Validation of Computerized Analytical Systems

Huber, Ludwig

Introduction REGULATIONS AND STANDARDS (Current) Good Manufacturing Practice (cGMP) Regulations Good Laboratory Practice (GLP) Regulations Good Clinical Practice (GCP) Regulations Good Automated Laboratory Practices (GALP) Electronic Records and Signatures Quality Standards and Guidelines TERMINOLOGY Definition and Elements of Validation Validation versus Verification and Qualification Computer Systems and Computerized Systems Software Categories CAMP Categories Validation Processes in a Laboratory Validation Time Line Validation Strategy or Policy Validation Team Steering Committee Individual Validation Project Teams Company Validation Master Plan Individual Project Validation Plans Summary Recommendation for Validation Planning and Implementation DESIGN QUALIFICATION Recommended Steps in Design Qualification User Requirement Specifications Functional Specifications Selected Examples VENDOR ASSESSMENT Vendor Assessment Levels Criteria and Recommendations for Vendor Audits VALIDATION DURING DEVELOPMENT Development and Validation Overview Checkpoint Meetings Setting User Requirements and Functional Specifications Design Phrase Implementation Phase Testing Release for Production and Installation Operation and Maintenance Change Control Documentation INSTALLATION QUALIFICATION Preparing for Installation Installation Logbook Operator Training Documentation OPERATIONAL QUALIFICATION Selecting Tests Based on Risk Assessment Performing and Documenting Tests Example for Integrated System Testing Defining Data Files and Test Routines for Reuse Tests of Multiple Computer Systems Requalification Documentation MAINTENANCE AND ONGOING PERFORMANCE QUALIFICATION Preventative Maintenance Virus Checks Data Backup and Archiving Disaster Recovery Ongoing Performance Testing Change Control Documentation VALIDATION OF MACROS AND SPREADSHEET PROGRAMS What Should Be Validated? Planning and Setting Specifications Designing the Program Developing the Code Testing Using Spreadsheets and Macros Documentation VALIDATION OF NETWORKED SYSTEMS Definitions FDA Findings and Expectations Systems and Tasks to Be Qualified and Validated Examples of Networked Systems The Qualification/Validation Approach Using the 4Q Model Validation Master Plan and Validation Team Setting Specifications (URS, FS) Installation Testing Data Backup, Recovery, and Contingency Planning Change Control and Maintaining Security Documentation Implementation Summary COMPLIANCE WITH ELECTRONIC RECORDS AND SIGNATURES (21 CFR PART 11) Development and Current Status of the Rule Terminology Scope of Part 11 for Chromatographic Systems Workflow in Computerized Analytical Instruments Electronic Records in Chromatography Requirements of 21 CFR Part 11 Summary Recommendations for Implementation OPERATIONAL COMPLIANCE OF LEGACY SYSTEMS Regulatory Requirements, Inspection Findings, FDA's Enforcement Practices Compliance Policy and Master Plan Administrative Controls System Inventory, Gap and Risk Analysis Cost Analysis Implementation Plan Retrospective Evaluation Specific Characteristics of Older Systems Procedure for Retrospective Evaluation AUDITS Audit Findings Planning, Implementation, and Reporting Internal Audits Audit Evaluation and Reports Appendix A: Glossary Appendix B: Standard Operating Procedures Appendix C: Literature Cited Index