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GAMP - Quality beyond Compliance

The April 24th event provides answers to the question that the pharmaceutical industry is increasingly asking itself: 'How do we get out of this crisis in which the complexity of maintaining compliance is becoming an ever-growing financial burden?’

Is it realistic to use so many resources (people / €€ / time) for staying compliant?

One question to consider is how these priorities should be set. Does the organization, for example, seek guidance from the practices of TQM, Lean, First-time-right, Management by Objectives (MBO), (Lean)Six-Sigma, Poka-Yoke or TPS?   Or, should we first tackle the issue of 'structural integrity of data'?

Or, following the strategies of the auto industry in the 1980s, should we first thoroughly and properly address the automation of, for example, laboratories, so that the basic quality and thus also the 'structural integrity of data' is improved? How then do we ensure that this goal is achieved without ending up, once again, in an uncontrollable automation project?

The phenomenon of far-reaching automation and thus the production of enormous amounts of data has been going on for years. In view of the massive migration to AI, this trend will continue to increase.

How do we keep all this manageable and affordable for the pharmaceutical industry? How do we prioritize in a real and insightful way? And how do we get out of this crisis of compliance excellence? Company assets are not unlimited, so priorities also need to be set in this area.

These seem to be problems that are specific to the pharmaceutical industry and for this specific era. These problems are indeed widespread in the pharmaceutical industry and they are playing now.

However, these problems are not as new as it would seem at first glance. One of the founders of quality and systems thinking, W. Edwards Deming already published main elements of his theory in 1982 in a book with the appropriate title 'Out of the Crisis'. In this book, Deming bundles his more than 30 years of experience in this field. He describes how, after WW II, Japanese companies succeeded - under his leadership - in structurally coming out of the quality crisis, with a dramatic shift from compliance excellence to contextual excellence.

Because back in that era there were identical higher demands on the quality of products. And, even then, everything had to be faster and cheaper, with ever increasing quality.    What’s missing is shifting the focus on quality from compliance excellence to contextual excellence.

The fact that Dr. Deming's time-tested approach works has, in addition to years of Japanese practice, also recently has been demonstrated again at Sanofi Pasteur  (F) http://weneedsocial.com/blog/2017/6/13/deming-finally

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