Ludwig Huber
Validation of Computerized Analytical Systems
Ludwig Huber
Validation of Computerized Analytical Systems
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Covering the entire validation process, from writing a validation plan through implementation, testing, and installation qualification, to ongoing calibration, performance qualification, and change control, this book provides readers with complete validation details. It discusses international and FDA regulations with numerous practical examples that show readers how to accomplish validation acceptable to FDA GCP/GLP/GMP, NAMAS, and EN45001 standards both cost effectively and efficiently. The templates included supply documentation examples and the checklists assure readers that all aspects of their validation are covered in logical sequence.…mehr
Covering the entire validation process, from writing a validation plan through implementation, testing, and installation qualification, to ongoing calibration, performance qualification, and change control, this book provides readers with complete validation details. It discusses international and FDA regulations with numerous practical examples that show readers how to accomplish validation acceptable to FDA GCP/GLP/GMP, NAMAS, and EN45001 standards both cost effectively and efficiently. The templates included supply documentation examples and the checklists assure readers that all aspects of their validation are covered in logical sequence.
Produktdetails
- Produktdetails
- Verlag: Bsp Books Pvt. Ltd.
- Seitenzahl: 268
- Erscheinungstermin: 7. Oktober 2019
- Englisch
- Abmessung: 254mm x 178mm x 14mm
- Gewicht: 472g
- ISBN-13: 9780367401726
- ISBN-10: 036740172X
- Artikelnr.: 58314049
- Verlag: Bsp Books Pvt. Ltd.
- Seitenzahl: 268
- Erscheinungstermin: 7. Oktober 2019
- Englisch
- Abmessung: 254mm x 178mm x 14mm
- Gewicht: 472g
- ISBN-13: 9780367401726
- ISBN-10: 036740172X
- Artikelnr.: 58314049
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
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
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
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