Case Study: Computer Supplier Evaluation Practices of the Parenteral Drug Association

This case study describes the development of a method for evaluating computer and software suppliers for the pharmaceutical industry. The study describes the role of government regulation within the industry and the need for standardized audits of computer and software suppliers.

The audit method consists of six steps: initiation, pre-work, auditing, observations and reporting, decision, and follow-up. Each of these steps is described in detail, as are several features of the method: a data collection tool, an audit repository, and extensive auditor training supervised by an industry-regulated oversight agency.

Finally, the report describes the benefits of this audit method, together with a set of lessons learned about the audit of computer and software suppliers.

PDF [564 KB]

Authors

David J. Carney

Harvey Greenawalt

Grigonis Grigonis

Tricia Oberndorf

This report is related to the following area(s) of work:

Case Studies

Technical Report
CMU/SEI-2003-TR-011
May 2003

Cite This Report

SEI:

Carney, David; Greenawalt, Harvey; Grigonis, Grigonis; & Oberndorf, Patricia. Case Study: Computer Supplier Evaluation Practices of the Parenteral Drug Association (CMU/SEI-2003-TR-011). Software Engineering Institute, Carnegie Mellon University, 2003. http://www.sei.cmu.edu/library/abstracts/reports/03tr011.cfm

IEEE:

D. Carney, H. Greenawalt, G. Grigonis, and P. Oberndorf, "Case Study: Computer Supplier Evaluation Practices of the Parenteral Drug Association," Software Engineering Institute, Carnegie Mellon University, Pittsburgh, Pennsylvania, Technical Report CMU/SEI-2003-TR-011, 2003. http://www.sei.cmu.edu/library/abstracts/reports/03tr011.cfm

APA:

Carney, D., Greenawalt, H., Grigonis, G., & Oberndorf, P. (2003). Case Study: Computer Supplier Evaluation Practices of the Parenteral Drug Association (CMU/SEI-2003-TR-011). Retrieved June 20, 2013, from the Software Engineering Institute, Carnegie Mellon University website: http://www.sei.cmu.edu/library/abstracts/reports/03tr011.cfm

CHI:

Carney, David, Harvey Greenawalt, Grigonis Grigonis, and Patricia Oberndorf. Case Study: Computer Supplier Evaluation Practices of the Parenteral Drug Association (CMU/SEI-2003-TR-011). Pittsburgh, PA: Software Engineering Institute, Carnegie Mellon University, 2003. http://www.sei.cmu.edu/library/abstracts/reports/03tr011.cfm

MLA:

Carney, D., Greenawalt, H., Grigonis, G., & Oberndorf, P. 2003. Case Study: Computer Supplier Evaluation Practices of the Parenteral Drug Association (Technical Report CMU/SEI-2003-TR-011). Pittsburgh: Software Engineering Institute, Carnegie Mellon University. http://www.sei.cmu.edu/library/abstracts/reports/03tr011.cfm

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