Data Integrity in Pharmaceutical and Medical Devices Regulation Operations
portes grátis
Data Integrity in Pharmaceutical and Medical Devices Regulation Operations
Best Practices Guide to Electronic Records Compliance
Lopez, Orlando
Taylor & Francis Ltd
07/2022
396
Mole
Inglês
9781032339887
15 a 20 dias
671
Descrição não disponível.
Preface. Introduction. Inspection Trends. Electronic Records Life Cycle. MHRA Definitions. Electronic Records Governance. Relevant Electronic Records Management Procedural Controls. Electronic Records Controls - Supporting Processes. Electronic Records Controls - In Storage. Electronic Records Controls - During Processing. Electronic Records Controls - While in Transit. Trustworthy Computer Systems. Electronic Records and Service Providers. Relevant Worldwide GMP Regulations and Guidelines. MHRA Guidance. Electronic Records Management - 21 CFR Part 211. Electronic Records Management - EMA Annex 11. Self Inspection. Summary. Appendices: Glossary of Terms. Abbreviations and Acronyms. Regulatory Cross Match. MHRA GMP Data Integrity Definitions and Guidance for Industry March 2015. Relevant Worldwide GCP and GLP Regulations and Guidelines. Electronic Records Integrity in Non-Clinical Laboratories. Electronic Records Integrity in Clinical Systems. Electronic Integrity in a Data Warehouse and Business Intelligence.
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
E-records Integrity;CFR;Data integrity;Rules Governing Medicinal Products;Electronic records integrity;Electronic records management - EMA Annex 11;Cop;21 CFR Part 211;Computerized Drug Processing;Worldwide GMP regulatins and guidelines;Audit Trails;Computer Infrastructure;Ich;Trustworthy Computer Systems;Pharmaceutical Inspection Co-operation Scheme;Ich Q7;Os;EU Guideline;NIST Handbook;Computer Systems Validation;Cloud Service Provider;E-records Migration;European Union Volume;CPG;GMP Organization;Current Good Manufacturing Practice;Healthcare Products Regulatory Agency;DHI;Technical Report Series
Preface. Introduction. Inspection Trends. Electronic Records Life Cycle. MHRA Definitions. Electronic Records Governance. Relevant Electronic Records Management Procedural Controls. Electronic Records Controls - Supporting Processes. Electronic Records Controls - In Storage. Electronic Records Controls - During Processing. Electronic Records Controls - While in Transit. Trustworthy Computer Systems. Electronic Records and Service Providers. Relevant Worldwide GMP Regulations and Guidelines. MHRA Guidance. Electronic Records Management - 21 CFR Part 211. Electronic Records Management - EMA Annex 11. Self Inspection. Summary. Appendices: Glossary of Terms. Abbreviations and Acronyms. Regulatory Cross Match. MHRA GMP Data Integrity Definitions and Guidance for Industry March 2015. Relevant Worldwide GCP and GLP Regulations and Guidelines. Electronic Records Integrity in Non-Clinical Laboratories. Electronic Records Integrity in Clinical Systems. Electronic Integrity in a Data Warehouse and Business Intelligence.
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
E-records Integrity;CFR;Data integrity;Rules Governing Medicinal Products;Electronic records integrity;Electronic records management - EMA Annex 11;Cop;21 CFR Part 211;Computerized Drug Processing;Worldwide GMP regulatins and guidelines;Audit Trails;Computer Infrastructure;Ich;Trustworthy Computer Systems;Pharmaceutical Inspection Co-operation Scheme;Ich Q7;Os;EU Guideline;NIST Handbook;Computer Systems Validation;Cloud Service Provider;E-records Migration;European Union Volume;CPG;GMP Organization;Current Good Manufacturing Practice;Healthcare Products Regulatory Agency;DHI;Technical Report Series
