MasterControl B2B Case Studies & Customer Successes

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MasterControl Inc. is a leading provider of cloud-based Quality Management System (QMS) and Manufacturing Execution System (MES) for life sciences and other regulated industries. Our mission is the same as that of our customers – to bring life-changing products to more people sooner. The MasterControl Platform helps organizations digitize, automate and connect critical processes across the regulated product development life cycle. Unlocking the Next Decade of Medical Device Growth The medical device industry is constantly evolving. An aging world population, emerging markets, increased regulation, digitization and other trends are radically transforming the industry. Device companies that are poised to take advantage of these developments will become market leaders, while companies limited by antiquated operational or technology processes will find it difficult to adapt. The MasterControl product lifecycle excellence platform is designed to provide medical device companies a single source of truth for product quality data across the entire enterprise and the wider ecosystem. It helps ensure that all teams working in regulatory, quality, supplier, manufacturing and postmarket functions can access the information they need to do their jobs more efficiently and effectively. Quality Management System MasterControl is the #1 QMS for Life Science. Suited for startups to enterprise businesses (50 – 10,000+). A cloud-based quality and compliance software built for the life sciences and other regulated industries, our mission is to bring life-changing products to more people sooner. The complete platform helps organizations digitize, automate and connect quality and compliance processes across the regulated product development life cycle. MasterControl has been delivering quality excellence for over 25 years. We continue to improve our quality management solution to meet the needs of highly regulated industries - like life sciences - as they embrace new levels of digitization and automation and require quality management practices that are more dynamic, connected and scalable. Manufacturing Execution Systems (MES) A traditional MES is too complex. Our solution is disrupting the market with a modern, cloud-based alternative that is fast to deploy, simple to configure, easy to use, and cost-effective to roll out across all your lines and sites. A Modern MES for Modern Manufacturers Most CMOs deal with multiple clients or sponsors so there manufacturing, lab and quality systems must be designed to give them maximum flexibility. However, sponsors are ultimately responsible for product quality and cGMP compliance, so it’s crucial for CMOs to have solutions they can trust. Our modern Manufacturing Execution System (MES) is disrupting the market with a modern, cloud-based alternative that is fast to deploy, simple to configure, easy to use, and cost-effective to roll out across all your lines and sites. It delivers the agility and scalability needed to support change and growth for companies of all sizes. With flexible pricing plans, the MasterControl solution is far more cost-effective than a traditional MES. That means you gain more while spending less. Modern Manufacturing Execution System MasterControl’s modern Manufacturing Execution System (MES) is disrupting the market with a modern, cloud-based alternative that is fast to deploy, simple to configure, easy to use, and cost-effective to roll out across all your lines and sites. MasterControl’s Manufacturing Execution System delivers the agility and scalability needed to support change and growth for companies of all sizes. With flexible pricing plans, the MasterControl manufacturing software solution is far more cost-effective than a traditional MES. That means you gain more while spending less. A Modern MES for Modern Manufacturers With less dependence on blockbuster drugs and devices produced at a high volume, manufacturers are prioritizing faster, more flexible manufacturing models. Contract Manufacturing Organizations (CMOs) must excel at efficiently managing multiple clients and products while simultaneously delivering high product quality on tight timelines and within even tighter margins. Most CMOs deal with multiple clients or sponsors so their manufacturing, lab and quality systems must be designed to give them maximum flexibility. However, sponsors are ultimately responsible for product quality and cGMP compliance, so it’s crucial for CMOs to have solutions they can trust. Differentiate by providing greater visibility and accountability into quality and compliance processes to your clients. MasterControl’s modern manufacturing execution system: - Ensures GMP compliant production records (EBR/eDHR) and eliminates common GMP errors. - Ensures operators always have current work instructions and SOPs and automates training enforcement. - Enables digital review by exception, including WIP views of deviations, corrections, or form launches. - Unlocks production data to drive better decision-making through advanced analytics. - Integrates with business critical manufacturing software and systems. Multiple Clients – Many Products Manufacturing Excellence accelerates production set up with an innovative builder tool for rapidly building out your process and creating master batch record templates. Flexible Production – Fast Changeovers Manufacturing Excellence is a highly configurable cloud solution, that enables contract manufacturers to deploy/change/validate production records, SOPs, work instructions and quality processes quickly. Scalable Capacity – Superior Quality Manufacturing Excellence eliminates over 90% of data input errors for right-first-time production; enables review by exception which accelerates product release and increases capacity/cash flow. MasterControl Manufacturing Excellence Clients Have: - Reported digital master record creation in under an 1 hour - Increased operational efficiency by 30% - Automated operator training enforcement - Ensured current SOPs and work instructions - Cut data entry errors by more than 90% - Shortened GMP review by more than 75% - Improved overall quality and right-first-time

Case Studies

Showing 55 MasterControl Customer Success Stories

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Actelion achieves compliance and efficiency with MasterControl (Quatro)

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Almac Sciences Accelerates Contract Manufacturing With Electronic Batch Records

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Amplitude achieves streamlined, compliant quality management with MasterControl eQMS

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Aplicare achieves efficient, FDA-compliant electronic document management with MasterControl

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ARUP Laboratories achieves automated document control and faster turnaround with MasterControl

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Ash Stevens achieves streamlined equipment calibration and maintenance compliance with MasterControl

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Asymtek achieves 50% faster approvals and streamlined web-based document control with MasterControl

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Bio-Imaging Technologies achieves streamlined GxP compliance and automated training management with MasterControl

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How To Get Products to Patients Faster With a Connected Quality Management System and Electronic Batch Records

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BraveHeart Wireless achieves 510(k) approval in seven months with MasterControl

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Carestream achieves streamlined digital manufacturing and improved quality with MasterControl

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Cell Culture Company (C3) achieves streamlined training and audit-ready documentation with MasterControl Spark

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Dendreon achieves right‑first‑time, paperless PROVENGE production with MasterControl Manufacturing Excellence (Mx)

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Ecolab achieves streamlined, multilingual document and training control with MasterControl

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EMD Chemicals achieves centralized document control and streamlined processes with MasterControl

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Fagron (pharmaceutical compounding company) achieves global quality consistency and paperless training with MasterControl

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Gendex achieves company-wide document control and task visibility with MasterControl

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Gift of Life Michigan achieves rapid user adoption and an FDA‑compliant quality system with MasterControl

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Heraeus Materials Technology achieves ISO 9001 compliance and company-wide workflow control with MasterControl

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Hu-Friedy, global leader in dental instruments, achieves FDA and ISO compliance and cuts document cycle time with MasterControl

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ITxM achieves 10 years of centralized, compliant quality management and improved efficiency with MasterControl

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LifeCenter Northwest achieves successful system validation and go‑live with MasterControl

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MacroGenics achieves faster validation and cloud-based compliance with MasterControl

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Mallinckrodt Pharmaceuticals achieves globalized, integrated quality management with MasterControl's web-based QMS

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MD Anderson Cancer Center achieves streamlined software implementation with MasterControl on-site training

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Medisca achieves audit-ready flexibility and faster audits with MasterControl

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Megadyne Medical Products achieves multi-agency regulatory compliance and faster change control with MasterControl

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Merz Aesthetics achieves 33% faster document changes and streamlined training with MasterControl

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MicroMed Cardiovascular achieves accelerated compliance and increased efficiency with MasterControl

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NAMSA (North American Science Associates) achieves rigorous FDA and ISO compliance with MasterControl

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Digital Quality Management Enables Innovation at Navigate BioPharma Services, Inc.

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Nelson Laboratories achieves streamlined, secure logins and eliminates password headaches with MasterControl

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Northeast Scientific achieves faster regulatory approvals and scalable, compliant manufacturing with MasterControl

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Oil States Industries achieves ISO certification, streamlined global document control, and cost savings with MasterControl

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OPK Biotech achieves successful implementation and faster SOP access with MasterControl

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Paragon Biomedical achieves a streamlined, compliant QMS with MasterControl

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Digital Transformation Fuels Growth at Pine Pharmaceuticals

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QuVa Pharma achieves streamlined, paperless lab operations and improved quality with MasterControl Manufacturing Excellence

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Schiff Nutrition International achieves FDA Part 111/Part 11 compliance and streamlined batch-record ERP integration with MasterControl

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Schiff Nutrition International achieves rapid FDA compliance and integrated batch-record automation with MasterControl

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Schiff Nutrition International achieves faster discontinued-product management with MasterControl

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Sorenson Medical strengthens compliance and streamlines quality management with MasterControl

StayinFront achieves FDA-level quality system compliance with MasterControl

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SynCardia Systems achieves audit-ready compliance and streamlined document management with MasterControl

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Teva Pharmaceutical Industries achieves accurate, efficient FDA compliance with MasterControl

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The Blood Center of Iowa achieves improved quality and efficiency with MasterControl

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The Tech Group achieves automated, compliant preventive maintenance with MasterControl

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UCSF Medical Center achieves improved quality across 53 departments with MasterControl

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Unity Lab Services achieves assurance of current content and streamlined document management with MasterControl

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Vascutek (a Terumo Company) achieves compliance and cost savings with MasterControl

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WD-40 achieves consistent global product quality and right-first-time results with MasterControl

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Weaver and Company achieves paperless production and halved batch release times with MasterControl

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Weider Nutrition International achieves faster approvals and stronger regulatory compliance with MasterControl

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Wellington Foods achieves scalability, 90–100% fewer data errors and 72‑hour post‑production reviews with MasterControl

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Zarbee's Naturals achieves streamlined, cloud-based document control and improved regulatory compliance with MasterControl Spark

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