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Software Package And Information Systems - Document Management System (Etmf And Eisf) For Clinical Studies. Uz Leuven Wishes To Use An Electronic Trial Master File (Etmf) And Investigator Site File (Eisf) System To Save, Manage And Archive Essential Documents Generated By Around 700 Clinical Studies Per Year (+/- 1,000 Unique Users). With Such A Digital Solution, Compliance With The Regulations And Readyness For Inspections, Significant Cost Savings In Relation To Paper Archiving, Efficiency Gain, Improved Overview By Sponsor/Researcher, Simplified Cooperation Between Different (Internal & External) Stakeholders, Effective Access Control To Documents, Reporting And General Reporting And General Reporting And General, Reporting And General, Reporting And General, Reporting And General, Reporting And Reportage, Reporting And General Reporting, Reporting And Reporting, Reporting And General Reporting, Reporting And Reporting, Reporting And Reporting, Reporting And General Reporting, Reporting And Reporting, Reporting And Reporting, Report And Reporting, Report And Reporting, Report And Reporting, Report And Report, Reporting And Report, Reporting And Reporting, Reporting And Reporting, Reporting And Reporting, Reporting And Reporting, Reporting And Report, Report, And Reporting, Reporting, Reporting And Report, Report, And Report, Report, And Report. The Structure Of The Etmf/Eisf Must Follow The Internationally Recognized (Dia) Tmf Reference Model. The Etmf/Eisf System Must Comply With The Applicable Regulations And Industrial Standards For Clinical Examination, Including But Not Limited To: - Eu 2016/679: General Data Protection Regulation (Gdpr) - Ema/Ins/Gcp/112288/2023: Ema -Guideline On Computerized Systems And Electronic Data -Data Sanco/C8/Am/Ares (2010) 1064599: Eu Rules Governing Medicinal Products In The European Union - Volume 4: Good Manufacturing Practice (Gmp) For Medicinal Products For Human And Veterinary Use - Annex 11: Fda 21 Cfrotatics - Fdas 21 Cfrosics) Iso/Iec 27018: 2019 Certification: Information Technology - Security Techniques - Code Of Practice For Protection Of Personally Identifiable Information (Pii) In Public Clouds Acting As Pii Processors - Iso/Iec 27001: 2022 Privacy - Management - Information - Management - Management - Management - Management - Management - Management - Management - Management - Management - Management - Management - Management - Management - Management - Management - Management - Management - Management Security: Information Security: Information Security, Management, Management Security: Information Security, Manbersecifercuritur, Manbersecifiition: Information Security: Information Security: Information Security: Security Security: Information Security: Information Security Systems - Requirements - Ich Good Clinical Practice (Gcp) E6
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