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Advancing Quality Culture in Biomanufacturing: Best Practices
BioPhorum and MasterControl Collaboration on Quality Culture
As a proud contributor to BioPhorum's recent publication "Best practice guide to implementing and maintaining a world-class quality culture,[1]" MasterControl has been at the forefront of advancing quality management practices across the biomanufacturing industry. I was honored to be invited to contribute to this comprehensive guide, which was developed with input from industry leaders and offers practical frameworks for establishing robust quality cultures that go beyond mere compliance to drive performance and innovation.
Defining Quality Culture: Insights from the BioPhorum Report
The BioPhorum report defines quality culture as "an environment where every employee can hear, see and feel quality around them." It's about creating an environment where people "do the right thing when no one is watching, and where management and employees tell each other what they need to know, not what they want to hear."
Through our collaborative work with BioPhorum, three essential pillars of quality culture have been identified:
- Leadership Commitment: As noted in the report, leaders must "exemplify the expected quality behaviors" by listening actively, ensuring psychological safety, avoiding blame, providing guidance, taking actions, coaching, and thinking "patient first."
- Employee Ownership: The BioPhorum guide emphasizes that "at a site level, it is not only the quality department that is responsible for quality; ownership is with every employee."
- Continuous Improvement: The report highlights that in mature organizations, "everyone proactively identifies quality improvement opportunities rather than firefighting."
As I stated in the BioPhorum publication: "We think of culture as the way that work gets done in our organization... a good bar for whether or not we've truly achieved a quality culture is asking ourselves if quality is inherently embedded in the way that our work gets done. Your company culture and quality culture should be one and the same."
Implementing Quality Culture: Proven Approaches From the BioPhorum Collaborative
The BioPhorum report to which MasterControl contributed identifies several effective approaches to implementing quality culture:
- E-learning: The report notes how companies are using "e-learning and leverage new technologies, such as avatars, to introduce a company's approach to quality" – an approach MasterControl has helped pioneer with our training management solutions.
- Workshops: BioPhorum members found that quality culture workshops help "employees learn about quality culture and the role that everyone plays in shaping this culture for the organization."
- Quality Days: The report highlights how "quality promotion events, such as annual quality days", can stress the importance of quality and demonstrate leadership commitment.
According to BioPhorum's benchmarking survey, the most effective techniques for implementing quality culture programs include designated "champions" across various levels of the organization and placing senior stakeholders who can extract the value of quality culture.
Technology's Role: Aligning MasterControl Solutions With BioPhorum Findings
The BioPhorum report extensively discusses "Technology's role in attracting the next generation of quality culture professionals." This section aligns perfectly with MasterControl's vision for digital transformation in life sciences manufacturing and the increasing adoption of purpose-built biopharma manufacturing software.
The report highlights that "advances in technology, especially in the use of generative AI, pose some important questions for the quality profession," including how these technologies can help advance quality culture. MasterControl's AI-enabled platform addresses these questions by connecting purpose-built tools with quality management modules while maintaining security and validation requirements.
BioPhorum's report notes that "Gen Z and younger generations are coming into our organizations with higher and different expectations than older generations." MasterControl's digital solutions are designed with these expectations in mind, providing modern interfaces and AI-assisted workflows that appeal to digital natives.
To explore the potential of AI in quality management further, download our "How to Implement AI in Life Sciences Quality: 5 Strategic Areas" checklist.
Implementing Quality Culture Best Practices
MasterControl's quality management system (QMS) and manufacturing execution system (MES) solutions directly support the quality culture measurement approaches described in the BioPhorum report. For example, the report describes how "dashboards can be very powerful and are used to show high-level trends and progress, and allow drilling down into the details to highlight specific areas" – capabilities that are core to MasterControl's analytics offerings.
Organizations using modern biopharma manufacturing software solutions like MasterControl have implemented many of the report's recommended approaches, including:
- Digital quality management systems and practices that support the "continuous measuring" element described in the BioPhorum report.
- Tools for improved leadership visibility aligned with the "leadership and role modeling" elements.
- Platforms for communication and knowledge sharing that enable the "ambassador network" described in the report.
Future Collaboration: MasterControl and BioPhorum
As BioPhorum continues its important work in advancing quality culture across the biopharmaceutical industry, MasterControl remains committed to developing technologies that support these efforts. The report concludes that organizations should consider "leveraging digital tools and AI to enhance quality systems and support decision-making" – precisely the direction MasterControl is heading.
Our ongoing collaboration with BioPhorum and its member companies ensures that our solutions continue to evolve in alignment with industry best practices for quality culture. Together, we're working to build a future where technology enables rather than impedes quality culture, helping organizations across the biomanufacturing sector deliver life-changing therapies to patients more efficiently and reliably.
For more insights on implementing quality culture best practices through technology, download our "How to Implement AI in Life Sciences Quality: 5 Strategic Areas" checklist, which builds upon the principles outlined in the BioPhorum quality culture guide.
References:
- "Best practice guide to implementing and maintaining a world-class quality culture," BioPhorum, Oct. 8, 2025.
Matt Lowe has served MasterControl for nearly two decades across several different executive leadership roles including product, engineering, sales, and marketing, and now will continue his tenure as Chief Strategy Officer. In this role, Lowe brings vast institutional knowledge of the market, MasterControl’s products, and customers to identify growth strategies and expansion opportunities for the company. He also serves on the MasterControl Board of Directors.
Lowe is a medical device expert with experience in product development and product management at Ortho Development Corp. and Bard Access Systems, a subsidiary of BD. Lowe has successfully launched more than a dozen medical devices. He has five patents issued and one pending. His regulatory experience includes writing a 510(k) that was cleared by the FDA and managing a multi-site, multi-year post-market clinical study for orthopaedic devices.
Lowe has a bachelor's degree in mechanical engineering from the University of Utah and an MBA from Indiana University.
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