Muutke küpsiste eelistusi

21 CFR Part 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry [Kõva köide]

  • Formaat: Hardback, 260 pages, kõrgus x laius: 254x178 mm, kaal: 612 g, 10 Tables, black and white; 40 Illustrations, black and white
  • Ilmumisaeg: 15-Jan-2004
  • Kirjastus: CRC Press Inc
  • ISBN-10: 084932243X
  • ISBN-13: 9780849322433
Teised raamatud teemal:
21 CFR Part 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical IndustrySuurem pilt
  • Formaat: Hardback, 260 pages, kõrgus x laius: 254x178 mm, kaal: 612 g, 10 Tables, black and white; 40 Illustrations, black and white
  • Ilmumisaeg: 15-Jan-2004
  • Kirjastus: CRC Press Inc
  • ISBN-10: 084932243X
  • ISBN-13: 9780849322433
Teised raamatud teemal:
Püsilink: https://www.kriso.ee/db/9780849322433.html
Märksõnad:
This guide delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance with FDA regulations related to international computer validation in the pharmaceutical industry. The guide shows how to comply with computer systems validation requirements, while highlighting and integrating Part 11 requirements into the entire computer validation program. Regulatory compliance is placed within the context of quality assurance, and the importance of integrating validation into the system life cycle using a structured top-down approach is stressed. Information is applicable to computer systems for pharmaceuticals, cosmetics, food, and medical device applications. Annotation ©2004 Book News, Inc., Portland, OR (booknews.com)
Foreword ix
Sion Wyn
Preface xi
Orlando Lopez
Publisher's Note xiii
Dedication xv
Introduction
1(4)
Validation Overview
5(8)
What Is a Computer System?
5(1)
What Is a Computer Systems Validation?
5(1)
Why Do We Validate Computer Systems?
6(2)
Key Project Elements
8(1)
Which Systems Should Be Validated?
8(1)
Introduction to the Computer Systems Validation Process
9(2)
Computer Systems Validation for Low Criticality and/or Low Complexity Projects
11(2)
USA Regulatory Requirements for Computer Systems
13(8)
Medical Devices Software
17(1)
The Food Industry
18(3)
New Computer Systems Validation Model
21(4)
Computer Validation Management Cycle
25(4)
Validation Policies
26(1)
Validation Guidelines
26(1)
Validation Plans
27(1)
Procedural Controls
27(1)
Compliance Assessments
27(1)
Validation of Computer Systems
27(1)
Supplier Qualification
27(1)
Ongoing Support Systems
27(2)
Computer Validation Program Organization
29(6)
Organizational Model
29(1)
Computer Systems Validation Executive Committee
30(1)
CSV Cross-Functional Team
30(1)
CSV Groups and Teams
31(1)
The Management Group
32(1)
Validation Program Coordinators
32(3)
The Computer Systems Validation Process
35(8)
System Development Files
40(3)
Validation Project Plans and Schedules
43(6)
Regulatory Guidance
43(1)
Validation Project Plans
43(2)
Mandatory Signatures
45(1)
Project Schedule
45(4)
Inspections and Testing
49(8)
Regulatory Guidance
49(1)
Introduction
49(1)
Document Inspections and Technical Reviews
50(1)
White Box Testing
51(1)
Black Box Testing
52(2)
Other Testing Types
54(3)
Qualifications
57(24)
Introduction
57(1)
Hardware Installation Qualification
58(3)
Software Installation Qualification
61(3)
System Operational Qualification
64(3)
System Performance Qualification
67(2)
Operating System and Utility Software Installation Verification
69(1)
Standard Instruments, Microcontrollers, Smart Instrumentation Verification
70(3)
Standard Software Packages Qualification
73(1)
A Related Product for ISO/IEC 12119, The IEEE Standard Adoption of ISO/IEC 12119
73(3)
Configurable Software Qualification
76(2)
Custom-Built Systems Qualification
78(3)
SLC Documentation
81(4)
Regulatory Guidance
81(1)
SLC Documentation
81(4)
Relevant Procedural Controls
85(2)
Change Management
87(4)
Introduction
87(1)
Change Management Process
88(3)
Training
91(2)
Regulatory Guidance
91(1)
Training in the Regulated Industry
91(2)
Security
93(12)
Regulatory Guidance
93(1)
Introduction
93(3)
Physical Security
96(1)
Network Security
97(1)
Applications Security
98(1)
Other Key Security Elements
99(6)
Source Code
105(2)
Regulatory Guidance
105(1)
Introduction
105(2)
Hardware/Software Suppliers Qualification
107(4)
Maintaining the State of Validation
111(6)
Security
111(6)
Part 11 Remediation Project
117(4)
Introduction
117(1)
Evaluation of Systems
118(1)
Corrective Action Planning
119(1)
Remediation
119(1)
Remediation Project Report
120(1)
Operational Checks
121(4)
Instructions to Operators
121(1)
Operation Sequencing
121(1)
Part 11-Related Operational Checks
122(2)
Validation of Operational Checks
124(1)
Compliance Policy Guide (CPG) 7153.17
125(4)
Introduction
125(4)
Electronic Records
129(8)
Regulatory Guidance
129(1)
What Constitutes an Electronic Record?
129(1)
What Constitutes a Part 11 Required Record?
130(1)
How Should Part 11 Records Be Managed?
130(1)
Minimum Record Retention Requirements
131(1)
When Are Audit Trails Applicable for Electronic Records?
131(1)
Instructions
132(1)
Events
132(1)
Reviews
133(1)
Preservation Strategies
133(1)
Electronic Records Authenticity
134(1)
Storage
135(2)
Electronic Signatures
137(4)
Regulatory Guideline
137(1)
General Concepts
137(1)
Password-Based Signatures
138(1)
Digital Signatures
138(3)
Technologies Supporting Part 11
141(6)
Paper-Based versus Electronic-Based Solutions
141(1)
Hash Algorithms
142(1)
Data Encryption
142(3)
Digital Signatures
145(1)
Windows® OS
145(2)
All Together
147(6)
Acquisition Process
147(1)
Supply Process
148(1)
Development Process
148(2)
Operation Process
150(1)
Maintenance Process
150(3)
The Future
153(88)
Appendices
A Glossary of Terms
157(8)
B Abbreviations and Acronyms
165(2)
C Applicability of a Computer Validation Model
167(6)
D Criticality and Complexity Assessment
173(10)
E Sample Development Activities Grouped by Project Periods
183(26)
F Administrative Procedures Mapped to Part 11
209(6)
G Sample Audit Checklist for a Closed System
215(4)
H Computer Systems Regulatory Requirements
219(20)
I Technical Design Key Practices
239(2)
Index 241


López, Orlando