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E-raamat: Data Integrity in Pharmaceutical and Medical Devices Regulation Operations: Best Practices Guide to Electronic Records Compliance

  • Formaat: 394 pages
  • Ilmumisaeg: 03-Nov-2016
  • Kirjastus: Productivity Press
  • Keel: eng
  • ISBN-13: 9781498773263
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Data Integrity in Pharmaceutical and Medical Devices Regulation Operations: Best Practices Guide to Electronic Records ComplianceSuurem pilt
  • Formaat: 394 pages
  • Ilmumisaeg: 03-Nov-2016
  • Kirjastus: Productivity Press
  • Keel: eng
  • ISBN-13: 9781498773263
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Data Integrity is fundamental in a pharmaceutical and medical devices quality system which ensures that they are of the required quality. This book provides practical information to enable compliance with data integrity, while highlighting and efficiently integrating worldwide regulation into the subject. The ideas presented in this book are based on many years experience in the US Department of Defense and regulated industries in various computer systems development, maintenance, and quality functions. In addition to case studes, a practical approach will be presented to increase efficiency and to ensure that the design and testing of the data integrity controls are correctly achieved.

Foreword xiii
Preface xv
Authors xix
Contributors xxi
1 Introduction
1(4)
Additional Readings
4(1)
2 Inspection Trends
5(34)
Additional Readings
37(2)
3 Electronic Records Life Cycle
39(8)
Introduction
39(1)
Creation
40(1)
Access, Use, and Reuse
40(2)
Migration
42(1)
Transformation
42(1)
Physical Deletion
43(1)
E-Records and Computer Systems Life Cycles
44(1)
Additional Readings
45(2)
4 Electronic Records Related Definitions
47(12)
Introduction
47(1)
Data Terminology
48(3)
Introduction to Automated Manufacturing System
51(2)
How Are MHRA Definitions Applicable?
53(2)
Primary Records
55(1)
Records Retention on Raw Data
55(1)
Summary
56(1)
Additional Readings
57(2)
5 Electronic Records Handling: 21 CFR Part 211
59(4)
Introduction
59(1)
Access Authorization Principles
60(1)
Data Input/Output Principles
61(1)
Data Storage and Backup Principles
61(1)
Accuracy Check
62(1)
Additional Readings
62(1)
6 Electronic Records Handling: EMA Annex 11
63(14)
Introduction
63(1)
Creation
64(1)
Access, Use, and Reuse
65(4)
Physical Deletion
69(1)
Controls Based on System Life Cycle
69(6)
Additional Readings
75(2)
7 Relevant Worldwide GMP Regulations and Guidelines
77(24)
Introduction
77(1)
API
78(8)
GMP
86(13)
Additional Reading
99(2)
8 Trustworthy Computer Systems
101(20)
Introduction to Trustworthy Computer Systems
102(1)
Computer Systems Suited to Performing Their Intended Functions
103(2)
ISO 9000-3
105(1)
US FDA
105(2)
European Medicines Agency (EMA) Annex 11, Therapeutic Goods Administration (TGA), and China's SFDA
106(1)
PIC/S PI-011-3, Association of Southeast Asian Nations (ASEAN), and Canadian HPFBI
106(1)
International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
107(1)
World Health Organization (WHO)
107(1)
Japanese MHLW
107(1)
Brazil ANVISA
107(1)
Provide a Reasonably Reliable Level of Availability, Reliability, and Correct Operation
107(4)
ISO 9000-3
109(1)
US FDA
109(1)
EMA and TGA
109(1)
PIC/S PI-011-3, ASEAN, and Canadian HPFBI
110(1)
ICH
110(1)
WHO
110(1)
China SFDA
110(1)
Brazil ANVISA
111(1)
Secure from Intrusion and Misuse
111(3)
ISO 9000-3
112(1)
US FDA
112(1)
EMA, TGA, and China SFDA
112(1)
PIC/S PI-011-3, ASEAN, and Canadian HPFBI
112(1)
ICH
113(1)
WHO
113(1)
Brazil ANVISA
113(1)
Adhere to Generally Accepted Security Principles
114(2)
Trustworthy Computer Systems Infrastructure
116(2)
Computer System Procedures
118(1)
Summary
118(1)
Additional Readings
119(2)
9 MHRA Guidance
121(12)
Introduction
121(2)
Data Governance
123(1)
Computer Systems Validation
124(1)
Requirements
125(1)
Risk Assessment
126(3)
Data Migration and Computer Systems Release to Operations
129(1)
Operations
130(1)
Computer System Retirement: E-Records Migration
131(1)
E-Records Archiving
132(1)
E-Records Destruction
132(1)
Additional Reading
132(1)
10 Electronic Records Governance
133(10)
Introduction
133(2)
E-Records Integrity Strategy
135(1)
E-Records Integrity Policy
136(1)
E-Records Integrity Plan
136(2)
E-Records Integrity Procedural Controls
138(1)
E-Records Integrity Guidelines
138(1)
Organization
138(3)
E-Records Repository Inventory
139(1)
Training
139(1)
Enforcement
140(1)
Additional Reading
141(2)
11 Procedural Controls for Handling E-Records
143(14)
Introduction
143(1)
E-Records Integrity Procedural Controls
144(3)
Other Related Procedural Controls: Operational Activities
147(6)
Archiving
148(1)
Backups
148(1)
Business Continuity
149(1)
E-Records Quality Control
149(1)
E-records Storage
150(1)
Infrastructure Maintenance
150(1)
Problem Reporting
151(1)
Problem Management
151(1)
Retirement
151(1)
Restore
152(1)
Risk Management
152(1)
Security
152(1)
Training
153(1)
Other Related Procedural Controls: Maintenance Activities
153(2)
Verification and Revalidation
153(1)
Change Control
154(1)
Checks
154(1)
Additional Readings
155(2)
12 Electronic Record Controls: Supporting Processes
157(12)
Business Continuity
157(1)
Incident Management
158(1)
Periodic Reviews
158(1)
Personnel
159(1)
Requirements Document
159(1)
Risk Management
160(2)
Security
162(4)
Suppliers and Service Providers
166(1)
Timestamping Controls
166(1)
Additional Readings
167(2)
13 Electronic Records Controls: Records Retained by Computer Storage
169(10)
Introduction
169(1)
E-Records Archiving
170(2)
E-Records Migration
172(1)
E-Records Storage
173(2)
File Integrity Checking
175(1)
E-Records Handling
176(1)
Additional Readings
177(2)
14 Electronic Record Controls: During Processing
179(6)
Archiving
179(1)
Audit Trails
179(2)
Built-In Checks
181(1)
Electronic Signature
181(1)
Operational Checks
181(1)
Printouts/Reports
182(2)
Security
184(1)
15 Electronic Record Controls: While in Transit
185(4)
Qualification of IT Infrastructure
185(1)
Built-In Checks
186(2)
Accuracy Checks
188(1)
16 Electronic Records and Contract Manufacturers
189(4)
Additional Readings
191(2)
17 Electronic Records and Cloud Computing
193(8)
Additional Readings
199(2)
18 Self-Inspections
201(6)
Introduction
201(1)
E-Records Self-Inspections
202(2)
E-Records Remediation
204(1)
Additional Reading
205(2)
19 Electronic Records Remediation Project
207(6)
Evaluate E-Records Controls
208(1)
Corrective Action Planning
209(1)
Remediation
210(2)
Interpretation
211(1)
Training
211(1)
Remediation Execution
211(1)
New Applications and Application Upgrade Assessments
212(1)
Suppliers Qualification Program
212(1)
Remediation Project Report
212(1)
Additional Reading
212(1)
20 Summary
213(6)
Appendix I 219(32)
Appendix II 251(4)
Appendix III 255(18)
Appendix IV 273(16)
Appendix V 289(10)
Appendix VI 299(22)
R.D. Mcdowall
Appendix VII 321(20)
M. Roemer
Appendix VIII 341(12)
Appendix IX 353(4)
Appendix X 357(8)
Index 365
Orlando Lopez

E-records Integrity SME

Durham North Carolina USA

Orlando Lopez has significant understanding and experience with worldwide regulatory authorities regarding CSV, e-records integrity, and related requirements/guidelines related to Production Manufacturing Systems, IT Systems, Analytics, and Business Intelligence.

He has knowledge and experience in the development of governance and SLC deliverables. Wrote and deployed CSV methodology to computer infrastructure J&J worldwide. Several times he had re-engineered the computer validation methodology to regulated companies.

Orlando Lopez has experience with direct participation in FDA agency remedial action plans, regulatory inspections, response activities, and consent decree remediation related verifications.

He is published in the Encyclopedia of Pharmaceutical Science and Technology, 4th Edition - Chapter 56 Computer Systems Validation (Taylor & Francis Group, LLC) and had written 25+ publications, including 9 computer compliance related books - amazon.com/author/orlandolopez/

Familiar with gap assessment, remediation planning and remediation execution activities.
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