Capabilities, Measures, and Performance

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Authors: Guy Wingate
Cited by: 0
References: 2

Abstract

The ability to perform cost-effective compliance is dependent on the organization’s understanding of requirements and their compliance capability. This chapter applies a variation of the Carnegie Mellon University’s capability maturity model (CMM) to computer compliance. This maturity model has been successfully applied to organizations implementing project-based waterfall, Agile, and hybrid development methodologies. Examples of compliance metrics and measures for projects using the waterfall development methodology are examined first to draw lessons. Metrics for projects adopting the Agile development methodology are then discussed. Metrics covered include prospective validation as well as operation and maintenance of computer systems. Lean manufacturing and six sigma are promoted as tools that organizations can use to streamline and improve the performance of their compliance processes.

Fields of Study & Subjects

Efficiency Analysis Using DEA Software System Performance and Reliability Accounting and Organizational Management

Publication details

Journal / source
Pharmaceutical Computer Systems Validation
Publisher
CRC Press
Pages
425–447
Publication date
23 April 2026
Language
EN
Document type
Book chapter