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lead to loss of future revenue with business partners and have a negative regulatory consequence A recent study conducted by the Pharmaceutical Manufacturing Research Project, a joint venture by Georgetown University and Washington University in St Louis business schools, collected data from 42 manufacturing facilities owned by 19 companies to determine factors that affected industry performance The Final Benchmarking Report assessed performance in terms of manufacturing times, frequency of deviations from manufacturing standards, reasons for deviations, manufacturing yield, and rates of improvement for those metrics The study determined that improvements in manufacturing process could save industry more than $50 billion in manufacturing costs, which the researchers believe could result in lower drug prices and more money for R&D The report received no industry or government funding [3] Leadership is both challenged and rewarded for supporting the development of a robust QMS.

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Large-scale quantum computers, if they can be built, will be complex quantum systems with many parts, all of which must work together coherently to perform largescale quantum computations. To construct a large-scale quantum computer, it is not enough to exhibit components (qubits, quantum logic gates, input output devices, etc.) su cient for attaining the DiVincenzo criteria, and each of which on its own attains the limits required for fault-tolerant QC. The components of a large-scale quantum computer must be designed to t together and to work together. That is, a large-scale quantum computer must have an architecture a uni ed overall design in which each component plays an integral role. In addition, each of these components must be designed for optimal e ciency. For example, the quantum Fourier transform is a fundamental building block in all quantum algorithms, and recent work has shown that we can signi cantly enhance the performance of this component by implementing quantum circuits for the quantum Fourier transform with only logarithmic depth [631, 632].

On one hand, it takes time and resources to design and develop a comprehensive program Immediate return on this investment is not usually forthcoming Management is typically under pressure to deliver aggressive results in a short time period, which is counterintuitive to careful planning and long-range development Conversely, proactively formalizing and supporting a robust QMS will, in the long run, ensure the operations freedom to operate (regulatory compliance) and deliver business ef ciencies In the pharmaceutical and biopharmaceutical manufacturing industry, the perception of quality has dramatically changed over the past several years, and loss of market capitalization can be a direct correlation to this perception Large pharmaceutical companies have gone from some of the world s most admired companies to losing signi cant percentage of their value, based on consumer, media, and investor perceptions of quality and ethics.

Speaking at a recent Parenteral Drug Association (PDA)/FDA joint regulatory conference, Daniel Diermeier, IBM Distinguished Professor of Regulation and Competitive Practice, Northwestern University stated: The perception of quality on the pharmaceutical value chain is greater than in other industries (auto, furniture, etc) Patients cannot assess the quality of drugs as they can a car or hotel room In healthcare, the value proposition is higher than other industries and the Quality [Management] System is a critical subset of that perception [4] Dr Diermeier goes on to suggest a QMS include processes for decision and detection to further protect the value proposition of the enterprise Enterprises lacking individual capable processes experience degrees of negative effects throughout the organization This is true for processes that support discovery, development, manufacturing, or marketing Recent examples of nes imposed by regulators for poor processes supporting the QMS are increasing (see Table 2).

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