This column is adapted from the book Universal Meta Data Models by David Marco & Michael Jennings, John Wiley & Sons, 2004.
In the first two parts of this series, I walked through examples in the banking, healthcare insurance and manufacturing industries. This month I will address managed meta data environment (MME) applications for national defense and pharmaceutical industries.
National defense organizations such as the FBI, the U.S. Army, Navy, Air Force, Marines, Coast Guard and Britain's Royal Navy have some of the most extensive MME requirements of any type of organization. These groups are absolutely dependent on the information from their systems and the proper functionality of their immense IT applications. This is doubly important to understand because the activities that these organizations engage in place people in harm's way. Our application scenario maps the IT system's data elements to the functional information elements for interfaces between the major IT systems.
A key task of the National Security Organization is to deliver medical supplies to various theaters of operation. They want to see which branches of the military utilize what interfaces and elements to accomplish this task (see Figure 1). This type of report is highly valuable when problems or enhancements need to be resolved or made across the IT systems.
Pharmaceutical companies tend to have more sophisticated MME and data stewardship committees because of the regulations around clinical trials. Clinical trials are the processes a pharmaceutical company goes through to research, develop and attain government approval for new compounds (drugs). The average cost for developing a new drug is between $150 to $250 million and more than 10 years of time before it can be brought to market. Every day that a new compound is delayed from reaching the market costs the company $1 million in lost revenue. This includes the extra time it will take to recoup sunk expenses (ever see the interest expense on $150 million?) and the possibility of a competitor creating a competing compound.
During these trials, government agencies such as the FDA have rigorous standards that must be met before a new drug can gain approval. Passing these FDA (and other agency requirements) tests is not easy. These organizations and their corresponding legislation require that a pharmaceutical company has very definitive data elements. For example, Title 21 CFR Part 11 has a significant impact on a clinical trial for a pharmaceutical company. Look at the following passage from the FDA Department of Health and Human Services, entitled "Title 21 CFR Part 11, Electronic Records; Electronic Signatures; Final Rule" dated Thursday March 20, 1997:
"The Food and Drug Administration (FDA) is issuing regulations that provide criteria for acceptance by FDA, under certain circumstances, of electronic records ... the pharmaceutical industry met with the agency to determine how they could accommodate paperless record systems ... to develop a uniform approach by which the agency could accept electronic signatures and records in all program areas ... The final rule provides criteria under which the FDA will consider electronic records to be equivalent to paper records, and electronic signatures equivalent to traditional handwritten signatures."
Compliance with FDA regulations such as this is no small task, and almost every pharmaceutical company is struggling to adhere to this regulatory rule. This rule will be the focus point of our application scenario.
TheGreatPharma Company is a large pharmaceutical company that is running a clinical trial on a new compound. In order to pass various Title 21 CFR Part 11 audit compliance regulations, they must track every instance where a person changed any data within the clinical trial. The meta data captured in this process includes what data was changed, who changed it, when was it changed, what its prior value was, what its new value is and why it was changed. The audit compliance report shown in Figure 2 could be generated directly form the MME and provided to the FDA to assist in expediting the process of FDA approval.
In my next column I will conclude this series on specific industry examples of how an MME can provide value to any large government or commercial organization.
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