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E-raamat: Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation

  • Formaat: 344 pages
  • Ilmumisaeg: 02-Oct-2018
  • Kirjastus: CRC Press
  • Keel: eng
  • ISBN-13: 9781351704359
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Pharmaceutical and Medical Devices Manufacturing Computer Systems ValidationSuurem pilt
  • Formaat: 344 pages
  • Ilmumisaeg: 02-Oct-2018
  • Kirjastus: CRC Press
  • Keel: eng
  • ISBN-13: 9781351704359
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Validation of computer systems is the process that assures the formal assessment and report of quality and performance measures for all the life-cycle stages of software and system development, its implementation, qualification and acceptance, operation, modification, requalification, maintenance and retirement (PICS CSV PI 011-3). It is a process that demonstrates the compliance of computer systems functional and non-functional requirements, data integrity, regulated company procedures and safety requirements, industry standards, and applicable regulatory authority’s requirements. Compliance is a state of being in adherence to application-related standards or conventions or regulations in laws and similar prescriptions.This book, which is relevant to the pharmaceutical and medical devices regulated operations, provides practical information to assist in the computer validation to production systems, while highlighting and efficiently integrating worldwide regulation into the subject. A practical approach is presented to increase efficiency and to ensure that the validation of computer systems is correctly achieved.
Preface xv
1 Introduction 1(4)
2 What Is a Computer Systems Validation (CSV)? 5(10)
SIPOCs
8(2)
When Are Computer Systems Validated?
10(1)
Sample Related Regulations/Guidance
10(1)
Core Principles
11(2)
Additional Readings
13(2)
3 CGMP Regulatory Requirements for Production Computer Systems 15(22)
Introduction
15(1)
Expectations by Key Regulatory Authorities
16(10)
Australia
16(1)
Brazil
17(1)
Canada
17(1)
China
18(1)
Europe
18(2)
Japan
20(1)
United Kingdom
21(1)
United States
21(5)
CGMP Applicability to Hardware and Software
21(1)
21 CFR Part 211.68
22(4)
Expectation by Worldwide Entities
26(6)
ICH Q7
26(3)
ICH Q9
29(1)
OMCL Network of the Council of Europe
30(1)
PIC/S
31(1)
WHO
31(1)
E-Records Integrity
32(1)
Final Note
32(3)
Core Principle
35(1)
Additional Reading
35(2)
4 Maxims in CSV 37(4)
Business Requirements
37(1)
Objective Evidence
38(1)
Intended Use
38(1)
Proper Performance
39(1)
Operating Environment
39(2)
5 General CSV Principles 41(8)
Core Principle
41(1)
Principle 1
41(1)
Principle 2
42(1)
Principle 3
42(1)
Principle 4
43(1)
Principle 5
43(1)
Principle 6
44(1)
Principle 7
44(1)
Principle 8
45(2)
Principle 9
47(1)
Principle 10
47(2)
6 System Life Cycle 49(6)
Introduction
49(1)
The System Life Cycle
50(2)
Applicable Quality Principles to the SLC
52(1)
Life Cycle Principles
53(1)
Sample Related Regulations/Guidance/Standards
54(1)
Core Principle
54(1)
Additional Readings
54(1)
7 SLC Documentation 55(8)
Types of Documents
56(2)
Specifications
56(1)
Plans
56(1)
Protocols
57(1)
SOPs
58(1)
Reports
58(1)
Typical Documentation for the Acquisition Process
58(2)
ASTM E 2500-13
60(1)
Test Scripts and Test Results
60(1)
Worst Case Conditions
60(1)
Confirmation of Consistent Functionality
61(1)
Core Principle
61(1)
Additional Reading
62(1)
8 Management of the Computer System Requirements 63(18)
Introduction
63(3)
Requirements Management
66(1)
Obtaining an Understanding of Requirements
67(1)
Obtaining Commitment to Requirements
68(2)
Managing Requirements Changes
70(3)
Maintaining Bidirectional Traceability of Requirements
73(2)
Ensuring Alignment Between Project Work and Requirements
75(3)
Summary
78(1)
Tools
78(1)
Core Principle
79(1)
Additional Readings
79(2)
9 Risk Based Validation 81(10)
Introduction
81(1)
Risk Assessment in Computer Validation, Where Does It Apply?
82(2)
Risk Management
84(2)
Risk Analysis
85(1)
Risk Mitigation
86(1)
Risk Evaluation and Assessment
86(1)
Integration Risk Management with SLC
86(1)
Conceptualization
87(1)
Development
87(1)
Operational Life
87(1)
Retirement
87(1)
Tools
87(1)
Core Principles
88(1)
Regulatory Requirements/Guidance
88(1)
SIPOC (Figure 9.2)
89(1)
Additional Readings
89(2)
10 CSV Plans and Schedules 91(6)
CSV Plans
91(3)
Project Schedule
94(3)
11 Project Management, SLC, Production CSV, ITIL 97(6)
Introduction
97(1)
Alignment-New Technology/Service Life Cycle
98(1)
Alignment-Service Deployment
99(3)
Additional Readings
102(1)
12 Computer Systems Operational Life 103(8)
Introduction
103(1)
Operational Life
104(1)
Operation Activities
105(3)
Maintenance Activities
108(1)
Summary
109(1)
Core Principle
109(2)
13 Suppliers and Service Providers 111(6)
Acquisition Process
115(1)
Supply Process
115(1)
Additional Readings
115(2)
14 Trustworthy Computer Systems 117(18)
Introduction to Trustworthy Computer Systems
118(1)
Computer Systems Suited to Performing Their Intended Functions
119(4)
ISO 9000-3
121(1)
US FDA
121(1)
World Health Organization (WHO)
122(1)
Japanese MHLW
122(1)
Brazil ANVISA
123(1)
Provide a Reasonably Reliable Level of Availability, Reliability and Correct Operation
123(3)
ISO 9000-3
124(1)
US FDA
125(1)
EU and TGA
125(1)
PIC/S PI-011-3, ASEAN and Canadian HPFBI
125(1)
ICH
125(1)
WHO
126(1)
China SFDA
126(1)
Brazil ANVISA
126(1)
Secure from Intrusion and Misuse
126(3)
ISO 9000-3
127(1)
US FDA
127(1)
EU, TGA and China SFDA
128(1)
PIC/S PI-011-3, ASEAN and Canadian HPFBI
128(1)
ICH
128(1)
WHO
129(1)
Brazil ANVISA
129(1)
Adhere to Generally Accepted Security Principles
129(2)
Trustworthy Computer Systems Infrastructure
131(2)
Computer System Procedures
133(1)
Summary
133(1)
Additional Readings
134(1)
15 Control of Data and Records 135(6)
Introduction
135(1)
Control of Data
136(2)
Control of Records
138(2)
Core Principle
140(1)
Additional Reading
140(1)
16 Technologies Supporting Integrity of E-Records 141(22)
Introduction
141(3)
Cryptographic Technologies
144(6)
Cryptographic Technologies Applicable to E-Records Integrity
150(1)
E-Records at Rest
151(7)
Access Controls and Authority Checks to Computer Resources
152(1)
Audit Trails Controls
153(1)
Authentication
154(1)
Security of the Electronic Signatures
155(1)
Signature E-Records Linkage
156(1)
Time Controls
157(1)
Uniqueness of the Electronic Signatures
158(1)
E-Records in Transit
158(2)
Integrity of E-Records in Transit
158(2)
Device Checks
160(1)
Summary
160(1)
Core Principle
161(1)
Disclaimer
162(1)
Additional Readings
162(1)
17 Infrastructure Qualification Overview 163(8)
What Is Infrastructure?
163(2)
What Is Infrastructure Qualification?
165(1)
Why Do We Qualify Computer Infrastructure?
166(1)
Introduction to the Infrastructure Qualification Process
167(2)
All Together
169(2)
18 Remediation Projects 171(10)
Introduction
171(1)
Evaluate Systems
172(1)
Corrective Action Planning
173(1)
Remediation
174(2)
Interpretation
174(1)
Training
175(1)
Remediation Execution
175(1)
New Applications and Application Upgrade Assessments
175(1)
Suppliers Qualification Program
176(1)
Remediation Project Report
176(1)
Special Case-Retrospective Evaluation
176(2)
Essentials Retrospective Evaluation Management
178(1)
Core Principles
179(1)
Regulatory Requirements/Guidance
179(1)
SIPOC (Figure 18.2)
180(1)
19 Production CSV Program Organization 181(8)
Organizational Model
181(1)
CSV Executive Committee
181(1)
CSV Cross-Functional Team
182(2)
Computer Systems Validation Groups and Teams
184(1)
Management Group
185(1)
Validation Program Coordinators
185(4)
20 Integration Between Computer System and E-Records Life Cycles 189(12)
Introduction
189(1)
Development Period
190(6)
Computer Systems Validation
190(1)
Requirements
191(2)
Risk Assessment
193(2)
E-records Migration and Computer Systems Release to Operations
195(1)
Operations
196(4)
Computer System Retirement-E-Records Migration
197(1)
E-Records Archiving
197(2)
E-Records Destruction
199(1)
Additional Readings
200(1)
21 Digital Date and Time Stamps 201(6)
Introduction
201(1)
System Clock
201(1)
Computer Clock Reliability
202(1)
Digital Time-Stamping Service
203(1)
Time Zone
204(1)
Computer Systems Not Networked
204(1)
Computer Clock Controls
204(1)
Additional Readings
205(2)
22 New Technologies and Critical Processes 207(16)
Access Management
207(4)
Big Data
211(2)
Cloud Environments
213(3)
Internet of Things
216(1)
Service Level Agreements
217(1)
Reference
218(1)
Wireless
218(5)
WLAN Devices
219(1)
Access Point
219(1)
VPN Server
220(1)
LAN Switch
220(1)
WLAN System Qualification
220(1)
Data Integrity in Wireless Environments
221(2)
23 All Together 223(6)
Acquisition Process
224(1)
Supply Process
225(2)
Development Process
227(1)
Operation Process
227(1)
Maintenance Process
227(1)
Core Principle
227(2)
Appendix I: Glossary of Terms 229(34)
Appendix II: Abbreviations and/or Acronyms 263(4)
Appendix III: Regulatory Cross Match 267(22)
Appendix IV: Additional Readings 289(6)
Appendix V: Reference Papers on E-Records Integrity 295(2)
Appendix VI: Case Study-Cloud-Based SCADA 297(18)
Index 315
Orlando López



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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