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Abstract

This paper provides an overview of the Food and Drug Administration's embracement of computer technology. Pressing issues raised by the migration from paper- to computer-based information systems are outlined. Regulations addressing computer validation are briefly discussed, as are the business advantages of, and the barriers to, validation.

Keywords

Computer technology Food and Drug Administration Validation

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References

FDA Modernization Act of 1997 (S. 830–2).

Establishment of Prescription Drug User Fee Rates for Fiscal Year 1998. 62 FR 8649.

Paperwork Reduction Act of 1995 (PRA). P.L. 104–13.

Archiving Submissions in Electronic Format—NDAs. FDA Guidance For Industry, September 1997.

FDA Electronic Submission Docket 92S-0251.

Providing Regulatory Submissions in Electronic Format—NDAs. Draft FDA Guidance For Industry. April 1998.

Electronic Records; Electronic Signatures; Final Rule. 21 CFR 11.

E6 GCP: Consolidated Guideline. FDA Guidance for Industry. April 1996.

Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities; Final Policy. 56 FR 46191.

10.

FDA Regulatory Policy Manual. Chapter 10, Subchapter Application Integrity Policy. Update Number 1. March 5, 1998.

Computer System Validation: Value Added Activities Meeting Regulatory Imperatives

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