Index of /04_Methodologie_Missions/Meth_Audit

[ICO]NameLast modifiedSizeDescription
[PARENTDIR]Parent Directory  -  
[ ]VSI_21CFR-Part11_Appendix3_SystemAssmentChecklist.docx2026-07-31 20:08 45K 
[ ]VSI_21CFR-Part11_Appendix2_TypesOfControlsRequired.docx2026-07-31 20:08 43K 
[IMG]Puce_new.gif2026-07-31 20:08 717  
[ ]Preparing_for_the_Audit_-_IT_Best_Practices.pdf2026-07-31 20:08 1.4M 
[DIR]Obsoletes/2026-07-31 20:08 -  
[ ]Monenviron.afw2026-07-31 20:08 243  
[TXT]Meth_Audits_Organisationnels.htm2026-07-31 20:08 3.9K 
[DIR]MV/2026-07-31 20:08 -  
[IMG]Logo_ISO.png2026-07-31 20:08 1.0K 
[IMG]Logo_FDA.png2026-07-31 20:08 909  
[IMG]Flag_World.gif2026-07-31 20:08 1.0K 
[IMG]Flag_WORLD.png2026-07-31 20:08 910  
[IMG]Flag_France12x12.gif2026-07-31 20:08 856  
[IMG]Flag_FR.png2026-07-31 20:08 144  
[IMG]Flag_Angleterre.gif2026-07-31 20:08 205  
[ ]EDL_RGPD_Rapport_FR.docx2026-07-31 20:08 282K 
[DIR]CLarevoir/2026-07-31 20:08 -  
[ ]CL_Interview_investigateur_HN.docx2026-07-31 20:08 27K 
[ ]CL_Docs_Audit_HN.docx2026-07-31 20:08 25K 
[ ]CL_Audit_Systeme.docx2026-07-31 20:08 35K 
[TXT]CAPA_Suivi.htm2026-07-31 20:08 1.3K 
[ ]A_rapport_plan_actions_TFr.docx2026-07-31 20:07 58K 
[ ]A_fiche_patient.xlsx2026-07-31 20:06 40K 
[ ]A___Report.docm2026-07-31 20:08 107K 
[ ]A__Staff_CL_En_Complement.docm2026-07-31 20:08 63K 
[ ]A__Staff_CL_En.docm2026-07-31 20:08 67K 
[ ]A__QMS_CL_En.docm2026-07-31 20:08 76K 
[ ]A__DM_CL_En.docx2026-07-31 20:08 114K 
[ ]A_Vigilance_Essais_Cliniques_Sponsor_CL_En.docx2026-07-31 20:07 119K 
[ ]A_Vigilance_Essais_Cliniques_CRO_CL_En.docx2026-07-31 20:07 121K 
[ ]A_VSI_TF_listeCV.docx2026-07-31 20:08 38K 
[ ]A_VSI_Questionnaire_En.docx2026-07-31 20:07 85K 
[ ]A_VSI_Inventory_of_computerized_systems.docx2026-07-31 20:07 38K 
[ ]A_VSI_IT_CL.docx2026-07-31 20:07 46K 
[ ]A_VSI_DSV_TF.docx2026-07-31 20:07 75K 
[ ]A_VSI_Checklist_Generale_v4.docx2026-07-31 20:07 49K 
[ ]A_VSI_Check_list_Audit_MARION.xls2026-07-31 20:07 373K 
[ ]A_VSI_CL_F.docx2026-07-31 20:07 145K 
[ ]A_VSI_CL_En_Cpl.docx2026-07-31 20:07 43K 
[ ]A_VSI_CL_En.docx2026-07-31 20:07 368K 
[ ]A_VSI_CL_EN_Editeur.docx2026-07-31 20:07 82K 
[TXT]A_VSI_CL.htm2026-07-31 20:07 24K 
[ ]A_VSI_Agenda_Fr.docx2026-07-31 20:07 49K 
[ ]A_VSI_Agenda_En.docx2026-07-31 20:07 51K 
[TXT]A_VSI.htm2026-07-31 20:07 6.6K 
[ ]A_VM_Prestataire_CL_LEEM.docx2026-07-31 20:07 72K 
[ ]A_VM_F_20080515.docx2026-07-31 20:07 49K 
[ ]A_VM_F.docx2026-07-31 20:07 49K 
[ ]A_Transporteur_CL_LEEM2026-07-31 20:07 56K 
[ ]A_Translation_CL_EN.docx2026-07-31 20:07 94K 
[ ]A_TRANSL_Agenda_Fr.docx2026-07-31 20:07 52K 
[ ]A_Systeme_Presentation_Resultats.pptx2026-07-31 20:07 71K 
[ ]A_Systeme_CL_Fr_GM_20160913.docx2026-07-31 20:07 58K 
[ ]A_Systeme_CL_Fr.docx2026-07-31 20:07 76K 
[ ]A_Systeme_Agenda_F.docx2026-07-31 20:07 43K 
[ ]A_Systeme_Agenda_E_BAK.docx2026-07-31 20:07 42K 
[ ]A_Systeme_Agenda_E.docx2026-07-31 20:07 47K 
[ ]A_SystemeCRO_Rapport_F.docx2026-07-31 20:07 72K 
[ ]A_System_CL_En_GM_2.docx2026-07-31 20:07 87K 
[ ]A_System_CL_En_GM.docx2026-07-31 20:07 113K 
[ ]A_System_CL_En.docx.BAK2026-07-31 20:07 183K 
[ ]A_System_CL_En.docx2026-07-31 20:07 75K 
[ ]A_Statistiques_CL_FR.docx2026-07-31 20:07 112K 
[ ]A_Statistiques_CL_En_Running.docx2026-07-31 20:07 85K 
[ ]A_Statistiques_CL_En.docx2026-07-31 20:07 119K 
[ ]A_ServiceProvider_PreliminaryQuestionnaire_vierge.pdf2026-07-31 20:07 1.0M 
[ ]A_ServiceProvider_PreliminaryQuestionnaire_Template2026-01.pdf2026-07-31 20:07 1.0M 
[ ]A_ServiceProvider_PreliminaryQuestionnaire_E.docx2026-07-31 20:07 59K 
[ ]A_Security_CL_En.docx2026-07-31 20:07 77K 
[ ]A_Securite_CL_F.docx2026-07-31 20:07 124K 
[ ]A_SYSTEME_CL_GM.docx2026-07-31 20:07 47K 
[ ]A_SNDS_CL_Fr.docx2026-07-31 20:07 1.0M 
[ ]A_SNDS_CL_FR.xlsx2026-07-31 20:07 11K 
[ ]A_Resultats_Presentation.pptx2026-07-31 20:07 53K 
[ ]A_Recueil_documents.docx2026-07-31 20:07 34K 
[ ]A_Rapport_plan_actions_TEn.docx2026-07-31 20:07 63K 
[ ]A_RapportEC__Report_En.docx2026-07-31 20:07 113K 
[ ]A_RapportEC_Rapport_Fr.docx2026-07-31 20:07 144K 
[ ]A_Randomisation_IWRS_CL_Fr.docx2026-07-31 20:07 138K 
[ ]A_RGPD_Global_CL.docx2026-07-31 20:07 91K 
[ ]A_Processus_Representation.pptx2026-07-31 20:07 67K 
[ ]A_Processus_InterviewTrame.docx2026-07-31 20:07 22K 
[ ]A_Prestataire_QuestionnairePrealable.docx2026-07-31 20:07 51K 
[ ]A_Prestataire_Fr.docx2026-07-31 20:07 95K 
[ ]A_Preclinic_GLP_study_Interview_Study_Director_TF.docx2026-07-31 20:07 38K 
[ ]A_PhaseI_CL_Fr.docx2026-07-31 20:07 118K 
[ ]A_PhaseI_CL_En.docx2026-07-31 20:07 94K 
[ ]A_Pharmacovigilance_Revue_cas_form.docx2026-07-31 20:07 39K 
[ ]A_Pharmacovigilance_Resultats_Presentation.pptx2026-07-31 20:07 76K 
[ ]A_Pharmacovigilance_CL_Fr.docx2026-07-31 20:07 262K 
[ ]A_Pharmacovigilance_CL_En.docx2026-07-31 20:07 178K 
[ ]A_PV_Tableau_Procedures_Fr.docx2026-07-31 20:07 41K 
[ ]A_PV_Tableau_Procedures_En.docx2026-07-31 20:07 40K 
[ ]A_PV_System_Distributor_Report_En.docx2026-07-31 20:07 66K 
[ ]A_PV_System_Distributor_CL_En.docx2026-07-31 20:07 104K 
[ ]A_PV_System_Corporate_CL_En.docx2026-07-31 20:07 123K 
[ ]A_PV_System_Corporate_Agenda_En.docx2026-07-31 20:07 55K 
[ ]A_PV_System_CSO_Report_En.docx2026-07-31 20:07 68K 
[ ]A_PV_System_CSO_CL_En.docx2026-07-31 20:07 86K 
[ ]A_PV_System_Affiliate_CL_En.docx2026-07-31 20:07 105K 
[ ]A_PV_Revue_cas_form_Clinical_Trials.docx2026-07-31 20:07 38K 
[ ]A_PV_Questionnaire_MaisonMere.docx2026-07-31 20:07 48K 
[ ]A_PV_Questionnaire_Filiale.docx2026-07-31 20:07 115K 
[ ]A_PV_Questionnaire_Distributeur_Bilingue.docx2026-07-31 20:07 49K 
[ ]A_PV_Plan_En.docx2026-07-31 20:07 39K 
[ ]A_PV_Personnel_File_Review_Form.docx2026-07-31 20:07 46K 
[ ]A_PV_PSUR_CL_Fr.docx2026-07-31 20:07 38K 
[ ]A_PV_Mandate_En.docx2026-07-31 20:07 39K 
[ ]A_PV_Mandat_Fr.docx2026-07-31 20:07 39K 
[ ]A_PV_Distributor_Preliminary_Questionnaire_En.docx2026-07-31 20:07 44K 
[ ]A_PV_Distributor_Agenda_En.docx2026-07-31 20:07 47K 
[ ]A_PV_Confirmation_LFr.docx2026-07-31 20:07 38K 
[ ]A_PV_Confirmation_LEn.docx2026-07-31 20:07 46K 
[ ]A_PV_CSO_Questionnaire_En.docx2026-07-31 20:07 45K 
[ ]A_PV_Agenda_Fr.docx2026-07-31 20:07 48K 
[ ]A_PV_Agenda_En.docx2026-07-31 20:07 48K 
[ ]A_PV-IM_Provider_Preliminary_Questionnaire.docx2026-07-31 20:07 39K 
[ ]A_Ouverture_Cloture_presence.docx2026-07-31 20:06 50K 
[ ]A_Organisationnel_CL_Fr.docx2026-07-31 20:06 76K 
[ ]A_Organisationnel_CL_FR_2.docx2026-07-31 20:06 40K 
[ ]A_Organisationnel_Agenda_Fr.docx2026-07-31 20:06 59K 
[ ]A_Opening_meeting.docx2026-07-31 20:06 40K 
[ ]A_Monitoring.docx2026-07-31 20:06 53K 
[ ]A_Materiovigilance_CL_Fr.docx2026-07-31 20:06 134K 
[ ]A_MR006_Rapport_Fr.docx2026-07-31 20:06 141K 
[ ]A_MR006_Etudes.xlsx2026-07-31 20:06 12K 
[ ]A_MR006_Agenda.docx2026-07-31 20:06 54K 
[ ]A_MR006.xlsx2026-07-31 20:06 12K 
[ ]A_MR001_MR003_Rapport_Fr.docx2026-07-31 20:06 89K 
[ ]A_MR001_MR003_Agenda_Fr.docx2026-07-31 20:06 56K 
[ ]A_LAB_Laboratoire_Fr.docx2026-07-31 20:06 130K 
[ ]A_LAB_Central_Lab_En.docx2026-07-31 20:06 201K 
[ ]A_LAB_Central_Lab_CL_En_PF-a-tester.docx2026-07-31 20:06 224K 
[ ]A_LAB_BioAnalytic_GCLP_En.docx2026-07-31 20:06 106K 
[ ]A_LAB_BioAnalytic_En_AIntegrer.docx2026-07-31 20:06 145K 
[ ]A_LAB_BioAnalysis_Validation_method_En.docx2026-07-31 20:06 212K 
[ ]A_LAB_BioAnalysis_Validation_Fr_AIntegrer.docx2026-07-31 20:06 65K 
[ ]A_LAB_Agenda_Fr.docx2026-07-31 20:06 49K 
[ ]A_LAB_Agenda_En.docx2026-07-31 20:06 58K 
[ ]A_InfoMed_Revue_cas.docx2026-07-31 20:06 67K 
[ ]A_InfoMed_CL_Fr.docx2026-07-31 20:06 63K 
[ ]A_InfoMed_CL_En.docx2026-07-31 20:06 79K 
[ ]A_ISO_13485_2016_DM_SMQ_CL.docx2026-07-31 20:06 86K 
[ ]A_ISO_9001_Agenda.docx2026-07-31 20:06 47K 
[ ]A_ISO_9001_2015_Report_Short_Version.docx2026-07-31 20:06 78K 
[ ]A_ISO_9001_2015_Report_Etat_Lieux.docx2026-07-31 20:06 72K 
[ ]A_ISO_9001_2015_Report.docx2026-07-31 20:06 97K 
[ ]A_ISO_9001_2015_Gap_CL_FR.docx2026-07-31 20:06 63K 
[ ]A_ISO_9001_2015_CL_Fr.docx2026-07-31 20:06 204K 
[ ]A_ISO_9001_2015_CL_EN.docx2026-07-31 20:06 66K 
[ ]A_ISO_9001_2015_Audit_Agenda_EN.docx2026-07-31 20:06 48K 
[ ]A_ISO_9001_2015_Audit_Agenda.docx2026-07-31 20:06 44K 
[ ]A_ISO_9001_2008_CL_En.docx2026-07-31 20:06 91K 
[ ]A_IMP_Stockage_CL.docx2026-07-31 20:06 22K 
[ ]A_IMP_Sponsor_CL_En.docx2026-07-31 20:06 64K 
[ ]A_IMP_Promoteur_CL_Fr.docx2026-07-31 20:06 76K 
[ ]A_IMP_Packaging_Shipment_CL.docx2026-07-31 20:06 70K 
[ ]A_IMP_Fabrication_CL_Fr.docx2026-07-31 20:06 387K 
[ ]A_IMP_Fabrication_CL.docx2026-07-31 20:06 41K 
[ ]A_IMP_Conditionnement_Distribution_CL_Fr.docx2026-07-31 20:06 147K 
[ ]A_IMP_Conditionnement_Distribution_CL_EN_BAK_20220622.docx2026-07-31 20:06 130K 
[ ]A_IMP_Conditionnement_Distribution_CL_EN.docx2026-07-31 20:06 186K 
[ ]A_IDMC_CL_En.docx2026-07-31 20:06 81K 
[ ]A_GDPR_CL_En.docx2026-07-31 20:06 63K 
[ ]A_Formation_VM_CL_Fr.docx2026-07-31 20:06 55K 
[ ]A_F_ThankYou_LEn.docx2026-07-31 20:06 37K 
[ ]A_F_Remerciements_LFr.docx2026-07-31 20:06 37K 
[ ]A_F_Observation_En.docx2026-07-31 20:06 36K 
[ ]A_F_Mandate_En.docx2026-07-31 20:06 47K 
[ ]A_F_Mandat_Fr.docx2026-07-31 20:06 39K 
[ ]A_F_FicheDeRemarque.docx2026-07-31 20:06 35K 
[ ]A_F_Consultation.docx2026-07-31 20:06 38K 
[ ]A_F_Confirmation_LFr.docx2026-07-31 20:06 37K 
[ ]A_F_Confirmation_LEn.docx2026-07-31 20:06 37K 
[ ]A_F_Certificate_En.docx2026-07-31 20:06 58K 
[ ]A_F_Certificat_Fr.docx2026-07-31 20:06 44K 
[ ]A_F_Agenda_Fr.docx2026-07-31 20:06 45K 
[ ]A_F_Agenda_En.docx2026-07-31 20:06 46K 
[ ]A_F_Accord_Confid_LFr.docx2026-07-31 20:06 36K 
[ ]A_EC_TMF_Report_En.docx2026-07-31 20:06 138K 
[ ]A_EC_TMF_Rapport_Fr.docx2026-07-31 20:06 116K 
[ ]A_EC_TMF_CL_FR_ISO_14155_copy.docx2026-07-31 20:06 47K 
[ ]A_EC_TMF_CL_FR_ISO_14155.docx2026-07-31 20:06 48K 
[ ]A_EC_TMF_CL_FR.docx2026-07-31 20:06 40K 
[ ]A_EC_TMF_Agenda_FR.docx2026-07-31 20:06 41K 
[ ]A_EC_TMF_Agenda_En.docx2026-07-31 20:06 42K 
[ ]A_EC_Sponsor_Agenda_En.docx2026-07-31 20:06 44K 
[ ]A_EC_Site_inv_CL_Test.docx2026-07-31 20:06 46K 
[ ]A_EC_Site_SAE_followup_CL_En.docx2026-07-31 20:06 40K 
[ ]A_EC_Site_Reunion_Prepa.docx2026-07-31 20:06 34K 
[ ]A_EC_Site_Report_RxPh_En.docx2026-07-31 20:06 105K 
[ ]A_EC_Site_Report_En_AIntegrer.docx2026-07-31 20:06 114K 
[ ]A_EC_Site_Report_En.docx2026-07-31 20:06 111K 
[ ]A_EC_Site_Rapport_Fr_DocFormation.docx2026-07-31 20:06 81K 
[ ]A_EC_Site_Rapport_Fr.docx2026-07-31 20:06 120K 
[ ]A_EC_Site_Rapport_FR_OK.docx2026-07-31 20:06 120K 
[ ]A_EC_Site_PlanAction_Fr.docx2026-07-31 20:06 45K 
[ ]A_EC_Site_PlanAction_En.docx2026-07-31 20:06 60K 
[ ]A_EC_Site_PlanAction_202309.docx2026-07-31 20:06 68K 
[ ]A_EC_Site_Patient_CL_En.docx2026-07-31 20:06 40K 
[ ]A_EC_Site_Patient_CL.docx2026-07-31 20:06 37K 
[ ]A_EC_Site_Interview_investigateur_TF.docx2026-07-31 20:06 48K 
[ ]A_EC_Site_Interview_investigateur_EN.docx2026-07-31 20:06 61K 
[ ]A_EC_Site_File_CL_En.docx2026-07-31 20:06 47K 
[ ]A_EC_Site_File_CL_EN2.docx2026-07-31 20:06 53K 
[ ]A_EC_Site_Dossier_CL_Fr.docx2026-07-31 20:06 58K 
[ ]A_EC_Site_Dispensing_IMP_CL_En.docx2026-07-31 20:06 40K 
[ ]A_EC_Site_Dispensation_IMP_CL_Fr.docx2026-07-31 20:06 43K 
[ ]A_EC_Site_Delegation_Responsibilites_CL_En_AmQ.docx2026-07-31 20:06 40K 
[ ]A_EC_Site_Delegation_Responsibilites_CL_En.docx2026-07-31 20:06 38K 
[ ]A_EC_Site_Consent_CL_Fr.docx2026-07-31 20:06 42K 
[ ]A_EC_Site_Consent_CL_En.docx2026-07-31 20:06 46K 
[ ]A_EC_Site_Confirmation_Fr.docx2026-07-31 20:06 40K 
[ ]A_EC_Site_Confirmation_En_BACK_20230228.docx2026-07-31 20:06 24K 
[ ]A_EC_Site_Confirmation_En.docx2026-07-31 20:06 25K 
[ ]A_EC_Site_Agenda_En.docx2026-07-31 20:05 46K 
[ ]A_EC_Safety_CL_EN.docx2026-07-31 20:05 88K 
[ ]A_EC_Regulatory_Steps_CL_EN.docx2026-07-31 20:05 77K 
[ ]A_EC_RedactionMedicale_CL.docx2026-07-31 20:05 83K 
[ ]A_EC_Project_Management_CL_EN.docx2026-07-31 20:05 54K 
[ ]A_EC_NonInterventionnel_Documentation_CL.docx2026-07-31 20:05 53K 
[ ]A_EC_NonInterventionnel_CL_FR.docx2026-07-31 20:05 92K 
[ ]A_EC_Monitoring_CL_EN.docx2026-07-31 20:05 46K 
[ ]A_EC_Monitoring_CL.docx2026-07-31 20:05 55K 
[ ]A_EC_Medical_Writing_CL_En.docx2026-07-31 20:05 61K 
[ ]A_EC_CSR_Plan_En.docx2026-07-31 20:05 46K 
[ ]A_EC_CSO_Agenda_En.docx2026-07-31 20:05 47K 
[ ]A_EC_CMO_Agenda_En.docx2026-07-31 20:05 44K 
[ ]A_EC_Agenda_Fr.docx2026-07-31 20:05 56K 
[ ]A_Data_Protection_CL.docx2026-07-31 20:05 87K 
[ ]A_Data_Integrity_Flow_Review_En.docx2026-07-31 20:05 36K 
[ ]A_Data_Integrity_CL_En.docx2026-07-31 20:05 57K 
[ ]A_Data_Integrity_Assessment_Grid_En.docx2026-07-31 20:05 45K 
[ ]A_DataManagement_FollowUp_CL_En_BACKUP-PJ.docx2026-07-31 20:05 132K 
[ ]A_DataManagement_FollowUp_CL_En.docx2026-07-31 20:05 161K 
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[ ]A_DM_SMQ_ISO_13485_2016_CL_En.docx2026-07-31 20:05 98K 
[ ]A_DM_SMQ_ISO_13485_2016_CL.docx2026-07-31 20:05 86K 
[ ]A_Cosmetovigilance_CL_Fr.docx2026-07-31 20:05 92K 
[ ]A_CentralReading_CL_En.docx2026-07-31 20:05 87K 
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[ ]A_CRO_referencement_Novartis.docx2026-07-31 20:05 95K 
[ ]A_CRO_RTU_CL.docx2026-07-31 20:05 96K 
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[ ]A_CRO_ATU_CL.docx2026-07-31 20:05 94K 
[ ]A_CEC_CL_En.docx2026-07-31 20:05 78K 
[ ]A_Biometrie_Agenda_F.docx2026-07-31 20:05 49K 
[ ]A_Biometrie_Agenda_E.docx2026-07-31 20:05 53K 
[ ]A_Biobank_CRB_CL_Fr.docx2026-07-31 20:05 67K 
[ ]A_Biobank_CRB_CL_EN.docx2026-07-31 20:05 96K 
[ ]A_BdD_Rapport_En.docx2026-07-31 20:05 88K 
[ ]A_BdD_Rapport.docx2026-07-31 20:05 64K 
[ ]A_BdD_Formulaire.docx2026-07-31 20:05 38K 
[ ]A_BdD_Form_discrepancies.xlsx2026-07-31 20:05 42K 
[ ]A_BdD_Agenda_Fr.docx2026-07-31 20:05 46K 
[ ]A_BdD_Agenda_En.docx2026-07-31 20:05 42K 
[ ]A_BPL_Animal_En.docx2026-07-31 20:05 156K 
[ ]A_BPL_Animal_Agenda_En.docx2026-07-31 20:05 50K 
[ ]A_Audit_debriefing.pptx2026-07-31 20:05 533K 
[ ]A_Audit_Closeout_letter.docx2026-07-31 20:05 42K 
[ ]A_Attendee_List_FR.docx2026-07-31 20:05 30K 
[ ]A_Attendee_List.docx2026-07-31 20:05 28K 
[ ]A_Astreinte_sous_traitee_CL_Fr.docx2026-07-31 20:05 53K 
[ ]A_Astreinte_sous-traitee_CL_En.docx2026-07-31 20:05 76K 
[ ]A_Archiving_CL_FR.docx2026-07-31 20:05 116K 
[ ]A_Archiving_Agenda_FR.docx2026-07-31 20:05 52K 
[ ]A_Archivage_Referentiel_F_BAK.docx2026-07-31 20:05 74K 
[ ]A_Archivage_Referentiel_F_BAK.doc2026-07-31 20:05 240K 
[ ]A_Archivage_Locaux_CL_BAK.doc2026-07-31 20:05 167K 
[ ]A_Affaires_Reglementaires_CL.docx2026-07-31 20:05 139K 
[ ]A_AQ_CLFr.docx2026-07-31 20:05 39K 
[ ]A_AQ_CL.docx2026-07-31 20:05 59K 
[ ]0__Cheklist_Audit_Jeanne_RENARD.pptx2026-07-31 20:05 296K 
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