The MASTERS of EXCELLENCE

2024 Quality Champion Award

Brittany Byington, Thermo Fisher Scientific

Longtime MasterControl user Brittany Byington was celebrated for her instrumental role as a system administrator at Thermo Fisher Scientific, where she has been a driving force behind the adoption of MasterControl software solutions. Renowned for her infectious "can-do" attitude and problem-solving skills, Byington tackles and resolves challenges with unmatched determination and expertise. Her significant contributions to her company’s Quality, Regulatory, and Validation Technologies team have made her an indispensable leader within the organization.

2024 Digital Transformation in Manufacturing Award

Repligen

Michael Murphy, Associate Director, Automation & OT, accepted the Digital Transformation in Manufacturing award for Repligen, where he has been pivotal in championing the use of MasterControl’s Manufacturing Excellence (Mx) module. Through rigorous analysis, Murphy demonstrated to his organization that incorporating Mx improved production output by 31% year over year. Despite facing initial skepticism, Murphy’s pursuit of concrete data showcased the significant benefits of Mx, leading to substantial efficiency gains and proving the value Mx could bring to other Repligen sites. The implementation of Mx has helped Repligen decrease manufacturing review time per batch by 43% and QA review time per batch by 75%. Additionally, Mx has helped Repligen decrease execution hours by 50%, coinciding with a 31% year-over-year increase in production output.

2024 Excellence in Analytics Award

Linde Gas & Equipment

Associate Director of Quality Zachary Fowler accepted the Excellence in Analytics award for Linde Gas & Equipment as the organization was honored for its innovative use of MasterControl Insights to track manufacturing process execution times. Fowler and his team have created custom dashboards that enhance production record execution efficiency, saving critical hours and ensuring timely batch record execution. Their detailed attention to data analytics exemplifies how the strategic use of MasterControl Insights can drive substantial product improvements.

2024 Innovation Excellence Award

A2 Biotherapeutics

QA Specialist Dan Lombardo accepted the Innovation Excellence award on behalf of A2 Bio, a biotech company that was recognized for its groundbreaking work in developing logic-gated cell therapies to meet unmet needs in cancer treatment. The company’s proprietary Tmod™ cell therapy platform distinguishes between tumor and normal cells, representing a significant advancement in cancer therapy.

2024 Quality Champion

Rose Koenings of Sterling Pharma Solutions

Rose has configured MasterControl for four 4 Sterling sites, including two of largest sites in the UK and Ireland. As the global MasterControl QMS system administrator and manager at Sterling, Rose oversees sub admins across Sterling’s network of sites. She has played a pivotal role in migrating data and upgrading MasterControl. Additionally, she develops strategic plans for implementations and standardizes processes through configuration rules and training videos. She is committed to promoting standardization and continuous improvement across Sterling's global operations.

2024 Excellence in Analytics

British American Tobacco

As an early adopter of MasterControl Insights they’ve improved their data analytics and played a key role in the product’s continuous improvement. They’ve leveraged customized reports to keep teams on track and to identify trends to help boost efficiency and effectiveness. In all, the team estimates they’ve reduced the amount of time they spend collecting, formatting, readying data for analysis by at least four hours per week.

2024 Innovation Excellence

Compass Pathways

The team at Compass Pathways is developing proven innovations that address the mental health issues that touch every family around the globe. They’ve opened the Centre for Mental Health Research and Innovations in partnership with South London and Maudsley NHS Foundation Trust and King’s College London. They’ve also recently launched a phase 3 clinical study of innovative ways to use psilocybin to combat treatment-resistant depression.

2024 Digital Transformation in Manufacturing

bioMérieux

As they struggled with the difficulties of data access, usability, and data integrity that come with paper-based batch records, the team at bioMérieux knew they needed to change, fast. Within one year they implemented Manufacturing Excellences on more than 20 manufacturing lines across 5 sites. They’ve seen immediate results with fewer errors, faster review times, and the automatic data collection directly from equipment on their manufacturing lines.

2023 Quality Champion

Kate Selzman of Alcami

Kate has supported an exceptional culture of quality at Alcami in 59 departments across 10 sites. To date, they’ve had 1,855 client audits and 48 regulatory inspections, with no critical audit and inspection findings related to the compliance, validation, and use of MasterControl.

2023 Excellence in Analytics

Pine Pharmaceuticals

Using MasterControl Insights, Pine continuously compiles data on defects impacting product rejection during the visual inspection phase. They can now anticipate operator defect trends before they occur and use the data to proactively coach operators on what needs to be fixed before the issue escalates.

2023 Innovation Excellence

Oncocyte

Oncocyte is committed to transforming the standard of care by advancing personalized medicine through molecular testing to ensure the right treatment for the right patient at the right time. Oncocyte’s molecular tests span over the Transplant and Oncology communities with the goal of preventing expensive, unnecessary, and sometimes harmful treatment when patients are unlikely to benefit.

2023 Digital Transformation in Manufacturing

QuVa

QuVa's manufacturing operations have gone fully digital at their Sugarland facility with an average of 450 operators using digital production records. They've completed 43,000 batch records and have over 1 million data captures using Manufacturing Excellence.

2023 Quality Champion

Wilma de Koning at Elekta

Wilma heads quality assurance and IT teams that have made big moves to drive better quality at Elekta. After moving from on-premise to Cloud, she’s now leading the charge to help her team become early adopters in the advanced QEM product.

2023 Excellence in Analytics

Klosterfrau Group

A leader in nature-based healthcare products. They have implemented MasterControl at 9 sites in 6 countries. By opening MasterControl Premium Insights to every department, they allowed the QA and IT teams to focus on quality initiatives instead of creating reports.

2023 Innovation Excellence

OrganOx

The OrganOx metra enables functional assessment of donor livers pre-transplant, resulting in 50% fewer liver discards and 20% more transplanted livers when compared with static cold storage. To date, the OrganOx metra has supported more than 2,000 liver transplants around the world.

2023 Digital Transformation in Manufacturing

Exstent

Exstent Limited configured digital production records in just six months. Just 30 days later, all employee training records were up to date and digital production records were fully employed. The whole production team are proficient in the completion of electronic production records and use iPads in the clean room.

2022 Innovation Excellence Award

Noveome Biotherapeutics

With ST266 the team has developed a first-of-its-kind, multi-targeted, non-cellular novel biologic with the potential to improve patients’ outcomes across a range of challenging diseases and conditions.

2022 Quality Champion Award

Eli Tuber at Carestream Health

Eli transformed a disconnected legacy quality system into a powerfully efficient digital solution. His 4000 users have churned out over 375,000 production records – more than any other MasterControl customer.

2022 Digital Transformation in Manufacturing Award

Northeast Scientific

As the market leader in high-end medical device reprocessing, their team digitized three product families across eight production lines. This enabled them to deliver a 500% increase in 510(k) submissions.

2022 Excellence in Analytics Award

Thermo Fisher Scientific

A true leader in life sciences, they’ve baked data and analytics into their quality and regulatory strategy. The team developed toolkits that empower more than 30,000 users to use data to work faster and smarter.