| Description |
1 online resource (345 pages) |
| Contents |
Preface -- 1. Introduction -- 2. What Is a Computer Systems Validation (CSV)? -- 3. CGMP Regulatory Requirements for Production Computer Systems -- 4. Maxims in CSV -- 5. General CSV Principles -- 6. System Life Cycle -- 7. SLC Documentation -- 8. Management of the Computer System Requirements -- 9. Risk Based Validation -- 10. CSV Plans and Schedules -- 11. Project Management, SLC, Production CSV, ITIL -- 12. Computer Systems Operational Life -- 13. Suppliers and Service Providers -- 14. Trustworthy Computer Systems -- 15. Control of Data and Records -- 16. Technologies Supporting Integrity of E-Records -- 17. Infrastructure Qualification Overview -- 18. Remediation Projects -- 19. Production CSV Program Organization -- 20. Integration Between Computer System and E-Records Life Cycles -- 21. Digital Date and Time Stamps -- 22. New Technologies and Critical Processes -- 23. All Together -- Appendix I: Glossary of Terms -- Appendix II: Abbreviations and/or Acronyms -- Appendix III: Regulatory Cross Match -- Appendix IV: Additional Readings -- Appendix V: References PapersE-Records Integrity -- Appendix VI: Case StudyCloud-Based SCADA -- Index |
| Summary |
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 |
| Notes |
Print version record |
| Subject |
Medical instruments and apparatus -- Design
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Medical instruments and apparatus -- Quality control
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Pharmaceutical industry -- Data processing
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Equipment and Supplies
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Computer systems.
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Computer security.
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Pharmaceutical technology -- Methods
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Equipment and Supplies
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Computer Systems
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Computer Security
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Technology, Pharmaceutical -- methods
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MEDICAL -- Hospital Administration & Care.
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MEDICAL -- Pharmacology.
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Computer security
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Computer systems
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Equipment and supplies
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Medical instruments and apparatus -- Design
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Medical instruments and apparatus -- Quality control
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Pharmaceutical industry -- Data processing
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Pharmaceutical technology
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| Genre/Form |
Methods (Music)
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| Form |
Electronic book
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| ISBN |
9781351704359 |
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1351704354 |
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