
CaliberBRM
Caliber Technologies
In pharmaceutical manufacturing, recording shop floor activities in real-time are essential to ensure quality and compliance with 21 CFR Part 11 and GMPs. An automated system ensures that batch records are error-free and retrievable and the batch manufacturing processes are trackable. EBR software like CaliberBRM eliminates paper-based processes and risks associated with them to ensure data integrity and product quality. In life sciences and highly regulated industries, real-time entry recording of 4Ms is inevitable. It enhances the business process. You can save a lot of time and effort by digitalizing batch production records. Electronic Batch Record (EBR) System gives you complete control of the 4Ms. CaliberBRM reduces inventory wastage, checks and aligns manpower as per need, deals with instrument management, reduces review cycle time, etc. It in turn reduces operating costs. Quality Review Management (QRM) stresses performing review by exception to accelerate batch release. -
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Paradigm 3
Interax Group
Paradigm 3 is a web and desktop-based platform designed to aid businesses in compliance management in regards to Document Control, CAPA Compliance, and Competency Tracking and Training. The software offers tools such as an event manager for incident investigations and customer complaints, tasks delivered by e-mail, audit preparations, among others. Some of the industries that benefit from Paradigm 3 are Healthcare, Manufacturing, Test Labs, and Service Industries. With Paradigm 3 it is no longer necessary to buy endless add on modules to manage all your compliance needs. Our system is made up of 4 modules with over 50 standard forms to meet all of your requirements for Quality, Safety and Environmental and by utilizing our form designer you can create new forms or redesign the ones supplied to ensure they exactly meet your needs.Starting Price: $1000.00/one-time -
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SampleManager LIMS
Thermo Fisher Scientific
Drive productivity, ensure compliance, streamline processes, and improve organizational efficiency by using the world's most widely deployed LIMS (Laboratory Information Management System). Thermo Scientific™ SampleManager LIMS™ delivers laboratory management, data management, (SDMS) and process execution/procedural ELN (LES) capabilities in a single solution. Laboratories across all industries, including pharmaceutical, food and beverage, oil and gas, petrochemical, water and environmental, manufacturing and contract testing rely on SampleManager LIMS to unlock the power of their laboratory data. -
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FactoryTalk
Rockwell Automation
Industrial software designed to help you reach your manufacturing operations goals. FactoryTalk® software is built for supporting an ecosystem of advanced industrial applications, including IoT. It all starts at the edge where manufacturing happens and scales from on-premise to cloud. Imagine supercharging your industrial environment with software that offers cutting edge design, maximizes operational efficiencies, and delivers predictive and augmented maintenance advantages. From process to batch to discrete applications, your most complex challenges are solved with the combination of award-winning Rockwell Automation software, hardware, and services.Starting Price: $1000.00/one-time/user -
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Soptle
Soptle
Our goal is to make FMCG distribution equitable and more financially rewarding for the FMCG manufacturer community. A technology platform that powers manufacturers, distributors/wholesalers, and retailers with innovative products and trade services. Real-time tracking of procurement input and KPIs. Quickly access a specific sample or purchase order and analyze the procurement status directly from our interface. Track real-time production at factories and maintain a smooth material flow between departments. Generate demand from existing supply chain (distributor/wholesaler) through Soptle tech-enabled mobile application and decrease work time and increase efficiency by identifying the real machine of demand generation. Configure multiple payables and receivables in the factory to get real-time input of each and every transaction easily. Earn higher margins and a vast range of product alternatives on the Soptle app.Starting Price: Free -
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Matrix Quality
Matrix Requirements
Matrix Quality (formerly Simploud) empowers life sciences and medtech organizations to streamline compliance, enhance collaboration, and accelerate innovation while maintaining strict regulatory rigor. It replaces fragmented spreadsheets and legacy systems with a single source of truth for all quality activities. The cloud-based platform is highly flexible, scalable, and secure, designed to grow with your organization. Featuring pre-configured workflows and built-in dashboards, it provides real-time visibility into quality metrics, significantly reducing validation efforts and ensuring audit readiness at a moment's notice. -
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Browzwear
Browzwear
Browzwear is a digital product creation and development platform built for the fashion and apparel industry. It enables brands and manufacturers to design garments that fit right the first time using true-to-life virtual twins. Browzwear combines advanced 2D and 3D design tools with AI-driven fit validation and fabric simulation. Teams can iterate on fit, visualize designs, and approve products digitally before physical sampling. The platform helps reduce sampling costs and accelerate time to market. Browzwear supports real-time collaboration between design teams and manufacturing partners. It empowers data-driven decisions across the entire apparel value chain. -
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CSols AqcTools
CSols
CSols AqcTools™ v2.6 allows users to dynamically display Analytical Quality Control (AQC) charts to monitor lab performance, provides paper-free, auditable investigations of control limit failures, includes comprehensive reports and reduces the time to assess and process your QC data. Customers in water, environmental, public health sector and industrial laboratories undertaking chemical, clinical and microbiological analysis will benefit from AqcTools. It provides a selection of ‘dynamic, interactive’ charts from the standard ‘individual plotted AQC points’ to charts that can use batch or daily means of data, for both current and historic data. In addition, users can plot charts for an individual analyst to support the labs on-going analyst competency checking. All of the information relating to each individual point such as date, batch number, analyst, instrument etc. is just one mouse click away. -
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Laboneer
GramenSon Engineering Solution Pvt Ltd
Laboneer is a cloud-based Laboratory Information Management System (LIMS) built for Material Testing Labs to streamline sample tracking, workflow management, and report generation. Laboneer helps laboratories manage the complete testing lifecycle from sample inward and test allocation to result entry, approvals, and customer report delivery. Laboneer supports Construction Material Testing Labs, Food Testing Labs, Water Testing Labs, Soil Testing Labs, Oil Testing Labs, and Paint Testing Labs with centralized digital workflows, audit trails, and secure data management. Key features- sample and job management, automated report generation, QR code verification, customer management, analytics, role-based access control, accounts, inventory centand workflow automation. The platform improves operational efficiency, reduces manual paperwork, enhances traceability, helps laboratories maintain organized and compliant digital records through a secure cloud-based system as per ISO 17025 & NABLStarting Price: $100/month -
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Radley Traceability
Radley Corporation
Are you prepared for recalls or audits? Get real-time access to full bi-directional traceability! Radley Traceability is a complete track and trace software solution for the manufacturing industry. Enjoy full visibility throughout your supply chain. Powered by Radley's trademarked IntelliLabel technology, Radley’s Traceability Software lets you easily collect, store, and trace data forward and/or backward in the supply chain. Core functionalities include chain of custody, product pedigree management, configurable workflows, multiple data capture options, co-mingled lot tracking, individual part and direct part marking, serialized containers, and so much more. Supports GS1 standards for scanning & labeling. Can also be used as a stand-alone solution or integrated to your ERP/back-end system. Capture unlimited properties: lot, supplier, expiration, sample/quality, weight and transit time. -
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Match-IT
Match-IT
Match-IT is a comprehensive but affordable inquiry-to-invoice fully-integrated production control software package suitable for small to medium-sized manufacturing companies. You configure Match-IT to know about your products and resources etc and it will produce all your works orders, purchase orders etc based on your sales demand and current stock levels. Everything is completely traceable and satisfies ISO standards. A unique event diary prompts your staff to carry out their tasks; so you don’t have to. Match-IT is highly configurable, allowing you to tailor the system to your company, not your company to the system. An award-winning powerful finite element scheduler makes the most effective use of your human and machine resources while minimizing on-site stock levels. Sophisticated batch tracing allows you to quickly establish where a batch came from and where it went.Starting Price: $10000 one-time payment -
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FactoryTalk ProductionCentre
Rockwell Automation
FactoryTalk® software is built for supporting an ecosystem of advanced industrial applications, including IoT. It all starts at the edge where manufacturing happens and scales from on-premise to cloud. Imagine supercharging your industrial environment with software that offers cutting edge design, maximizes operational efficiencies, and delivers predictive and augmented maintenance advantages. From process to batch to discrete applications, your most complex challenges are solved with the combination of award-winning Rockwell Automation software, hardware, and services. Our FactoryTalk software solutions can supercharge your industrial environment. Unleash innovation with cutting edge design, maximize operational efficiencies, and harness the unlimited potential of predictive and augmented maintenance. From process to batch to discrete applications, our combination of award-winning software, hardware and service solutions solve your most complex challenges. -
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PASS
NCSS
PASS software provides sample size tools for over 1100 statistical test and confidence interval scenarios - more than double the capability of any other sample size software. Each tool has been carefully validated with published articles and/or texts. Get to know PASS by downloading a free trial, viewing the video to the right, or exploring this website. PASS has been fine-tuned for over 25 years and is now the leading sample size software choice for clinical trials, pharmaceuticals, and other medical research. It has also become a mainstay in all other fields where sample size calculation or evaluation is needed. In PASS, you can estimate the sample size for a statistical test or confidence interval in a few short steps. If you need guidance during any of the steps, PASS has excellent documentation, there are free training videos, and you can contact our team of Ph.D. statisticians.Starting Price: $395 per year -
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Augmented MES
Apprentice.io
Put power in the hands of your team. With intuitive, no-code procedure and recipe authoring designed for process scientists and process engineers, your teams can configure Tempo without code. Tempo allows users from your organization – or even across CDMO and their customers – to author recipes together in real time with live group-editing collaboration tools. Users can quickly create intelligent workflows with advanced capabilities like parallel execution, branching, and enforcement logic, as well as integrate referenceable parameters, formulas, equipment, materials, and operator actions, without a single line of code. Any user can also add augmented guidance – photos, videos, and AR overlays– to any step of a procedure. Our native mobile app and hands-free, voice-enabled headset move with you. Tempo is optimized for use in all environments – the suite, cleanrooms, and while wearing PPE. -
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1factory Manufacturing Quality
1factory
1factory's Manufacturing Quality is a cloud-based and on-premises quality control software solution specifically created for manufacturing companies of all types and sizes. Powerful, reliable, and secure Manufacturing Quality by 1factory provides first article inspections, factory monitoring, quality control plans, in-process and final inspections, incoming inspections, inspection management, CAPAs, non-conformances, and more. Additional key features include running metrics calculations for Process Performance (Pp, Ppk), Process Capability (Cp, Cpk), variation / SPC control management, defect-risk monitoring, and more. -
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PAS-X
Werum IT Solutions
With PAS-X, Werum offers a mature standard software product for the highly regulated and batch-oriented process industries. The PAS-X MES provides out-of-the-box maximum standard functionality for all applications in the pharmaceutical and biopharmaceutical sector. Companies using PAS-X benefit from lean production and operational excellence. PAS-X provides all major functionalities required for efficient pharmaceutical and biopharmaceutical manufacturing out of the box. Werum PAS-X software product meets all requirements set forth by the approving authorities, such as the FDA. The great number of PAS-X standard interfaces accelerates implementation projects and ensures seamless information exchange with all surrounding IT and production systems. The PAS-X MES supports all major pharmaceutical industry segments, e.g. for vaccines, biopharmaceuticals, solids, liquids and other manufacturing operations. -
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Manufacturing in IFS Cloud helps overcome specific challenges such as increasing production costs, inconsistent throughput, maintaining customer service levels and reducing carbon footprint. IFS Cloud uniquely combines built-in AI capabilities such as optimized scheduling and planning and intelligent automation that can increase service levels by 16%. In addition, the ability to reuse components as part of re-manufacturing and support for multi-mode manufacturing promotes the sustainability agenda and helps protect the bottom line. Manage the production process across manufacturing modes, from discrete to process, and from advanced make-to-order (MTO) to simple assemble-to-order (ATO). Plan and manufacture efficiently across your business from quotation to delivery as part of maximizing the resources available. Produce quality products with minimal wastage and low defect rates.
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QualityKick
SoftDoit
QualityKick is a QMS compliance solution in the cloud for quality management of the biological sciences. It consists of different modules; each of them solves a specific part of the quality management processes: document control, training, change control, events, CAPA, risk assessment, qualification, and audits of suppliers and equipment. As it is a web-based application, it can be accessed from anywhere and from any device mobile. Works everywhere: computer, smartphone, and tablet. Guided tour which loads automatically when new users log in for the first time. Allows you to edit documents with MS Word and send them through a configurable review and approval process. Different types of events can be configured such as deviations, nonconformities, or complaints. It is possible to define CAPA plans, record the actions, and verify their effectiveness. Solutions for quality management in the pharmacy, biotechnology, and medicine sectors. -
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InstantGMP
InstantGMP
If you’re relying on multiple software and/or paper-based solutions to manage your compliance and manufacturing process needs, InstantGMP™ could be the key that unlocks the next level of success for your business potential. Seamlessly maximize production uptime, improve batch quality and meet all FDA compliance needs—and more—all with an affordable, paperless, all-in-one software solution. InstantGMP™ products work individually and together based on your business needs to deliver comprehensive, integrated software solutions that ensure end-to-end quality, consistency and GMP compliance. We’ll help you pick the right solution set for your business needs today, and tomorrow. Organize, manage and document batches electronically while reinforcing good manufacturing practices. Inventory Management Solution that meets Part 11 and GMP requirements. Complete quality system that comes with SOPs, templates and guided workflows - ideal for virtual biotech. -
42
InSilicoTrials
InSilicoTrials
InSilicoTrials.com is a web-based platform, which provides a user-friendly computational modeling and simulation environment where many integrated easy-to-use in silico tools are readily available. The platform targets primarily users from the medical devices and pharmaceutical sectors. The in silico tools available for medical devices enable computational testing in different biomedical areas like radiology, orthopedics and cardiovascular during product design, development and validation processes. For the pharmaceutical sector, the platform provides access to in silico tools developed at all stages of the drug discovery and development processes and for many different therapeutic areas. We have built the only cloud-platform based on the crowdscience concept that makes it easy to use validated models and cut your R&D costs now. A growing catalogue of models ready to be used, on a pay per use basis. -
43
Opcenter Execution
Siemens
Orchestrate complete visibility, control, and optimization of production and processes across your enterprise with our Manufacturing Execution Systems (MES) family of products. Opcenter Execution MES products optimize manufacturing operations, accurately reflecting design, engineering, and process data in the production of actual finished products. Deliver the comprehensive digital twin to the factory floor, accelerating production by digitally linking enterprise systems with automated manufacturing equipment. Cut through the complexities of today’s products and production processes to ensure products are built as planned, on time, and cost-efficiently. Ensure that floor personnel, raw materials, supplied components, and works-in-progress are in the right place at the right time to accelerate production processes. Opcenter Execution achieves significant cycle time reductions by determining and implementing the most efficient production sequencing. -
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Nova-QMS
Novatek International
Maintaining consistent product quality and quality processes can be challenging in today’s pharmaceutical manufacturing environments. Regulated industries such as the Pharmaceutical, Biotech and Life Sciences are required to maintain Good Manufacturing Practices (GMP) to meet regulatory requirements. Not only do you need to meet GMP requirements you must also be able to prove this. Using paper-based forms, disconnected systems, or manual processes to manage, track and report on quality issues and actions does not provide effective solutions for implementing harmonized, integrated quality management processes, which follow industry best practices. -
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uniPoint Quality Management Software
uniPoint Software
uniPoint's Quality Management Software is a modular on-premise quality management software. Quality Management Software can integrate with other ERP systems with ease. Quality Management Software is suitable for manufacturers of any kind of product in any manufacturing mode. With Quality Management Software, users can manage processes such as document control, equipment management, non-conformances, corrective/prevantative actions, and more.Starting Price: $6000.00/one-time -
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Process Excellence Temple (PET)
Simplified Automation
Industry leading enterprise solution for Digital World Class Manufacturing (WCM) and Lean Manufacturing Implementation. Turbocharge your cost reduction initiatives and enhance efficiencies with effortless project management and comprehensive data analytics. Transform your maintenance program and enhance efficiencies with visualization of data and analytics at your fingertips to enable smart and faster decision making. Transform your workforce by streamlining processes and optimizing the training program to enhance employee productivity and efficiency. Transform your audit programs by streamlining and automating processes to enhance quality, safety and environmental efficiencies across the organization. -
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AmpleLogic APQR
AmpleLogic
Introducing AmpleLogic AI-based APQR software, a revolutionary solution that helps you generate accurate Product Quality Review (PQR) reports and CPV reports for audits and regulatory submissions as per the current Good Manufacturing Practices (CGMP) regulations for drug products (21 CFR 211.180(e), 21 CFR 211.180(e)). With OCR data extraction and AI chatbot integration, AmpleLogic APQR solution streamlines document data extraction and quickens access to information, boosting audit readiness and operational efficiency. -
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FactoryWorx
FactoryWorx
FactoryWorx is a technology company specializing in the design and deployment of the next-generation Manufacturing Execution System (MES) software. Designed for the manufacturing industry, with built-in IoT and AI technologies, FactoryWorxTM MES is an advanced, comprehensive, modular solution that is already driving digital factories of the future. Smart manufacturing companies of all sizes leverage our platform solutions to gain a new competitive advantage. Leverage the extraordinary adaptability and power of FactoryWorxTM MES platform solutions to drive your manufacturing operations to the next level of competitive performance and market leadership in Industry 4.0. Easily transform your operations into paperless automation with enhanced planning and control through dashboard visualization of processes, assets, inventory, and energy. Manage and lead people using our unique team collaboration feature. -
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LIMS by ABI Health
ABI Health
LIMS by ABI Health makes it easier for your lab business to grow. It takes just a few hours to open collection and processing centers. All the centers are managed under a single platform. You can expand your business, process more samples, and get real-time reports and insights. Here is an opportunity to scale-up your business in no time! Batch Processing Samples. You can process an entire batch of samples using LIMS’ unique batch sheet-tracking tool that assigns a single barcode to the entire batch. Technicians can track the sample handling in real-time as soon as it is collected and assigned a barcode using the Workflow Manager. Cut down on wasteful standby time and do away with confusion over where the sample is! Automation. Automation to save more! Time intensive and repetitive tasks can be automated, allowing for better efficiency. Integrate all equipment and devices on to a single, secure platform, thereby eliminating the manual effort of data transfer. -
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EDMS
GAEA Technologies
EDMS is used to improve and standardize environmental data collection, management, and reporting in an efficient and cost-effective manner. This is accomplished by implementing a documented, auditable process for the collection, storage, and reporting of environmental data. Throughout this process all stages of the sampling and analysis are tracked and notifications can be sent via email or SMS (text message). Notifications for non-compliance events and sample exceedences can be automatically sent by the system. The first stage in any environmental field program is the scheduling and planning of sampling events. EDMS allows project managers to design, delegate, and monitor sampling events. Sampling events can be either singular or re-occurring. Prior to data collection, sampling stations can be specified. These sample stations include information on station location and construction, sampling defaults and methodology, lab analyses required, required equipment and personnel.Starting Price: $1,695 per license