Muutke küpsiste eelistusi

E-raamat: EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP

  • Formaat: 379 pages
  • Ilmumisaeg: 06-Apr-2015
  • Kirjastus: CRC Press Inc
  • Keel: eng
  • ISBN-13: 9781482243635
Teised raamatud teemal:
  • Formaat - PDF+DRM
  • Hind: 273,00 €*
  • * hind on lõplik, st. muud allahindlused enam ei rakendu
  • Lisa ostukorvi
  • Lisa soovinimekirja
  • See e-raamat on mõeldud ainult isiklikuks kasutamiseks. E-raamatuid ei saa tagastada.
  • Raamatukogudele
EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMPSuurem pilt
  • Formaat: 379 pages
  • Ilmumisaeg: 06-Apr-2015
  • Kirjastus: CRC Press Inc
  • Keel: eng
  • ISBN-13: 9781482243635
Teised raamatud teemal:

DRM piirangud

  • Kopeerimine (copy/paste):

    ei ole lubatud

  • Printimine:

    ei ole lubatud

  • Kasutamine:

    Digitaalõiguste kaitse (DRM)
    Kirjastus on väljastanud selle e-raamatu krüpteeritud kujul, mis tähendab, et selle lugemiseks peate installeerima spetsiaalse tarkvara. Samuti peate looma endale  Adobe ID Rohkem infot siin. E-raamatut saab lugeda 1 kasutaja ning alla laadida kuni 6'de seadmesse (kõik autoriseeritud sama Adobe ID-ga).

    Vajalik tarkvara
    Mobiilsetes seadmetes (telefon või tahvelarvuti) lugemiseks peate installeerima selle tasuta rakenduse: PocketBook Reader (iOS / Android)

    PC või Mac seadmes lugemiseks peate installima Adobe Digital Editionsi (Seeon tasuta rakendus spetsiaalselt e-raamatute lugemiseks. Seda ei tohi segamini ajada Adober Reader'iga, mis tõenäoliselt on juba teie arvutisse installeeritud )

    Seda e-raamatut ei saa lugeda Amazon Kindle's. 

Good Manufacturing Practice (GMP) ensures medicinal products are produced consistently and controlled to the quality standards appropriate for their intended use and as required by product specifications or marketing authorization. Annex 11 details the European Medicines Agency (EMA) GMP requirements for computer systems.

The purpose of Annex 11 is to provide the EMA healthcare industry with consistent criteria for effective implementation, control, and use of computer systems.EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP supplies practical information to facilitate compliance with computer system GMP requirements, while highlighting and integrating the Annex 11 guidelines into the computer compliance program.

The ideas presented in this book are based on the author’s 25 years of experience with computer validation in the healthcare industry with various computer systems development, maintenance, and quality functions. The bookdetails a practical approach to increase efficiency and to ensure that software development and maintenance are achieved correctly.

Examining the implementation of the computer systems validation entirely based on EU Annex 11, the book includes examples from laboratory, clinical, and manufacturing computer systems. It also discusses electronic record integrity associated with stored information.

Preface xv
Author xix
Contributors xxi
1 Introduction 1(6)
References
5(2)
2 SLC, Computer Validation, and Annex 11 7(6)
Life-Cycle Principles
11(1)
References
11(2)
3 Annex 11 Principles 13(6)
Analysis
13(4)
Principle 1
13(2)
Principle 2
15(2)
Principle 3
17(1)
References
17(2)
4 Risk Management 19(10)
EU Annex 11-1, General
19(1)
Related References
19(1)
Analysis
20(2)
Risk Assessment
22(3)
Risk Mitigation
25(1)
Risk Evaluation
25(1)
Risk Monitoring and Control
26(1)
Approach
27(1)
Summary
28(1)
References
28(1)
5 Personnel 29(4)
EU Annex 11-2, General
29(1)
Analysis
29(1)
References
30(3)
6 Suppliers and Service Providers 33(6)
EU Annex 11-3, General
33(1)
Analysis
34(4)
Acquisition Process
37(1)
Supply Process
37(1)
References
38(1)
7 Validation 39(12)
EU Annex 11-4, Project Phase
39(1)
Analysis
40(5)
Primary Life-Cycle Processes
45(3)
Acquisition Process
46(1)
Supply Process
46(1)
Development Process
47(1)
Operation and Maintenance Processes
48(1)
References
48(3)
8 Data 51(10)
R.D. McDowall
EU GMP Annex 11-5, Operational Phase
51(1)
Introduction
51(1)
Impact of Other Sections of Annex 11
51(2)
Preserving the Content and Meaning of Data
53(1)
Some Data Transfer Options
54(1)
Manually Driven Electronic File Transfers
55(1)
Copy and Paste/Drag and Drop Electronic Transfers
55(1)
Ensuring Data Integrity
56(1)
Automatic Methods of Electronic Data Transfer
57(1)
Data Migration Issues
57(1)
Validation Considerations for Data Transfer
58(1)
Reference
59(2)
9 Accuracy Checks 61(4)
EU Annex 11-6, Operational Phase
61(1)
Analysis
61(1)
Accuracy Checks Performed by Computer Systems
62(2)
References
64(1)
10 Data Storage 65(6)
EU Annex 11-7-Operational Phase
65(1)
Analysis
65(1)
Inputs and Outputs
66(1)
Storage
66(2)
Retention
68(1)
Relevant Controls
68(1)
References
69(2)
11 Printouts 71(4)
EU Annex 11-8, Operational Phase
71(1)
Analysis
71(4)
12 Audit Trails-Ensuring Data Integrity 75(8)
R.D. McDowall
EU GMP Annex 11-9, Operational Phase
75(1)
Introduction
75(1)
Relationship of Clause 9 to Other Sections in EU GMP
76(1)
Chapter 4: Documentation Essentials
76(1)
Security Section Clause 12.4
77(1)
Annex 11 Audit Trail Requirements
78(3)
Additional Audit Trail Requirements
81(1)
References
81(2)
13 Change and Configuration Management 83(8)
EU Annex 11-10, Operational Phase
83(1)
Other References
83(1)
Analysis
83(3)
Types of Maintenance
86(1)
Data Migration
87(1)
Retirement (If Applicable)
88(1)
References
89(2)
14 Periodic Evaluation: Independent Review to Ensure Continued Validation of Computerized Systems 91(20)
R.D. McDowall
EU Annex 11-11, Operational Phase
91(1)
Analysis
91(2)
Overview of a Periodic Review
93(1)
Objectives of a Periodic Review
93(2)
Reviewer Skills and Training
95(1)
How Critical Is Your System?
96(1)
When to Perform a Review?
97(1)
Types of Periodic Review
98(1)
Writing the Periodic Review Plan
99(1)
Preparation for a Periodic Review
100(1)
Activities during the Periodic Review
101(2)
Who Is Involved and What Do They Do?
103(1)
Review of the Last System Validation
104(2)
Reviewing Requirements: Role of Traceability
106(1)
Other Areas for Review
106(1)
Operational Review
106(1)
IT Department Involvement
107(1)
Reviewer's Closed Meeting
107(1)
Observations, Findings, and Recommendations
108(1)
Closing Meeting
108(2)
Documenting the Periodic Review
110(1)
References
110(1)
15 Security 111(10)
EU Annex 11-12, Operational Phase
111(1)
Related References
111(1)
Analysis
112(1)
Physical Security
113(1)
Network Security
114(2)
Applications Security
116(2)
Database Security/Integrity
118(1)
References
119(2)
16 Incident Management 121(6)
EU Annex 11-13, Operational Phase
121(1)
Analysis
121(2)
Process Equipment-Related Malfunction
123(1)
Software/Infrastructure Component Malfunction
123(1)
Incorrect Documentation or Improper Operation
124(1)
Emergency Incidents
124(1)
References
124(3)
17 Electronic Signatures: Electronic Signing Requirements 127(8)
R.D. McDowall
EU GMP Annex 11-14, Operational Phase
127(1)
Introduction
127(2)
Interpretation of Annex 11 Electronic Signature Regulations
129(3)
Impact of Annex 11 Electronic Signature Requirements on Software Design
132(1)
References
133(2)
18 Batch Certification and Release 135(10)
Bernd Renger
EU Annex 11-15, Operational Phase
135(1)
Related References
135(1)
Introduction
136(1)
Legal and Regulatory Background
136(1)
The Qualified Person
136(1)
Certification, Confirmation, and Certificates
137(1)
IT Systems and QP Certification/Confirmation
138(2)
The QP Relying on the Pharmaceutical Quality System
140(3)
Control of Batch Release
143(2)
19 Business Continuity 145(4)
EU Annex 11-16-Operational Phase
145(1)
Introduction
145(1)
Analysis
146(1)
Business Continuity Plan
147(1)
References
148(1)
20 Archiving 149(4)
EU Annex 11-17-Operational Phase
149(1)
Analysis
149(1)
Method of Archival
150(1)
Retirement
151(1)
References
151(2)
21 SLC Documentation 153(10)
Related References
153(1)
Analysis
153(7)
Summary
160(1)
References
160(3)
22 Relevant Procedural Controls 163(4)
Introduction
163(3)
Reference
166(1)
23 Maintaining the Validated State in Computer Systems 167(8)
Introduction
167(1)
Operational Life
168(1)
Operational Activities
169(3)
Maintenance Activities
172(1)
Summary
173(1)
References
173(2)
24 Annex 11 and the Cloud 175(32)
R.D. McDowall
Yves Samson
Overview of the
Chapter
175(1)
EU GMP Annex 11
176(2)
Legal Requirements
178(2)
Data Privacy
178(1)
Intellectual Property
179(1)
Physical Location of the Server
180(1)
Summary of GXP and Legal Requirements
180(1)
What Is Cloud Computing?
180(1)
Customer Requirements for Cloud Computing
181(1)
Cloud Service Models
182(1)
Cloud Services Delivery Modes
183(1)
Managing and Mitigating Regulatory Risk
183(1)
SaaS Service Cloud Options
183(3)
Single or Multi-Tenant Options
184(2)
Requirements for Compliant IT Infrastructure
186(1)
IT Infrastructure Elements
187(2)
Service Providers: Requirements for Audits and Agreements
189(1)
Auditing a Cloud Provider
190(1)
Audit Objectives
191(1)
What Are We Auditing Against?
191(1)
Does ISO 27001 Certification Provide Compliance with GXP Regulations?
191(4)
Methods of Auditing a Supplier
195(3)
Questionnaire
195(1)
Questionnaire Plus Follow-Up
196(1)
Questionnaire Plus On-Site Audit
196(2)
How to Select an IT Service Provider
198(4)
Stage 1: Review Provider Websites
198(1)
Stage 2: Remote Assessment of the Quality Management System (QMS)
199(1)
Stage 3: On-Site Audit of the Service Provider
200(2)
What Do We Need in an Agreement?
202(2)
Contract Management: How to Write a Contract
204(1)
Operation and Monitoring Phase
205(1)
References
205(2)
25 EU GMP
Chapter 4-Documentation and Annex 11		 207(22)
Markus Roemer
Introduction
207(3)
Overview EU GMP
Chapter 4 Documentation
210(1)
Documentation-Basic Setup and Requirements
211(3)
Paper versus Electronic Records
214(1)
What Is a Computerized System?
215(1)
What Is Software?
216(1)
What Is Data?
217(2)
Timelines and Life Cycles
219(2)
And Again Something about Audit Trails
221(2)
Quality of Decisions
223(2)
Data Rich-Information Poor (DRIP)
225(1)
GMP Datability
225(1)
Validation and Data Integrity
226(3)
26 Annex 11 and Electronic Records Integrity 229(24)
Introduction
229(2)
Data Integrity
231(10)
Annex 11 E-recs Integrity Basis
241(1)
Annex 11 E-recs Integrity Approach
242(3)
Conclusion
245(5)
References
250(3)
27 Annex 11 and 21 CFR Part 11: Comparisons for International Compliance 253(10)
Introduction
253(1)
Comparing the 11s
254(1)
Electronic Signatures
254(2)
11.50(a)(1) and (3); 11.50(b)
255(1)
11.100(c)(1) and (2)
255(1)
11.200(a)(1)(i) and (ii); 11.200(a)(3); 11.200(b)
255(1)
11.300
256(1)
Controls for Closed Systems
256(5)
Validation (11.10(a))
257(1)
The Ability to Generate Accurate, Complete Copies of Records (11.10(b))
258(1)
Protection of Records (11.10(c) and (d))
259(1)
Use of Computer-Generated, Time-Stamped Audit Trails
(11.10(e), (k)(2) and Associated Requirements in 11.30)
259(1)
Use of Appropriate Controls over Systems Documentation
260(1)
System Access Limited to Authorized Individuals (11.10(d), (g) and (h))
260(1)
Conclusion
261(1)
References
261(2)
Appendix A: EMA Annex 11, Rev 1992 263(4)
Appendix B: EMA Annex 11, Rev 2011 267(8)
Appendix C: Glossary of Terms 275(26)
Appendix D: Abbreviations and Acronyms 301(4)
Appendix E: Comparison between EU Annex 11 and US FDA-211, 820, 11; Other Guidelines and Regulations 305(22)
Appendix F: Case Study SCADA and Annex 11 327(14)
References 341(6)
Index 347
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.
Lisainfo e-raamatute kohta Lisainfo e-raamatute kohta
Püsilink: https://www.kriso.ee/db/97814822436352e.html
Märksõnad: