Capabilities, Measures, and Performance
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