Pharmaceutical Processing created a questionnaire to learn more about MasterControl, their technologies, and some of the upcoming trends they are seeing in the industry. MasterControl will be participating in some of the technical education sessions at INTERPHEX 2016. Walt Murray, President and CEO of ARC Experts and essential part of the MasterControl QCC services team, answers our questions.
Below are the edited responses to this exclusive Q&A.
Q: Tell us a little bit about your company—what do you do and what are some of the areas that you specifically excel in?
Murray: MasterControl Inc. is a leading global provider of enterprise quality management software (EQMS) and quality consulting services for highly regulated life science businesses. We also offer solutions specifically designed for clinical quality and trial master file (TMF) management. MasterControl is really a team of quality, regulatory, and software experts who work to empower regulated companies. MasterControl encourages its customers to harness quality and compliance as business accelerators, so life-changing products are available to more people sooner.
MasterControl’s quality management software solutions reduce overall costs, increase efficiency, and accelerate compliance, all creating a significant competitive advantage for customers. MasterControl offers a suite of seamlessly integrated and scalable software solutions for quality management, document control, product lifecycle management, supplier management, audit management, training management, TMF management, clinical trial quality management, and much more.
I work with the MasterControl product development group to formulate the technology for quality processes software. I also contract with companies who need to develop quality systems: design control, issue resolution, audits, and manufacturing processes and management involvement.
Q: What don’t most people realize about your company?
Murray: MasterControl is almost 25 years old and is the first company to deliver a cloud-based EQMS for life sciences and regulated manufacturers. MasterControl is also one of the first companies in the world to successfully complete a full certification audit to the newly revised ISO 9001:2015 standard. Many people aren’t aware that MasterControl also offers some of the only (and in my albeit biased opinion, best) clinical quality management systems (CQMS) and TMF management solutions available on the market today. As a company, MasterControl has enjoyed almost double digit growth for the last seven years, thanks to unparalleled products and the fact that many of the MasterControl team members come from the industries they serve, so they understand their pain points.
Q: What is one of the biggest successes of your company?
Murray: In regards to MasterControl’s Quality Consulting Services, one of the greatest recent successes has been helping a newly formed medical device company get their product to market in under eight months while executing a successful 510k submission process and building a robust quality system. And we have now become a virtual quality unit for that business! We have also taken several companies who have received remediation warning letters from the FDA and turned them into successful operations by refining their quality systems.
Q: Are there other areas in the pharmaceutical industry that your company is hoping to delve into? If so, please explain.
Murray: There are two that come to mind (areas where MasterControl’s products could be harnessed). The first is 503 A&B—the trend of traditional pharmacies going into production orientation. This could be big for us from a business prospective. The second is Design and Chemical Manufacturing and Compliance, (CMC) support for operations in pharmaceuticals.
Q: What are some of the biggest challenges in your industry?
Murray: The number one challenge is the lack of awareness C-level and mid-management has about quality management systems. Standards and federal regulations stipulate that the top management must be involved with quality systems and must understand what’s at stake. C-level company personnel have the specific responsibility for making sure that there are always enough resources for quality systems, and the system must be robust enough to do what it is designed to do.
Q: What is one of the biggest areas of growth your industry has seen in recent years?
Murray: An area of growth we have seen recently is the support for quality management in start-up companies, specifically in the in vitro diagnostics (IVD) laboratory developed tests (LDTs), nanobiotechnology, and incubator-launch companies with very sophisticated product commercialization.
Q: Where do you see the industry going in the next 10 years? Your area of expertise?
Murray: For the quality management industry in pharma, software is going to be huge on the horizon, software that is configurable and scalable. And companies will start looking to their quality management systems for data that can be used in their company’s overall business intelligence. And I believe consulting resources will be much more technically qualified, due to the software and data in use by the industry.
Q: What would you consider to be a major achievement for the industry in the near future?
Murray: I believe a major achievement for quality management in pharma would be the ability of more companies to apply innovation in operations using critical thinking skills (CTS).
Q: I see you will be participating in a presentation, titled “Establishing Design Parameters to Validate Final Product Specifications Using a Risk-Based Phased Design Control Approach,” on Wednesday, April 27. Could you tell us a little bit about what you’re going to be discussing and what people will learn from attending?
Murray: I will be discussing the importance of risk-based thinking and the role it plays in using Quality by Design (QbD) tools. I will also be covering the new process validation orientation: Process Design/Process Product Qualification/Product & Process Control (PD/PPQ/P&PC). This new approach is risk-based and much more oriented toward process improvement. Attendees will also be exposed to critical thinking skills (CTS) as part of process improvement.
Q: What are you most looking forward to at INTERPHEX this year?
Murray: I am looking forward to the interaction with colleagues for both professional networking and gaining exposure to technical information.
Q: What is one of your favorite INTERPHEX memories?
Murray: There are a few, but one that stands out is actually being on the show floor and seeing the variety of innovation. Another favorite memory of mine is being able to view the Westside skyline at night and getting to ride the water taxis to the expo every day.
Q: If your company was a superhero, what superhero would it be?
Murray: By definition, we make a lot of big changes in little ways, so Ant-Man would probably be the best suited superhero.
Pharmaceutical Processing is a platinum sponsor of INTERPHEX.
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