Industry healthcare

In a recent seminar, a medical expert noted that the United States has given away economic and technical dominance in industry after industry to other countries. Healthcare research is one of the few areas in which the U.S. enjoys unparalleled leadership which has enormous impact on the quality of medical care. If the healthcare industry and the academic medical enterprise falters—and this is in danger right now—I think it will be an absolute disaster for this country [40]. Many in pharmacy, medicine, and other healthcare fields would concur with the above statement. The problem is that many others in the public sector do not fully appreciate what is at stake. Pharmacists have an opportunity to help tell the story, as difficult as it sometimes is to convey. 

MED has a long history in the healthcare industry that dates back to 1877 when Erwin Mortiz Reiniger started manufacturing medical devices at the company s headquarters in Erlangen, Germany. After the discovery of the X-ray, the company successfully developed the first tube and equipment, and trend-setting innovations continued to drive the growth of the company (Table 2.1) (Mills Kurz, 2003). 

Today, with more than 7 billion in sales and 31,000 employees around the globe, MED is one of the largest suppliers to the healthcare industry (Figure 2.1). The company is known for bringing together... 

Delivering innovative solutions that meet the healthcare industry s needs... 

Simply monitoring quality performance is just not adequate. The effectiveness of quality management systems should be actively managed and performance improvement opportunities seized. Business benefits should more than compensate for any investment in quality. Senior management, system owners, project managers, and anyone else involved with computer projects need to appreciate this. This book will help explain what needs to be done to successfully achieve quality and compliance of computer systems in the pharmaceutical and healthcare industries. 

Validation is a new development. In fact, IBM established the concept of a methodology for validation for computer systems in the 1950s. Computer validation has been a requirement in the pharmaceutical and healthcare industries for about 20 years. 

Ultimately, GxP compliance protects public health. The scope of this protection exercise is enormous on average, Europeans and North Americans (including children) currently each receive in excess of ten prescription items per year and purchase six over-the-counter (OTC) medicines. In recent years the pharmaceutical and healthcare industries have avoided major public health incidents, with the notorious exception perhaps of the HIV-infected blood bank scandal in the late 1980s and early 1990s. Validation for GxP has played its part in establishing this track record. Validation for GxP has vindicated itself time after time. 

While a common methodology for computer systems validation incorporating these topics has become established within the pharmacentical and healthcare industries, the regulatory authorities continued to be disappointed with their findings in companies ... 

The lesson to the pharmacentical and healthcare industries then was that the problems identified in the high-profile incidents dted earher were continuing to occur, and that improvements were urgently needed over the entire indnstry as a whole. 

The life-cycle approach has attracted broad acceptance across the pharmaceutical and healthcare industries and can be refined to meet the needs of particular applications. Different organizations use variants of the life cycle, but the methodology of dividing a life cycle into phases remains the same. For instance some companies develop the subphases that are indicated in the phase descriptions above as distinct phases in their own right. The specific life-cycle model chosen does not really matter. Its constituent phases must, however, be clearly defined in advance, with entry and exit criteria for each phase and appropriate verification procedures to ensure the controlled completion of constituent phases. 

Figure 3.7 presents a set of life-cycle phases that summarize the validation approach typically used within the pharmaceutical and healthcare industries. Life-cycle phases may be known by alternative names in different organizations. There is no standard glossary throughout the industry relating to naming conventions or groupings of phases. It is important, however, that all the activities covered by this chapter are included in any alternative scheme. 

The various validation approaches promoted within the pharmaceutical and healthcare industries by GxP regulators and industry groups adopt the same basic approach ... 

The pharmaceutical and healthcare industry has adopted the V-Model hfe cycle for computer system projects. The validation activities are presented as a V life cycle in Figure 5.5. The V-Model was developed to promote planning and designing in anticipation of testing. Phases of the life cycle are conducted in a controlled sequence. In theory the current phase must be completed... 

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