Computer System Validation: Value Added Activities Meeting Regulatory Imperatives
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Drug Information Journal. Vol. 32. pp. 941-945. 1998 Printed in the USA. All righls reserved.
COMPUTER SYSTEM VALIDATION: VALUE ADDED ACTIVITIES MEETING REGULATORY IMPERATIVES TAMMALA D.WOODRUM, JD Senior Compliance Associate. Genentech, South San Francisco, California
This paper provides an overview of the Food and Drug Administration S embracement of computer technology. Pressing issues raised by the migration frompaper- to computerbased information systems are outlined. Regulations addressing computer validation are briefly discussed, as are the business advantages oj and the barriers to, validation. Key Words: Computer technology; Food and Drug Administration; Validation
MOST PHARMACEUTICAL AND bio- vide accurate, complete, and up to date infortechnology professionals have experienced mation in the NDA. Erroneous, partial, or the qualitative difference between making dated information can lead to faulty concluhigh risk and low risk decisions. In low risk sions and tragic results. Furthermore, in situations, one is often willing to gamble and hindsight, even faulty conclusions may be reach hasty, if not faulty, conclusions. In high defensible if they were based on comprehenrisk situations, one usually takes more time to sive, accurate, and timely information. In the modem business environment, comgather and analyze all relevant information. The Food and Drug Administration (FDA) petitive efficiency requires use of computer makes a high risk decision every time it re- systems to capture, maintain, analyze, and views a new drug application; the health and report information. The pharmaceutical and welfare of the entire United States population biotechnology industries are no exception to is at stake. The agency is asked to strike a this requirement. Although the FDA is not delicate balance. On one hand, New Drug subject to market pressure per se, other forces Application (NDA) review should weed out have pushed the agency toward embracing unsafe or inefficacious investigational prod- computer technology: ucts. On the other hand, NDA review should not be so onerous or time consuming that 1. Promulgation of the Prescription Drug otherwise safe and efficacious investigaUser Fee Act of 1992 and the FDA Modtional products are kept out of public reach. ernization Act of 1997 have provided reIn order to conduct a timely and justifiable sources and milestone goals for improving review, the agency relies on industry to prothe NDA review process and reducing total review time (1,2) (The FDA Modernization Act is available on-line at http://www. fda.gov/cdrh/modact97.pdf.), Reprint address: Tammala D. Woodrum. JD. Genentech, 1 DNA Way, Mailstop 48. South San Francisco, 2. The Federal Paperwork Reduction Act of 1995 has provided incentives for many CA 940804990. 94 1 Downloaded from dij.sagepub.com at University College London on June 5, 2016
Tammala D. Woodrurn
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Good Laboratory Practice (GLP) regulations addressing computer validation. More recently, the agency has promulgated a detailed regulation establishing cond
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