Validation: Never an Endpoint: A Systems Development Life Cycle Approach to Good Clinical Practice
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0092-86 15/200 I Copyright 0 2001 Drug Information Association Inc.
Printed in the USA. All rights reserved.
VALIDATION: NEVER AN ENDPOINT: A SYSTEMS DEVELOPMENT LIFE CYCLE APPROACH TO GOOD CLINICAL PRACTICE BUCKYWALSH Vice President, Systems Management
GREGA. JOHNSON Product Director PFU International, Inc., Charlottesville, Virginia
Systems development is at the beginning of its life as a scientific discipline. The pharmaceutical industry has a clear requirement to use validated systems in clinical trials. Validation cannot be regarded as a single event. A systems development life cycle methodology can integrate validation into the design and implementation of a system, matching validation activities with the life cycle of the system. PRA International, Inc. has implemented a system development life cycle developed using the Institute of Electrical and Electronic Engineers standards on software engineering as a guide. Key Words: Validation; Systems development life cycle; Institute of Electrical and Electronic Engineers; Software engineering standards
INTRODUCTION Weinberg’s Second Law-If builders built buildings the way programmers wrote programs, then the first woodpecker that came along would destroy civilization.
SYSTEMS DEVELOPMENT IS still in its infancy as a scientific discipline. This is not surprising, given the short history of computer programming. Programming was an
Based on a presentation given at the 15th Annual DIA “Symposium on Clinical Data Management,” March 16, 2000, Philadelphia, Pennsylvania. Reprint address: Bucky Walsh, PRA International, 4105 Lewis & Clark Drive, Charlottesville, VA, 2291 1-5801. E-mail: walshbucky8praintl.com.
unknown craft 50 years ago and an esoteric art 40 years ago. It was the domain of a select few initiates 30 years ago, and only entered its widespread infancy about 20 years ago. Although programming tools have been widely available to the general public for at least 10 years, this broader distribution of tools has not had a “magic effect” on the quality of the programs that are being produced. In manufacturing terms, we are on the brink of the transition to interchangeable parts. Programming as it is most often practiced is still an art, rather than a science.
VALIDATION The pharmaceutical industry operates in an environment that requires that those computer systems that are used for handling clinical trial data must be maintained in a vali-
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Bucky Walsh and Greg A. Johnson
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dated state. The International Conference on Harmonization (ICH) guideline for Good Clinical Practice states that when a computer system handles electronic trial data it is necessary to, “Ensure and document that the electronic data processing system(s) conforms to the sponsor’s established requirements for completeness, accuracy, reliability, and consistent intended performance (ie validation)” (1). Food and Drug Administration (FDA) regulations require that systems used to create, modify, maintain, o
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