{"product_id":"pharmaceutical-and-medical-devices-manufacturing-computer-systems-validation-9781138041189","title":"Pharmaceutical and Medical Devices Manufacturing","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003e\u003cp\u003eValidation 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.\u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e\u003cp\u003eThis 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 i\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTable of Contents\u003c\/b\u003e\u003cbr\u003e\u003c\/p\u003e\u003cp\u003e\u003cem\u003ePreface\u003c\/em\u003e\u003c\/p\u003e\u003cp\u003e1. Introduction\u003c\/p\u003e\u003cp\u003e2. What Is a Computer Systems Validation (CSV)?\u003c\/p\u003e\u003cp\u003e3. CGMP Regulatory Requirements for Production Computer Systems\u003c\/p\u003e\u003cp\u003e4. Maxims in CSV\u003c\/p\u003e\u003cp\u003e5. General CSV Principles\u003c\/p\u003e\u003cp\u003e6. System Life Cycle\u003c\/p\u003e\u003cp\u003e7. SLC Documentation\u003c\/p\u003e\u003cp\u003e8. Management of the Computer System Requirements\u003c\/p\u003e\u003cp\u003e9. Risk Based Validation\u003c\/p\u003e\u003cp\u003e10. CSV Plans and Schedules\u003c\/p\u003e\u003cp\u003e11. Project Management, SLC, Production CSV, ITIL\u003c\/p\u003e\u003cp\u003e12. Computer Systems Operational Life\u003c\/p\u003e\u003cp\u003e13. Suppliers and Service Providers\u003c\/p\u003e\u003cp\u003e14. Trustworthy Computer Systems\u003c\/p\u003e\u003cp\u003e15. Control of Data and Records\u003c\/p\u003e\u003cp\u003e16. Technologies Supporting Integrity of E-Records\u003c\/p\u003e\u003cp\u003e17. Infrastructure Qualification Overview\u003c\/p\u003e\u003cp\u003e18. Remediation Projects\u003c\/p\u003e\u003cp\u003e19. Production CSV Program Organization\u003c\/p\u003e\u003cp\u003e20. Integration Between Computer System and E-Records Life Cycles\u003c\/p\u003e\u003cp\u003e21. Digital Date and Time Stamps\u003c\/p\u003e\u003cp\u003e22. New Technologies and Critical Processes\u003c\/p\u003e\u003cp\u003e23. All Together\u003c\/p\u003e\u003cp\u003eAppendix I: Glossary of Terms\u003c\/p\u003e\u003cp\u003eAppendix II: Abbreviations and\/or Acronyms\u003c\/p\u003e\u003cp\u003eAppendix III: Regulatory Cross Match\u003c\/p\u003e\u003cp\u003eAppendix IV: Additional Readings\u003c\/p\u003e\u003cp\u003eAppendix V: References Papers—E-Records Integrity\u003c\/p\u003e\u003cp\u003eAppendix VI: Case Study—Cloud-Based SCADA\u003c\/p\u003e\u003cp\u003eIndex\u003c\/p\u003e","brand":"Taylor \u0026 Francis Ltd","offers":[{"title":"Default Title","offer_id":50577801150807,"sku":"9781138041189","price":128.25,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0817\/1739\/5799\/files\/9781138041189.jpg?v=1746096763","url":"https:\/\/bookcurl.com\/products\/pharmaceutical-and-medical-devices-manufacturing-computer-systems-validation-9781138041189","provider":"Book Curl","version":"1.0","type":"link"}