1st Edition

Validation Compliance Annual 1995

By International Validation Forum Copyright 1995
    1110 Pages
    by CRC Press

    "Offers an overview of validation and the current regulatory climate and provides a compendium of the regulations, guidance documents, issues, compliance tools, terminology, and literature involved in computer systems validation. Thoroughly examines regulations issued by the U.S. Food and Drug Administration, the U.S. Environmental Protection Agency, and the European Union. Furnishes case studies of real-world situations."


    Section I: Overview

    Behind Validation

    The Regulatory World

    Section II: Government Regulation

    FDA Regulations

    EPA Regulations

    European Union Regulations

    Section III: Situational Review

    Situational Review by Industry

    Situational Review in the U.S.S

    International Situational Review

    Section IV: Tools for Validation

    Validation Checklist

    The Use of an SDLC in System Validation

    Data Integrity and Security

    Documentation: The SOP

    Electronic Signatures

    Drug Inspections

    Biologics Inspections

    Medical Device Inspections

    Hazard Analysis

    Section V: Field Findings

    FDA Adverse Findings

    Case Study Experience: Sixteen Theses

    Section VI: Future Developments

    Future Developments


    Appendix A: Glossary

    Appendix B: Bibliography



    International Validation Forum