By Paul Thomas, Senior Editor

Dyadem (Toronto) is a provider of Quality Risk Management (QRM) solutions for various industries. For biotech and pharma, it pledges to significantly streamline risk management efforts and provide a foundation for an ICH Q10 Pharmaceutical Quality System.

It’s Stature platform and solutions aid in web-based collaboration at the workgroup, facility, and global level. Stature, according to company literature, “ensures continuous improvement through cross-functional collaboration, a closed-loop quality lifecycle and enterprise quality standardization that leverages the deep knowledge-base in your organization. Most importantly, Stature enables early planning and specification of quality where it has the most impact—before design.”

CEO Kevin North, a finalist for Ernst & Young’s 2009 Entrepreneur of the Year, shares his vision for the pharma industry with us:

PQbD: Many of Dyadem’s solutions fall in line with FDA’s Quality by Design initiative, especially in regards to risk mitigation and lifecycle management. How much of this is planned and how much is coincidence? Is the industry gravitating towards products such as yours?

K.N.: Our Stature enterprise risk management platform aligns perfectly with FDA’s Quality by Design initiative, helping FDA-regulated companies more easily manage risk and the lifecycle of their products. We did not develop Stature purely for FDA compliance, but we did make it flexible and configurable to any risk management methodology. The FDA created Quality by Design based on its Good Manufacturing Practices of the 21st Century, which are found across every manufacturing industry.

Our software platform is based on the core tenet of risk management, which is continuous improvement. Our software allows this cyclical process, continuously identifying, measuring, mitigating and communicating risks to all stakeholders. The industry is most definitely gravitating to Stature and software like it. We’ve heard from several of our customers going through PMA that the FDA uses our reporting templates as an industry benchmark, because of the ease of use for the user and for the FDA. Once information is input into our Stature platform, FDA reports can be generated and information can be manipulated without added formatting. 

PQbD: Where is Quality by Design in pharma right now, and what kinds of struggles do you see manufacturers having in implementing it?

K.N.: Most FDA-regulated companies will tell you that they believe in the FDA’s QbD initiative, but they have a hard time putting it into practice efficiently, especially since many haven’t updated their risk management procedures since the advent of spreadsheet software. Many companies use Excel spreadsheets or customized software for each department and then spend hours trying to cut and paste information together to represent quality for the whole company. Companies that take Quality Risk Management seriously need software that was designed for risk management, not accounting.

PQbD: What’s the role of IT in QbD? Is IT a just a “tool” to enable QbD, or is it more than that?

K.N.: QbD is and will always be a strategy for companies. IT can help enact this strategy and make it more efficient, but companies must first commit to the Quality by Design concept before looking for IT to solve their problems. IT like our Stature solution can ease the strain that comes with any major management initiative like Quality by Design. While most companies would like to think that they have sound quality practices, moving to an enterprise platform like Stature will reveal many new surprises, sometimes in the form of buried information that every company executive can appreciate.

PQbD: Beyond investing in software and solutions such as yours, what can companies be doing to create a QbD mindset within their manufacturing organizations?

K.N.: Quality is certainly a company culture. We find that the companies most successful at Quality Risk Management are the ones in which each employee feels empowered to be a part of the quality process. And the quality process needs to start at R&D and go through to post-production. Embedding quality into corporate culture also requires the breakdown of the proverbial walls that often exist between departments. Information needs to be shared not only vertically but also laterally so that everyone is working from the same information and always improving quality.

PQbD: Many of your solutions are predicated upon manufacturers’ capturing knowledge from past experience and using it to guide their future activities and decisions. How do you automate lessons learned so that they are useful and easily accessed by the right people in the organization?

K.N.: Quality Risk Management needs to be a cyclical learning process that continuously shares information throughout all stages of a product and into the next batch of the product. What can often limit an otherwise good quality program is that information obtained at the end of the product lifecycle isn’t shared with R&D. Stature ensures that all knowledge captured is available across the organization, not only to the individuals that discover it. Our reporting templates are based on our years of experience understanding what each company needs, but Stature is also configurable to how companies decide to parcel information.  Each user could configure a report template that better suits his/her needs.

PQbD: You also give clients access to libraries of information based upon other clients’ experiences. What’s the real value in this, and is there a danger in relying too much on the experiences of others?

K.N.: To be clear, we don’t share any previous client data or proprietary templates. What our libraries and risk assessment templates are based on is our years of engineering and risk management experience. Our libraries ensure that everyone in the company is speaking the same “language.” What we find within every company is that one person may account for a variance in batch processing by stating “temperature too high” while another refers to it as “overheating.” Our libraries create consistency. They begin with information that we have acquired over time but also allow companies to create their own consistent naming conventions and associated risk-ranking scales. This consistency creates efficiencies and standardizes the way companies talk about and rank certain risks.

PQbD: Finally, your promotional materials for Stature suggest that it can “enable engineering and manufacturing to align their communication and business processes by ensuring everyone is speaking the same language.” What’s the real key to making this happen in drug manufacturing organizations?

K.N.: Stature ensures that information is collected and easily shared. Many companies have multiple sites that can benefit from sharing quality information gathered, but have few reliable ways of sharing information across global sites. By using a web-deployed solution a quality professional at one plant can easily search for similar risks and mitigate them before they arise in his/her facility. In addition to the benefits of sharing information to avoid repeat issues, Stature enables collaboration by providing an awareness of other people performing similar risk assessments. Stature helps you understand who is doing similar work so that you can open a dialogue with them.