Validation Of Chromatography Data Systems -- Contents -- List of Figures -- List of Tables -- Glosarry -- Abbreviations -- Chapter 1 How to Use this Book -- 1.1 Purpose and Scope -- 1.2 The Way It Was -- 1.3 The Way It Should Be -- 1.4 Book Structure: Life to Death of a CDS -- 1.4.1 Chapter Structure -- 1.4.2 Understanding the Basics -- 1.4.3 Planning the Work -- 1.4.4 Selecting the System -- 1.4.5 Installing and Testing the System -- 1.4.6 Support and Release of the System -- 1.4.7 Maintaining the Validation and Upgrading the System -- 1.4.8 Data Migration and System Retirement -- 1.4.9 Retrospective Validation of a CDS -- 1.4.10 Use Your Organisation's Computer Validation Policy -- 1.5 Assumptions, Exclusions and Limitations -- Chapter 2 Introduction to Chromatography Data Systems -- 2.1 What is a Chromatography Data System? -- 2.1.1 Types of Chromatography Data System -- 2.1.2 Naming Conventions -- 2.1.3 Method Files -- 2.1.4 Instrument Control Files -- 2.1.5 Sequence File -- 2.1.6 Acquisition of Chromatographic Data -- 2.1.7 Management of Data: Database or Files? -- 2.1.8 Interpretation of Chromatographic Data -- 2.1.9 System Suitability Test Calculations -- 2.1.10 Calibration -- 2.1.11 User-Defined Analytical Run Parameters -- 2.1.12 Reports and Collation of Results -- 2.1.13 Interpretation and Treatment of Chromatographic Results -- 2.2 Architecture of a Networked CDS -- Chapter 3 Regulatory Requirements for CDS Validation -- 3.1 Regulations and Guidelines Impacting a CDS -- 3.1.1 FDA Good Manufacturing Practice: 21 CFR 211 -- 3.1.2 Good Laboratory Practice: 21 CFR 58 -- 3.1.3 Quality System Regulation for Medical Devices: 21 CFR 820 -- 3.1.4 ICH Q7A: GMP for Active Pharmaceutical Ingredients -- 3.1.5 Electronic Records and Electronic Signatures: 21 CFR 11 -- 3.1.6 FDA Withdrawn Draft Guidance Documents for 21 CFR 11.

3.1.7 Current FDA Activities on 21 CFR 11 -- 3.1.8 European Union GMP Annex 11 -- 3.1.9 OECD GLP Consensus Document -- 3.1.10 FDA Guidance on General Principles of Software Validation -- 3.1.11 FDA Guidance on Computerized Systems Used in Clinical Trials -- 3.1.12 PIC/S Guidance for Computerised Systems -- 3.1.13 Summary of Regulatory Requirements -- 3.2 Warning Letters and 483 Observations Involving CDS -- 3.2.1 Gaines Chemical Company 483 Observations -- 3.2.2 Glenwood Warning Letter -- 3.2.3 Gensia Scicor Warning Letter -- 3.2.4 Noramco 483 Observations -- 3.2.5 Cordis Warning Letter -- 3.2.6 Key Inspection Learning Points -- Chapter 4 Concepts of Computer Validation -- 4.1 Why Bother to Validate Your Software? -- 4.2 What is Computerised System Validation? -- 4.3 What is a Computerised System? -- 4.4 What Computer Validation is and is Not -- 4.4.1 Principles of Computer Validation -- 4.4.2 Computer Validation Assumptions and Misconceptions -- 4.4.3 Problems with Computer Validation -- 4.5 Computer Validation, Equipment Qualification and Method Validation -- 4.5.1 Equipment Calibration and Adjustment -- 4.5.2 Equipment Qualification -- 4.5.3 Computerised System Validation -- 4.5.4 Analytical Method Validation -- 4.5.5 CSV, EQ and AMV Interrelationships -- 4.6 Life Cycle Approach to Validation -- 4.6.1 Roles of the User and Vendor -- 4.6.2 Design, Build and Test Phases of the V Model -- 4.6.3 Interpreting the SDLC Deliverables for a CDS -- 4.6.4 Time Spent per Life Cycle Stage -- 4.6.5 Relationships Between Phases of the SDLC -- 4.6.6 User and Supplier Responsibilities -- 4.6.7 Software Implementation versus Development Life Cycles -- 4.6.8 Document Controls -- 4.7 Computer Validation Roles and Responsibilities -- 4.8 Following the Corporate Computer Validation Policy -- Chapter 5 CDS Validation: Managing System Risk.

5.1 What do the Regulators Want? -- 5.1.1 EU GMP Annex 11 -- 5.1.2 FDA Guidance on Part 11 Scope and Application -- 5.1.3 FDA General Principles of Software Validation -- 5.1.4 PIC/S Guidance -- 5.1.5 Regulatory Summary -- 5.2 Do I Need to Validate the CDS? -- 5.3 How Much Validation do I do? -- 5.3.1 Balancing the Costs of Compliance and Non-Compliance -- 5.3.2 Decision Criteria for Extent of Validation -- 5.3.3 GAMP Software and Hardware Categories -- 5.3.4 GAMP Software Categories -- 5.3.5 GAMP Hardware Categories -- 5.3.6 A CDS is GAMP Category 4 with Some Category 5 Software -- 5.3.7 GAMP Best Practice Guide for Laboratory System -- 5.4 Risk Management -- 5.5 Risk Analysis Methodologies -- 5.5.1 Failure Mode Effect Analysis -- 5.5.2 Functional Risk Analysis -- Chapter 6 Process Redesign to Exploit the Tangible Benefits of Electronic Signatures with a CDS -- 6.1 What do the Regulators Want? -- 6.1.1 FDA GMP Regulations: Number of Signatures and Order of Signing -- 6.1.2 Required Laboratory Records -- 6.1.3 EU GMP and PIC/S Guidance -- 6.1.4 Regulations Summary -- 6.2 Islands of Automation in an Ocean of Paper -- 6.2.1 Current 21 CFR 11 Remediation Strategies -- 6.2.2 Rationale for Using Electronic Signatures -- 6.2.3 21 CFR 11 is an Integrated Regulation -- 6.3 Process Mapping and Analysis -- 6.3.1 Importance of Understanding the Process -- 6.3.2 Map the Current Process -- 6.3.3 Other Benefits from Redesigning the Process -- 6.4 Case Study Descriptions -- 6.4.1 Case Study 1 -- 6.4.2 Case Study 2 -- 6.5 Optimising the Workflow for Electronic Signatures - Case Study 1 -- 6.5.1 The Current Process -- 6.5.2 Basic Process Improvement Ideas -- 6.5.3 The Redesigned Process -- 6.6 Optimising the Workflow for Electronic Signatures - Case Study 2 -- 6.6.1 The Current Process -- 6.6.2 The Redesigned Process -- 6.6.3 Using the CDS for Automated Compliance.

6.7 Implementing Electronic Signatures Successfully -- 6.7.1 Understand the Process -- 6.7.2 Electronic Signatures Components -- Chapter 7 Writing the User Requirements Specification -- 7.1 What do the Regulators Want? -- 7.1.1 FDA GMP and GLP Predicate Rules -- 7.1.2 European Union GMP -- 7.1.3 FDA Draft Part 11 Validation Guidance -- 7.1.4 PIC/S Guide -- 7.1.5 General Principles of Software Validation -- 7.1.6 Regulatory Summary -- 7.2 Business Rationale for Writing a URS -- 7.3 Contents of a Chromatography Data System URS -- 7.3.1 When to Write the URS -- 7.3.2 Link the URS to a Specific Software Version -- 7.3.3 Sections of the URS -- 7.3.4 General Guidance for Writing the Requirements -- 7.3.5 URS Issues to Consider -- 7.3.6 Making the Requirements Traceable -- 7.3.7 Reviewing the URS -- 7.4 Writing Testable Requirements -- 7.4.1 How not to do it -- 7.4.2 Writing Well-Formed and Testable Requirements -- 7.4.3 Key Criteria for User Requirements -- 7.5 Documenting System Configuration and Customisation -- Chapter 8 Controlling the Work: The Validation Plan -- 8.1 What do the Regulators Want? -- 8.1.1 General Principles of Software Validation -- 8.1.2 FDA Draft 21 CFR 11 Validation Guidance -- 8.1.3 PIC/S Guidance Document -- 8.1.4 Regulatory Requirements Summary -- 8.2 What Do We Call This Document? -- 8.3 Content of the Validation Plan -- 8.3.1 Purpose of the Plan -- 8.3.2 When to Write the Validation Plan? -- 8.3.3 Project Plan and Overall Timescales -- 8.3.4 One Validation Plan for the System Life or one for Each Software Version? -- 8.3.5 Roles and Responsibilities -- 8.3.6 Validation Team Considerations -- 8.3.7 Defining Life Cycle Tasks -- 8.4 Defining a Validation Strategy for Larger CDS Systems -- Chapter 9 System Selection -- 9.1 What do the Regulators Want? -- 9.1.1 PIC/S Guidance -- 9.1.2 Regulations Summary.

9.2 Investment Protection versus Seduction by Technology -- 9.3 The System Selection Process -- 9.3.1 Generate a List of Potential Vendors -- 9.3.2 Determine Selection Criteria and Evaluation Tests Now -- 9.3.3 Prepare the Invitation to Tender/Request for Proposal -- 9.3.4 Evaluate the Vendor ITT Responses -- 9.3.5 Testing Systems Against Your Requirements -- 9.3.6 Consider User Training Now! -- 9.3.7 Visit or Talk with Existing Users -- 9.3.8 System Selection and Report -- Chapter 10 Auditing the CDS Vendor -- 10.1 What do The Regulators Want? -- 10.1.1 Draft FDA Guidance on Part 11 Validation -- 10.1.2 Preamble to 21 CFR 11 Final Rule -- 10.1.3 PIC/S Guide -- 10.1.4 EU GMP Annex 11 -- 10.1.5 Regulatory Requirements Summary -- 10.2 Rationale for a Vendor Audit -- 10.2.1 ISO 9000: Saint or Sinner? -- 10.2.2 ISO 9001 and ISO 90003 -- 10.2.3 Marketing Literature and Contracts -- 10.3 When do I Audit the CDS Vendor? -- 10.3.1 On-Site or Remote Audit? -- 10.3.2 Remote Vendor Audit -- 10.4 On-Site Vendor Audits -- 10.4.1 The Scope of an On-Site Audit -- 10.4.2 The Role of an Audit Checklist -- 10.4.3 Writing the Report -- 10.5 Audit Repository Center -- 10.6 Using the Vendor Audit to Reduce PQ Testing -- Chapter 11 Contract, Purchase Order and Planning the Installation -- 11.1 What do the Regulators Want? -- 11.1.1 EU GMP Annex 11 -- 11.1.2 Regulatory Requirements Summary -- 11.2 The Contract and Protection of Rights -- 11.2.1 Rationale for Negotiating the Contract -- 11.2.2 Overview of the Contract -- 11.2.3 Key Clauses of a Contract -- 11.3 Purchase Order: Defining the Initial Configuration -- 11.4 Preparing for System Installation -- 11.4.1 The CDS System Installation Plan -- 11.4.2 Laboratory Plan -- 11.4.3 IT Plan -- Chapter 12 Risk Assessment and Requirements Traceability -- 12.1 What do the Regulators Want? -- 12.1.1 EU GMP Annex 11.

12.1.2 FDA Guidance for Industry: Part 11 Scope and Application.