"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."
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