People, Paper, and Practices: How to Survive the Validation Process and Thrive on the Business Potential of Strategic Sy
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Drug Information l o u d , Vol. 33, pp. 49-61, 1999
Copyright 0 1999 Drug Information Association Inc.
Printed in the USA. All rights reserved.
PEOPLE, PAPER, AND PRACTICES: HOW TO SURVIVE THE VALIDATION PROCESS AND THRIVE ON THE BUSINESS POTENTIAL OF STRATEGIC SYSTEMS TEN STOKES,BA, MS, MT(ASCP), PHD Gxp International, Concord, Massachusetts
The Year 2000 (Y2K) “bug” has crawled into the consciousness of senior management and raised their awareness for the need to assure the quality of computerized systems. Publicity about the business opportunities on the Internet has also raised concerns about electronic crime and database security. Today’s quality assurance (QA) and systems professionals need a practical path to follow for balancing the risks and benefits of computerized systems with the business return for regulated applications. This article gives a 10-step practical path to follow for computer validation and the measurement of system quality for information technology (IT)professionals and corporate management. Key Words: Computer validation; Year 2000; Regulated systems; Good Clinical Practice; Good Laboratory Practice
as well as their ability to merge their respective computer systems. The banking industry, which has been the ultimate example of a business running on people, paper, and practices, now runs on automated tellers (ATMs), electronic records, and computerized investing. In similar manner the global pharmaceutical industry and health care providers have switched on to phone response systems, automated warehousing and dispensing, electronic review of documents, and good practices for local area networks, wide area networks. and electronic data.
INTRODUCTION THE YEAR 2000 PROBLEM for systems reading dates in two digits instead of four has become a topic of business concern and mass media discussion around the world. The United Kingdom Prime Minister Tony Blair called a special day to remind all organizations of the seriousness of preparing their computer systems to handle the date change at the millennium. The United States Federal Reserve Board, which must approve bank mergers, includes in its approval process a review of the merger candidates’ ability to handle Y2K problems
What Is Management’s Concern? Senior management is concerned about reduced risk and increased profitability for the business-critical functions using computerized systems. Management invests in new information technology with the objective of having its business thrive on the benefits of electronic speed, accuracy, and convenience
Based on a Keynote Speech presented at the DIA Workshop “Treating Validation from a System Perspective: Best Practices for System Validation,” April 15-17, 1998, Phladelpha, Pennsylvania. Reprint address: Dr. Ten Stokes, Director, Gxp International, 131 Sudbury Road, Concord, MA 01742. E-mail: [email protected].
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Teri Stokes
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facturing Practice [GMP]), and electronic recorddsubmissions. The document most easil
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