ABSTRACT
Introduction: Twenty Frequently Asked Questions . . . . . . . . . . . . . . . . . . . . . . 168 Q1 What Is Computer Validation? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168 Q2 How and by Whom Are Computer Systems Validation Activities
Regulated? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169 Q3 Who Is Responsible for Validating Computer Systems? . . . . . . . . . . . . 169 Q4 Why Do Customers Conduct Audits? . . . . . . . . . . . . . . . . . . . . . . . . . . 170 Q5 Is There a Standard Audit Process?. . . . . . . . . . . . . . . . . . . . . . . . . . . . 170 Q6 When Is an Audit Required?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 171 Q7 What Is the Scope of an Audit? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 171 Q8 What about Electronic Records and Electronic Signatures? . . . . . . . . . 175 Q9 Who Conducts the Audit?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 176 Q10 How Will the Audit Be Conducted? . . . . . . . . . . . . . . . . . . . . . . . . . . . 176 Q11 When and How Will Suppliers Be Contacted in Regard to
an Audit? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 177 Q12 What Happens in a Quality Review? . . . . . . . . . . . . . . . . . . . . . . . . . . 178 Q13 What Happens in a Postal Audit? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 178 Q14 What Happens in a Full Supplier Audit?. . . . . . . . . . . . . . . . . . . . . . . . 179 Q15 What Happens after an Audit? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 180 Q16 Are Audit Reports Confidential? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 181 Q17 Can a Regulator Such as FDA or MHRA Inspect a Supplier? . . . . . . . . 181 Q18 Can Suppliers Be Approved by Regulators? . . . . . . . . . . . . . . . . . . . . . 182 Q19 What Is an Escrow Account? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 182 Q20 Where Can I Get More Guidance and Advice? . . . . . . . . . . . . . . . . . . . 183 Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183 Terminology in Brief. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 184 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 184 Appendix A ISO 9000 Clauses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 184 Appendix B Supplier Audit Postal Questionnaire . . . . . . . . . . . . . . . . . . . . 185 Appendix C Full Supplier Audit Checklist . . . . . . . . . . . . . . . . . . . . . . . . . 188 Appendix D Checklist for Customer Audits. . . . . . . . . . . . . . . . . . . . . . . . . 192
INTRODUCTION: TWENTY FREQUENTLY ASKED QUESTIONS
This chapter is intended for users and suppliers involved in the auditing of computer systems, software, and associated services to the pharmaceutical and healthcare industries.
