MasterControl Resource Centre

Find out how Pine Pharmaceuticals went from being one of the first compounding facilities in the U.S. to be registered as a 503B facility to a leading supplier of compound pharmaceuticals for specialty practices and hospitals. Learn the important role their quality management system (QMS) plays in their day-to-day business. Read about the manufacturing advantages they’ve gained by having their electronic batch records (EBR) and QMS on the same platform. You’ll even get a glimpse at the incredible efficiency and time-saving benefits they’ve seen by switching to electronic logbook software. Best of all, they didn’t need to invest in a variety of different solutions to realize all these benefits. They simply went with MasterControl.

Navigate BioPharma uses MasterControl’s quality management system (QMS) to encourage innovation and automate compliance.

Almac Sciences is known for being able to handle difficult specifications, but their production was limited by their extensive paper-based processes. This case study from MasterControl explores the challenges the company faced and how the Manufacturing Excellence solution helped them to quickly compete in the emergent personalized medicines marketplace – all while maintaining quality standards and compliance.

The case study featuring BioBridge Global details how the non-profit 501(c)(3) organization with four subsidiary companies transitioned from a paper-based to digital operation. The case study includes comments from various personnel from the different companies explaining how using Quality Excellence and later Manufacturing Excellence reduces errors and delays and gets products to patients faster.

A case study of how Dendreon, a pioneer in cellular therapeutics, has embedded quality into manufacturing with MasterControl’s modern manufacturing solution, Manufacturing Excellence. Learn how their digital transformation, complete with electronic batch records, connected real-time data and reporting, and in-process compliance management has decreased batch release time, increased efficiency, and connected siloed teams.

Northeast Scientific is the market leader in high-end peripheral vascular catheter remanufacturing with an ever-expanding portfolio of devices in both development and for commercial sale. The company needed a way to scale its operation to meet the growing demand for its products, introduce new products, and remain compliant with the evolving regulatory requirements. In this case study, Northeast Scientific staff tell how the company achieved these goals and more by implementing MasterControl’s Quality Excellence and Manufacturing Excellence solutions.

As Weaver and Company has grown and relevant regulations have evolved, the manufacturer recognized that managing paper quality and production documents was no longer practical. With MasterControl's electronic quality management system and electronic production record solution, Weaver and Company has improved collaboration, data collection and visibility; has streamlined the batch review and release process; and is better positioned to ensure regulatory compliance.

QuVa Pharma is a 503B compounding facility that has a large catalog of medicines it produces for health care organizations to use across a broad spectrum of patients. To help drive growth and take on a larger role as a solution provider in the health care value chain, QuVa Pharma needed a way to improve testing efficiency — including reducing errors, aligning lab operations and quality efforts, making better use of resources and eliminating paper-based processes. In this case study, Jennifer Rodriguez, Corporate Quality Systems Manager, tells about how using MasterControl Manufacturing Excellence (Mx) has significantly improved process throughput, employee proficiency, cross-functional team collaboration and quality.

Despite the digital innovation in its medical device product, Carestream's own technology stack hasn't heavily leveraged modern digital applications and tools. Eli Tuber, process manager at Carestream, is leading a digital transformation of the company's operational technology in much the same way as the company's product transformation - from outdated legacy systems to modern digital platforms. This case study highlights how a platform approach to technology modernization, including electronic device history records (eDHR), is transforming Carestream's manufacturing performance and quality.

Wellington Foods selected MasterControl to help them scale, eliminate errors and improve compliance. With the switch to a paperless production system and implementation of electronic batch records (EBR), they saw significant results including a decrease in data input errors by 90%-100% and reduction in time to complete post-production review by 75%-80%.