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.


  • Read how a smarter, faster and smaller approach to eliminating paper processes could provide the evidence people seek to pursue a digital transformation.

  • MasterControl is the foundation for connected quality data and complete product quality. It unifies applications, data, and documentation across your entire product development life cycle, from concept to commercialization. Go beyond proactive quality management and unleash the intelligence and insights concealed in unstructured data. Discover how the MasterControl Platform can make your vision of truly connected quality data a reality.

  • How adopting a data-driven and technology-supported approach to quality and product life cycle management can enable pharma and biotech organizations to not just survive, but thrive.

  • This guide will help you understand the fundamental components of a Quality Management System (QMS) software and how QMS solutions are evolving to keep pace with business dynamics.

  • This ebook explores the current landscape of the medical device industry and the forces taking shape today that will drive growth into 2030 and beyond. From new technology to shifting patients’ experiences, we’ll explore how a wide range of issues are affecting product development and innovation, as well as the impact of digitization and data when it comes to device regulations and operations.

  • The digital documentation layer of quality and compliance processes is still critical and will never go away, but advanced technologies are helping life sciences organizations unlock the data side of the equation.


Using Document Change Control Software in Regulated Environments

Change is important in any business, but it is especially critical in life science, manufacturing, and other regulated companies, which are required to "control" change as part of compliance. This is why many companies are turning to document change control software to help them address the complexity of change control.

In regulated environments, the term "document change control" may refer to the document management or document control process, or it may to refer to the change control process, which involves rigorous documentation. Either way, most companies need document change control software to manage these processes.

CGMP software helps automate and standardize processes to get to market faster. GMP quality systems connect and ensure quality throughout the product life cycle. Information is maintained in a central location. Compliance is simple.

Why Implement an FDA 21 CFR Part 11 Pharmaceutical Software System?

Learn from industry practitioners and experts why implementing an FDA 21 CFR Part 11 Software System is so essential. Within a year of 21 CFR Part 11 first going into effect MasterControl introduced the industry's first document management software solution specifically designed to help life sciences organizations comply with FDA regulations, the regulations delineated in 21 CFR Part 11 in particular. MasterControl's solutions streamline and automate GxP processes and facilitate effective management of document control, change control, training control, audits, corrective/preventative action (CAPA), customer complaints, and other quality and business processes, all under a single Web-based platform.

Managing documents, training, and business processes are nightmares shared by all pharmaceutical and biotech companies and MasterControl provides pharmaceutical quality management software systems to take them out from that nightmare. MasterControl's QMS software exchanges the nightmares for a dream of a solution that enables pharma companies get their products to market faster and improve compliance at the same time. MasterControl pharma QMS software has been specifically designed to help manage all documents and automate regulatory-related processes and training in a single platform.

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.

MasterControl delivers the next level of manufacturing excellence by bridging the gap between performance and quality with digital production records that finally let you go 100% paperless.

MasterControl’s eCTD submission and product registration management software automates, simplifies and accelerates submissions and product registrations.

Ensure compliance and improve efficiency by automating your paper-based systems.

The out-of-specification (OOS) product in the MasterControl Quality Management System (QMS) allows for seamless compliance.

Managing an electronic trial master file (eTMF) is a complex and labor-intensive effort. Centralize and streamline your clinical activities with MasterControl eTMF software systems.

MasterControl's supplier management solution automates supplier management processes and ensures supplier quality and compliance.

A clear path to global regulatory submissions.

Simplify clinical management with a single platform. MasterControl allows you to connect all clinical data, documents, tasks and processes.

Automate batch processes. Improve efficiency. Ease growing pains. A proven recipe management software system can help you do it all.

MasterControl software automates equipment calibration processes. It helps manufacturers improve their performance and ensure audit-readiness.

MasterControl’s audit management software system automates tasks so that companies can successfully pass audits.

Unify all risk-related activities and documents for efficient and consistent risk management.

Streamlined investigation and resolution of product deviations. Improved quality. Simplified compliance. MasterControl deviation management software can help you make it happen.

Quality events are inevitable, no matter how much care is taken to avoid them. As a critical part of a quality management system, CAPA identifies and addresses the root causes of high-risk quality issues and helps to limit the resulting business impact, both immediately and in the future.

Make sure gaps in employee training don’t derail your regulatory compliance.


MasterControl, Inc.

6350 South 3000 East

Salt Lake City, UT 84121


Phone: Sales 1.888.873.5164