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

Abstract

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.

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Document Details

Document Type
Technical Report
Publication Date
May 01, 2003
Accession Number
ADA416880

Entities

People

  • David J. Carney
  • George Grigonis
  • Harvey Greenawalt
  • Patricia Oberndorf

Organizations

  • Carnegie Mellon University

Tags

Communities of Interest

  • Biomedical

DTIC Thesaurus Topics

  • Acquisition
  • Auditing
  • Business Administration
  • Case Studies
  • Commerce
  • Computer Programs
  • Computers
  • Education
  • Engineering
  • Governments
  • Law
  • Lessons Learned
  • Observation
  • Software Development
  • Systems Engineering
  • Test Methods
  • Training

Fields of Study

  • Computer science

Readers

  • Defense Financial Management and Audit.
  • Industrial Economics
  • Software Engineering.