Preface
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
Appendices
Appendix A: Glossary
Appendix B: Bibliography
Index
Biography
International Validation Forum
