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CSL Behring
Building a Quality-Focused IT Foundation for a Biopharmaceutical Enterprise
Andy Newsom
The biopharmaceutical industry continues to increase its reliance on IT systems to drive business efficiencies and growth. The key to success is to build a quality focused IT foundation to ensure compliance and effectively support the business. Important factors supporting this foundation are: a quality-minded culture, a mature IT Quality Management System (QMS) and a well-organized IT team. However, there are challenges facing IT in this quest: a changing regulatory environment, keeping up with the speed of business change, and availability of IT talent.
“We have the opportunity to be an agent of change, a catalyst for innovation and a strategic business partner that can ensure compliance and help the business achieve their critical goals”
The Foundation
The first important element of a quality-focused IT foundation is a quality-minded culture. This is often easier to achieve in manufacturing sites than in corporate offices due to the very nature of the biopharmaceutical manufacturing business. To help reinforce this culture, the IT leadership must lead by example, showing the IT team that quality is important. Establishing high-quality metrics and making them part of IT Key Performance Indicators (KPI) is also essential. In addition, leadership must provide regular education and awareness to initially develop and sustain the quality culture. A second key factor for a quality-focused foundation is a mature IT Quality Management System (QMS).
This is the documented framework that guides the actions of most work performed by IT. A solid IT QMS should be grounded on globally accepted industry standards such as GAMP 5. It is critical that an IT QMS be connected to a Learning Management System (LMS) to ensure the IT organization is properly trained on the components that are important for each IT employee to perform their job.The third element necessary to support a quality-focused IT foundation is a well-defined IT organization. Most biopharmaceutical companies are global and therefore IT must be structured in a way to support the global business. There are several IT organizational models to support a global business, but the model is not as important as one would think. What is most important is that there are clearly defined roles. Everyone must be clear on their responsibilities and understand how they fit and support the overall IT team. This well-defined and connected organization will provide a foundation to support a globally quality-focused team.
The Challenges
We face many challenges in the biopharmaceutical industry, but none greater than maintaining regulatory compliance. This includes an ever-changing regulatory environment. The regulations continue to evolve, as does technology and its interpretation by the regulators. This is why the FDA refers to their regulations as cGMP meaning “current” Good Manufacturing Practices. IT must be aware of these changes and adjust as necessary to ensure compliance with the regulations.
A second challenges is for IT to be able to work at the speed of the business and yet maintain the quality-focus. In today’s biopharmaceutical environment of shrinking margins, optimizations, mergers and acquisitions, the business has to move faster than ever before. It is essential for IT to support the business efforts and be an enabler, not an impediment. But as these pressures mount, it is normal human tendency to lose focus. A solid quality foundation is critical to ensuring focus is maintained during challenging times.
Another challenge we face in our industry is availability of IT talent and the ability to retain it. This is no different than other industry sectors, but it does make it difficult for the biopharmaceutical industry to maintain the required high standards. The reason for this is the continued growth in the global economy. As international companies continue to grow and look toward IT solutions to solve their business issues, the demand for IT talent will continue to increase.
IT will play a key role in the continued growth of the biopharmaceutical industry. We have the opportunity to be an agent of change, a catalyst for innovation and a strategic business partner that can ensure compliance and help the business achieve their critical goals. These positive results cannot be achieved without a quality-focused IT.
