CCE Theses and Dissertations

Implications of 21 Code of Federal Regulations Part 11-Computer Validations and COTS System Testing

Date of Award


Document Type


Degree Name

Doctor of Philosophy (PhD)


Graduate School of Computer and Information Sciences


Steven D. Zink

Committee Member

Maxine S. Cohen

Committee Member

Marlyn Kemper Littman


Information technology is critical in the U.S. Food and Drug Administration's (FDA's) mission to protect and promote public health. The use of computers as tools to capture, create, store, manage, and archive information related to business operations presents a number of formidable challenges and issues relating to data and information trustworthiness and reliability for the FDA regulated pharmaceutical industry. After five years of implementation, the pharmaceutical industry has not developed a consistent interpretation of21 Code of Federal Regulations Part II and approaches to computer validation are still unclear. As of this writing, new guidelines are still being issued. In February 2003, for example, the FDA issued the Guidance for Industry Part 11, Electronic Records; Electronic Signatures-Scope and Application. The draft guidance states that Part II will be re-examined and provisions of the regulation may be revised.

Computer validation as defined by the FDA means confirmation by examination and provision of objective evidence that computer system specifications conform to user needs and intended uses, and that all requirements can be consistently fulfilled. During computer validation, testing is performed to prove that the system will capture, create, store, manage, and archive regulatory records in a reliable and trustworthy way. The challenge of meeting the FDA requirement for validation of software systems is compounded by the fact that the industry depends on Commercial Off-the-Shelf (COTS) systems. These systems are developed to provide general business solutions and market demand drives the selection of what features will be included in the software. As a result, COTS systems do not necessarily comply with the industry requirements for computer validation.

This case study analyzes COTS system testing as a computer validation key practice area and proposes a computer validation key practice model for COTS testing. In addition, the study contributes to a greater understanding of COTS testing strategies and helps shed light on the practical implications of the still-evolving federal regulation.

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