RSC Chromatography Monographs

Meeting Business and Regulatory Requirements

By: Robert McDowall

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Hardcover | 7 February 2005

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Chromatography is a major analytical technique that is used throughout research, development and manufacturing in the pharmaceutical, medical device and associated industries. To demonstrate fitness for purpose with the applicable regulations, the systems must be validated.

Validation of Chromatography Data Systems introduces the basics of computer validation. It looks in detail at the requirements throughout the life cycle of a CDS for any regulated laboratory, from its concept, through writing the user requirements specification to selecting the system, testing and operational release, including using electronic signatures. This logical and uniquely organised book provides the background to the regulatory requirements, interpretation of the regulations and documented evidence needed to support a claim that a system is validated. Development of the system, risk management, operation and finally system retirement and data migration are discussed. Case studies and practical examples are provided where appropriate.

Validation of Chromatography Data Systems is ideal for the chromatographer working in analytical laboratories in the regulated pharmaceutical, contract research, biotechnology and medical device industries seeking the practical guidance required for validating their chromatography data systems in order to meet regulatory requirements. It will also be welcomed by consultants or those in regulatory agencies.

Industry Reviews

"...pays special attention to liquid and gas chromatographs, etc, we recommend it to anyone interested in the validation of computerised systems, or those that need to perform this task, in various areas such as the regulated pharmaceutical research and medical device industries....a comprehensive over-view.....in a concisely written manner that make it a good read." * "Analytical and Bioanalytical Chemistry, (2006), 386: 1941-1942 (Kazuo Iwaki. Yuzuru Hayashi)" *

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Non-Fiction Computing & I.T.Computer Programming & Software Development Software Engineering Software Testing & Verification Science Chemistry Analytical Chemistry Chromatography Science in General

List of Figures	p. xx
List ofTables	p. xxii
Glosarry	p. xxiv
Abbreviations	p. xxvii
How to Use this Book	p. 1
Purposeand Scope	p. 1
The Way It Was	p. 2
The Way It Should Be	p. 2
Book Structure: Life to Death of a CDS	p. 2
Chapter Structure	p. 3
Understanding the Basics	p. 5
Planning the Work	p. 5
Selecting the System	p. 6
Installingand Testing the System	p. 6
Support and Release of the System	p. 7
Maintaining the Validation and Upgrading the System	p. 7
Data Migration and System Retirement	p. 7
Retrospective Validation of a CDS	p. 8
Use Your Organisation's Computer Validation Policy	p. 8
Assumptions,Exclusions and Limitations	p. 8
Introduction to Chromatography Data Systems	p. 9
What is a Chromatography Data System?	p. 9
Typesof Chromatography Data System	p. 9
Naming Conventions	p. 11
Method Files	p. 11
Instrument Control Files	p. 12
Sequence File	p. 12
Acquisition of Chromatographic Data	p. 13
Management of Data: Database or Files?	p. 13
Interpretation of Chromatographic Data	p. 13
System Suitability Test Calculations	p. 15
Calibration	p. 15
User-Defined Analytical Run Parameters	p. 16
Reports and Collation of Results	p. 17
Interpretation and Treatment of Chromatographic Results	p. 17
Architecture of a Networked CDS	p. 17
Regulatory Requirements for CDS Validation	p. 19
Regulations and Guidelines Impactinga CDS	p. 19
FDA Good Manufacturing Practice 21 CFR 211	p. 20
Good Laboratory Practice: 21 CFR 58	p. 21
Quality System Regulation for Medical Devices: 21 CFR 820	p. 22
ICH Q7A: GMP for Active Pharmaceutical Ingredients	p. 22
Electronic Records and Electronic Signatures: 21 CFR 11	p. 23
FDA Withdrawn Draft Guidance Documents for 21 CFR 11	p. 24
Current FDA Activitieson21 CFR 11	p. 25
European Union GMPAnnex	p. 1126
OECD GLP Consensus Document	p. 27
FDA Guidance on General Principlesof Software Validation	p. 27
FDA Guidance on Computerized Systems Used in Clinical Trials	p. 28
PIC/S Guidance for Computerised Systems	p. 28
Summary of Regulatory Requirements	p. 28
Warning Letters and 483 Observations Involving CDS	p. 29
Gaines Chemical Company 483Observations	p. 29
Glenwood Warning Letter	p. 29
Gensia Scicor Warning Letter	p. 30
Noramco483Observations	p. 30
Cordis Warning Letter	p. 31
Key Inspection Learning Points	p. 31
Concepts of Computer Validation	p. 33
Why Botherto Validate Your Software?	p. 33
Whatis Computerised System Validation?	p. 34
Whatisa Computerised System?	p. 35
What Computer Validation isandis Not	p. 36
Principlesof Computer Validation	p. 36
Computer Validation Assumptions and Misconceptions	p. 36
Problems with Computer Validation	p. 36
Computer Validation,Equipment Qualification and Method Validation	p. 40
Equipment Calibration and Adjustment	p. 41
Equipment Qualification	p. 41
Computerised System Validation	p. 41
Analytical Method Validation	p. 42
CSV, EQ and AMV Interrelationships	p. 42
Life Cycle Approach to Validation	p. 43
Rolesof the User and Vendor	p. 44
Design, Buildand Test Phasesof the V Model	p. 44
Interpreting the SDLC Deliverables for aCDS	p. 45
Time Spent per Life Cycle Stage	p. 47
Relationships Between Phasesof the SDLC	p. 47
User and Supplier Responsibilities	p. 48
Software Implementation versus Development Life Cycles	p. 48
Document Controls	p. 49
Computer Validation Rolesand Responsibilities	p. 50
Following the Corporate Computer Validation Policy	p. 51
CDS Validation: Managing System Risk	p. 53
What dothe Regulators Want?	p. 53
EU GMP Annex11	p. 53
FDA Guidance on Part 11 Scopeand Application	p. 53
FDA General Principlesof Software Validation	p. 53
PIC/S Guidance	p. 54
Regulatory Summary	p. 54
Do I Need to Validate the CDS?	p. 54
How Much Validation do Ido?	p. 55
Balancingthe Costs of Compliance and Non-Compliance	p. 55
Decision Criteria for Extent of Validation	p. 56
GAMP Softwareand Hardware Categories	p. 57
GAMP Software Categories	p. 57
GAMP Hardware Categories	p. 58
ACDS is GAMP Category 4withSome Category 5Software	p. 58
GAMP Best Practice Guide for Laboratory Systems	p. 59
Risk Management	p. 59
Risk Analysis Methodologies	p. 59
Failure Mode Effect Analysis	p. 60
Functional Risk Analysis	p. 60
Process Redesignto Exploitthe Tangible Benefits of Electronic Signatures witha CDS	p. 61
What dothe Regulators Want?	p. 61
FDA GMP Regulations: Numberof Signatures and Orderof Signing	p. 62
Required Laboratory Records	p. 62
EU GMP and PIC/S Guidance	p. 63
Regulations Summary	p. 63
Islandsof Automation in an Oceanof Paper	p. 63
Current 21 CFR 11 Remediation Strategies	p. 63
Rationalefor Using Electronic Signatures	p. 64
21 CFR 11 isan Integrated Regulation	p. 64
Process Mappingand Analysis	p. 64
Importance of Understandingthe Process	p. 64
Mapthe Current Process	p. 65
Other Benefits from Redesigning the Process	p. 65
Case Study Descriptions	p. 66
Case Study1	p. 66
Case Study2	p. 66
Optimising the Workflow for Electronic Signatures -Case Study1	p. 66
The Current Process	p. 66
Basic Process Improvement Ideas	p. 68
The Redesigned Process	p. 68
Optimising the Workflow for Electronic Signatures -Case Study2	p. 70
The Current Process	p. 70
The Redesigned Process	p. 70
Usingthe CDS for Automated Compliance	p. 72
Implementing Electronic Signatures Successfully	p. 73
Understandthe Process	p. 73
Electronic Signatures Components	p. 74
Writing the User Requirements Specification	p. 76
Whatdothe Regulators Want?	p. 76
FDA GMP and GLP Predicate Rules	p. 76
European Union GMP	p. 76
FDA Draft Part 11 Validation Guidance	p. 76
PIC/S Guide	p. 77
General Principlesof Software Validation	p. 77
Regulatory Summary	p. 77
Business Rationalefor Writinga URS	p. 77
Contents of a Chromatography Data System URS	p. 7
Whento Writethe URS	p. 7
Link the URS to a Specific Software Version	p. 78
Sectionsof the URS	p. 79
General Guidance for Writing the Requirements	p. 80
URS Issuesto Consider	p. 81
Making the Requirements Traceable	p. 82
Reviewingthe URS	p. 83
Writing Testable Requirements	p. 83
How not to do it	p. 84
Writing Well-Formed and Testable Requirements	p. 84
Key Criteria for User Requirements	p. 85
Documenting System Configuration and Customisation	p. 85
Controlling the Work: The Validation Plan	p. 87
Whatdothe Regulators Want?	p. 87
General Principlesof Software Validation	p. 87
FDA Draft21 CFR 11 Validation Guidance	p. 87
PIC/S Guidance Document	p. 88
Regulatory Requirements Summary	p. 88
What Do We Call This Document?	p. 89
Contentof the Validation Plan	p. 89
Purposeofthe Plan	p. 89
Whento Writethe Validation Plan?	p. 90
Project Plan and Overall Timescales	p. 90
One Validation Planfor the S ystem Life or onefor Each Software Version?	p. 91
Rolesand Respons ibilities	p. 92
Validation Team Cons iderations	p. 93
Defining Life Cycle Tasks	p. 9
Defininga Validation Strategy for Larger CDS Systems	p. 94
System Selection	p. 96
Whatdothe Regulators Want?	p. 96
PIC/S Guidance	p. 96
Regulations Summary	p. 96
Investment Protection versus Seduction by Technology	p. 9
The System Selection Process	p. 97
Generatea List of Potential Vendors	p. 97
Determine Selection Criteria and Evaluation Tests Now	p. 97
Preparethe Invitation to Tender/Request for Proposal	p. 98
Evaluate the Vendor ITT Responses	p. 99
Testing Systems Against Your Requirements	p. 100
Consider User Training Now!	p. 100
Visitor Talk with Existing Users	p. 100
System Selection and Report	p. 101
Auditing the CDS Vendor	p. 102
What do The Regulators Want?	p. 102
Draft FDA Guidance on Part 11 Validation	p. 102
Preamble to 21 CFR 11 Final Rule	p. 102
PIC/S Guide	p. 102
EUGMP Annex 11	p. 103
Regulatory Requirements Summary	p. 103
Rationalefor a Vendor Audit	p. 103
ISO 9000: Saint or Sinner?	p. 103
ISO 9001 and ISO 90003	p. 104
Marketing Literatureand Contracts	p. 105
When do I Auditthe CDS Vendor?	p. 106
On-Site or Remote Audit?	p. 106
Remote Vendor Audit	p. 106
On-Site Vendor Audits	p. 106
The Scope of an On-Site Audit	p. 107
The Role of an Audit Checklist	p. 109
Writing the Report	p. 111
Audit Repository Center	p. 111
Using the Vendor Auditto Reduce PQ Testing	p. 112
Contract,Purchase Order and Planning the Installation	p. 113
Whatdothe Regulators Want?	p. 113
EU GMP Annex	p. 11113
Regulatory Requirements Summary	p. 113
The Contractand Protection of Rights	p. 113
Rationalefor Negotiatingthe Contract	p. 113
Overviewof the Contract	p. 114
Key Clauses of a Contract	p. 116
Purchase Order: Defining the Initial Configuration	p. 117
Preparingfor System Installation	p. 117
The CDS System Installation Plan	p. 118
Laboratory Plan	p. 118
It Plan	p. 119
Risk Assessment andRequirements Traceability	p. 121
Whatdothe Regulators Want?	p. 121
EU GMP Annex	p. 11121
FDA Guidance for Industry: Part 11 Scopeand Application	p. 121
PIC/S Guidance	p. 121
FDA General Principlesof Software Validation	p. 122
Regulatory Requirements Summary	p. 122
Update the URS Before Starting the Risk Assessment	p. 122
Train Key Users	p. 122
Understandingthe New Systemor Version	p. 122
Stop Here Until You Havea Current URS	p. 123
Functional Risk Assessment	p. 123
Entry Criteria	p. 123
Risk Analysisof Individual Functions	p. 123
Deciding Whetherto Test or Not	p. 124
Traceability Matrix	p. 125
Tracing Requirements to a Specific Test Script	p. 125
How Far Should I Trace Requirements?	p. 126
Further Tracingof Requirements	p. 126
Installation Qualification andOperational Qualification	p. 127
Whatdothe Regulators Want?	p. 127
EU GMP Annex	p. 11127
PIC/S Guidance	p. 127
General Principlesof Software Validation	p. 128
Regulatory Summary	p. 128
Terminology: Gettingit Right	p. 128
Equipment Qualification	p. 128
Computerised System Validation	p. 129
Reconciling Equipment Qualification and Computer Validation	p. 130
Different Aims of Computer Validation IQ and OQ	p. 131
Installation Qualification	p. 132
Establish the Initial CDS Configuration Baseline Now	p. 133
Operational Qualification	p. 133
Contents of an Operational Qualification Package	p. 133
Assess the Vendor's Qualification Documentation	p. 134
Documenting System Configuration and Customisation	p. 135
Performance Qualification (PQ) or End-User Testing	p. 136
Whatdothe Regulators Want?	p. 136
EUGMP Annex	p. 11136
FDA General Principlesof Software Validation	p. 136
Draft Part 11 Validation Guidance	p. 137
Regulatory Requirements Summary	p. 138
Principlesof Software Testing	p. 138
Testing Approach	p. 139
Typesof Software Testing	p. 139
Test Approach: White Box or Black Box Testing?	p. 140
Manualor Automated Testing?	p. 141
Planning Whatto Test	p. 141
New Data System Features? Update the URS!	p. 142
PQ Test Plan	p. 142
Tracing User Requirements to PQ Testing	p. 143
Assumptions,Exclusions andLimitationsof the Test Approach	p. 144
PQ Test Scripts	p. 144
Featuresto Test inany CDS System	p. 145
Writethe Test Scripts	p. 146
Outline Test Case Design	p. 148
Defining, Documentingand Testing System Security	p. 149
Isthe Requirement You Are Testing Specified?	p. 150
Designingthe Tests	p. 151
Risk Analysis: Extent of Testing?	p. 152
Refining the Test Design	p. 152
PQ Test Documentation	p. 153
Key Test Script Sections	p. 153
Documenting Test Execution Instructions and Expected Results	p. 153
Writing Observed Results	p. 155
Unexpected Results	p. 155
Suggested Documentation	p. 156
Documenting Observed Results	p. 157
Collating Documented Evidence	p. 157
Hasthe Test Passed or Failed?	p. 157
Some Considerations for Testing Electronic Signatures	p. 157
User Trainingand System Documentation	p. 159
Whatdothe Regulators Require?	p. 159
EU GMP Annex	p. 11159
FDA 21 CFR 211 GMP	p. 159
FDA 21 CFR 58 GLP	p. 160
Regulatory Requirements Summary	p. 160
Personneland Training Records	p. 160
System Documentation	p. 161
CDS Vendor Documentation	p. 161
Laboratory Standard Operating Procedures	p. 162
Checking the SOPs during the PQ	p. 163
Administrativeand Procedural Controls Required for 21 CFR 11 Compliance	p. 163
IT Support of the System	p. 166
What dothe Regulators Want?	p. 166
21 CFR 11	p. 166
EUGMP Annex	p. 11166
PIC/S Guidance	p. 167
FDAGMP 21 CFR 211	p. 167
483 Observations and Warning Letters	p. 167
Regulatory Requirements Summary	p. 167
Service Level Agreement	p. 167
Backup and Recovery	p. 168
Business Rationale: How Important are Your Data?	p. 168
Whatis Backup and Recovery?	p. 168
Rolesand Responsibilities	p. 168
Hardware to help Data Security and Integrity	p. 170
Optionsto Considerfor Backup	p. 171
Main Backup Activities	p. 172
Hot or Cold Backups?	p. 172
Cold Backups	p. 173
Hot Backups	p. 173
Media Management	p. 174
Restoring Data from Tape	p. 174
Timeand Date Stamps	p. 175
FDA Guidance on Time Stamps	p. 175
Time Stamps for Standalone CDS Systems	p. 175
Time Stamps for Networked CDS Systems	p. 176
System Description	p. 177
What dothe Regulators Want?	p. 177
EUGMP Annex	p. 11177
OECD Application of GLP Principlesto Computerised Systems	p. 177
PIC/S Guidance	p. 178
Regulatory Requirements Summary	p. 178
Turning Regulations into Practice	p. 178
Single Document or Multiple Documents?	p. 178
Outlinefor a System Description	p. 179
Keeping Current: Updating the System Description	p. 179
Key Sectionsof the System Description	p. 180
Introduction	p. 180
System Scope	p. 180
Definition of Electronic Records!	p. 81
Validation Summary Report	p. 182
What dothe Regulators Want?	p. 182
PIC/S Guidance	p. 182
General Principlesof Software Validation	p. 182
Regulatory Requirements Summary	p. 183
Content of the Validation Summary Report	p. 183
Writingthe Validation Summary Report	p. 183
How to Summarise the Work	p. 183
How to Summarise PQ Testing	p. 184
PQ Test Execution Notes	p. 185
Deviations from the Plan	p. 186
Validation Package	p. 186
Releasing the System	p. 186
Going Live! Sit Back and Relax?	p. 187
Defining Electronic Records for a CDS	p. 188
What dothe Regulators Want?	p. 188
21 CFR 11	p. 188
FDA Part 11 Scopeand Application Guidance	p. 188
Regulatory Requirements Summary	p. 189
Literature Contributions to the E-Records Debate	p. 189
Furman,Tetzlaffand Layloff (1994)	p. 189
BARQA	p. 189
Non-compliant Working Practices	p. 190
Culture Shock: Changingfrom Paperto Electronic Records	p. 190
Meta-Data	p. 191
Back inthe Lab	p. 191
Data Organisation	p. 192
Instrument Control and Calibration	p. 193
Setting Up an Analytical Run	p. 194
Run Samples and Acquire Data	p. 194
Interpreting the Data Files	p. 195
Post-run Calculations and Reporting	p. 195
Do You Use Macros?	p. 195
Audit Trail Entries	p. 196
Diode Array Detectors	p. 196
Controlled Chromatographwith Separate Data System	p. 197
Define the Electronic Records for Your System	p. 197
Maintaining the Validation Status During Operational Life	p. 199
What dothe Regulators Want?	p. 199
FDA GMP Predicate Rule Requirements	p. 199
EU GMP Annex 111	p. 99
PIC/S Guidance for GXP Systems	p. 199
OECD GLP Consensus Document on Computerised Systems	p. 200
Regulatory Requirements Summary	p. 201
Change Control and Configuration Management	p. 202
Definition of Terms	p. 202
Is it a Change or Normal Operation?	p. 202
Change Control Process	p. 203
Discussion of Some TypicalSystem Changes	p. 206
Emergency Changes	p. 207
Configuration Management	p. 207
Defining the Detailof Configuration Items	p. 207
Defining the System Baseline Configuration	p. 208
Linking Configuration Management with Change Control	p. 209
Operational Proceduresand Records	p. 209
Problem Recordingand Recovery	p. 209
Software Error Loggingand Resolution	p. 209
Maintenance Records	p. 210
Disaster Recovery or Business Continuity Plan	p. 210
Periodic Reviewof the CDS	p. 212
What dothe Regulators Want?	p. 212
PIC/S Guidance	p. 212
ICH Q7 AGMP for Active Pharmaceutical Ingredients	p. 213
Regulatory Requirements Summary	p. 213
Rationalefor a Periodic Review	p. 213
Who Performs the Review?	p. 213
How Often Shouldthe Review Occur?	p. 214
Overviewofthe Periodic Review Process	p. 214
Periodic Review Objective	p. 214
Planning the Audit	p. 214
Schedulefor the Review	p. 215
Scope of the Review	p. 215
Reporting the Review and Follow-up	p. 217
Confidentiality of the Periodic Review Report	p. 217
Records Retention	p. 218
Whatdothe Regulators Want?	p. 218
GLP Regulations: 21 CFR 58	p. 218
GMP Regulations: 21 CFR 211	p. 218
GMP Regulations: 21 CFR 820	p. 219
21 CFR 11 Requirements	p. 219
Part 11 -Scopeand Application Guidance	p. 219
FDA Inspection of Pharmaceutical Quality Control Laboratories	p. 220
OECD GLP Consensus Document	p. 220
Regulatory Requirements Summary	p. 220
Impactofthe Lack of Universal CDS Data Standards	p. 221
Optionsfor Electronic Records Retention and Archive	p. 221
Archiveis Different from Backup	p. 221
Organising CDS Electronic Recordsto Archive	p. 222
Optionsfor Electronic Archive	p. 222
Can I Read the Records?	p. 223
Impact of a Changed CDS File Format	p. 224
Selection of Off-Line Archive Media	p. 225
Changing CDS -Whatarethe Archive Options?	p. 225
Overviewof Some Options	p. 225
Assessment of Option Feasibility	p. 226
CDS Data Migration	p. 227
Whatdothe Regulators Want?	p. 227
Business Rationalefor Data Migration	p. 227
Drivers for Data Migration and System Retirement	p. 228
Internal Drivers	p. 228
External Drivers	p. 228
Data Migration Options	p. 229
Data Migration between Different Applications	p. 229
Data Migration withinan Application	p. 230
Validation ofwithin Application Data Migration	p. 230
Generic Data Migration and System Retirement Process	p. 230
Roleofthe System Ownerand Senior Management	p. 230
Step1: Inventoryof the System	p. 231
Step2: Carry out a Risk Assessment	p. 231
Step3: Writethe Retirement Plan	p. 232
Step4: Detailed Information Gathering	p. 232
Step5: System Decommissioningand Data Migration Plan	p. 232
Step6: Execute Workand Document Activities	p. 232
Step7: Write Retirement and Migration Report	p. 232
Case Studyof Data Migration	p. 233
Designofthe Overall Validation Project	p. 233
Overviewofthe Mass Spectrometry Systems	p. 233
Mass Spectrometry Equipment	p. 234
Data Acquisition and Processing Software Applications	p. 234
Computing Environments	p. 234
Differencesbetweenthe Two CDS Systems	p. 235
Data Migration Strategy	p. 236
Vendor Supplied Data Conversion Utilities	p. 236
Limitationof the Data Conversion Utilities	p. 236
Data Migration Options	p. 237
Evolutionof the Data Migration Design	p. 237
Designofthe Overall Data Migration and System Retirement	p. 237
Data Migration: Key Results	p. 238
Retention Time	p. 238
Instrument Control Parameters	p. 239
Integration Algorithms and Calculated Results	p. 239
History Logs	p. 240
Data Migration Summary	p. 241
CDS System Retirement	p. 243
Whatdothe Regulators Want?	p. 243
Generic Process for System Retirement	p. 243
Notification of System Retirement	p. 243
Involvement of Quality Assurance and it	p. 244
Cessation of Work	p. 245
Shutdownofthe System	p. 245
Documenting Retirement and Disposal	p. 245
Case Studyof System Retirement	p. 246
Retrospective Validation	p. 248
Whatdothe Regulators Want?	p. 248
PIC/S Guidance	p. 248
Regulatory Requirements Summary	p. 249
Literature Referencesto Retrospective CDS Validation	p. 249
Gapand Planfor Retrospective Validation	p. 249
Collect Existing Documentation	p. 249
Review Existing Documents	p. 250
Planningto Bridge the Gap	p. 251
Management Underwritethe Plan	p. 251
References	p. 253
Table of Contents provided by Publisher. All Rights Reserved.

RSC Chromatography Monographs

Meeting Business and Regulatory Requirements

Industry Reviews

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Defective items

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