Intro -- List of Contributors -- Contents -- Introduction -- Part 1: Validation of Computerized Systems -- 1 Changes in Regulations and Regulatory Guidance Since the First Mettler-Toledo Edition -- 1.1 Data Integrity -- 1.1.1 Regulatory Authority Data Integrity Guidance Documents -- 1.1.2 Industry Data Integrity Guidance Documents -- 1.1.3 ALCOA+ Criteria for Integrity of Laboratory Data -- 1.1.4 Static and Dynamic Data -- 1.1.5 Data Integrity Guidance Summary -- 1.2 Updating EU Good Manufacturing Practice (GMP) Regulations -- 1.3 USP Analytical Instrument Qualification
1.4 GAMP 5 Guide and Validation of Laboratory Systems Good Practice Guide -- 1.5 Validation of Analytical Procedures -- 1.6 A Data Integrity Model -- 2 Instrument Qualification, Computerized System Validation and Method Validation -- 2.1 Terminology -- 2.1.1 What is a Computerized System? -- 2.1.2 Instrument Calibration and Adjustment -- 2.1.3 Analytical Instrument Qualification (AIQ) -- 2.1.4 Computerized System Validation (CSV) -- 2.1.5 Reconciling Analytical Instrument Qualification and Computerized System Validation -- 2.1.6 Different Aims of Computerized System Validation IQ and OQ
2.1.7 Future of the 4Qs Model -- 2.1.8 Analytical Method Validation (AMV) -- 2.1.9 AIQ, CSV and AMV Interrelationships -- 2.2 Apply Validated Methods Using Qualified Instrumentation -- 2.3 Distinguishing between Analytical Instrument Qualification and Method Validation -- 2.3.1 What is Done in AIQ and What is Done in AMV? -- 2.3.2 Impact of AIQ on Method Transfer -- 3 Regulatory Requirements for Computerized System Validation -- 3.1 Regulatory Agencies -- 3.2 Responsibility for Computerized System Validation -- 3.3 Regulations and Guidelines Impacting a Computerized System
3.3.1 FDA Good Manufacturing Practice (GMP) 21 CFR Part 211 -- 3.3.2 Quality System Regulation for Medical Devices: 21 CFR Part 820 -- 3.3.3 ICH Q7(R1): GMP for Active Pharmaceutical Ingredients -- 3.3.4 Electronic Records and Electronic Signatures: 21 CFR Part 11 -- 3.3.5 European Union GMP Annex 11 for Computerized Systems -- 3.3.6 FDA Guidance on General Principles of Software Validation -- 3.3.7 FDA Guidance on Computerized Systems Used in Clinical Investigations -- 3.3.8 PIC/S Guidance for Computerized Systems -- 3.3.9 Summary of Regulatory Requirements -- 3.4 ISO 17025: 2017
3.5 Warning Letters and Observations Involving Data Integrity and Computerized System -- 3.5.1 Quality Management System Failures -- 3.5.2 Instrument Citations -- 3.5.3 Citations for Lack of Laboratory Controls -- 3.5.4 Failure to Have Complete Laboratory Records -- 3.5.5 Key Data Integrity and CSV Inspection Learning Points -- 4 Computerized System Validation -- 4.1 Why Bother to Validate Your Computerized System? -- 4.2 What is Computerized System Validation (CSV)? -- 4.2.1 Principles of Computerized System Validation -- 4.2.2 Computerized System Validation Assumptions and Misconceptions
