{"id":512,"date":"2022-08-04T15:49:55","date_gmt":"2022-08-04T13:49:55","guid":{"rendered":"https:\/\/www.qstep.it\/servizi\/computerized-system-validation\/"},"modified":"2023-05-05T19:12:34","modified_gmt":"2023-05-05T17:12:34","slug":"computerized-system-validation","status":"publish","type":"page","link":"https:\/\/www.qstep.it\/en\/servizi\/computerized-system-validation\/","title":{"rendered":"Computerized system validation"},"content":{"rendered":"\n

COMPUTERIZED SYSTEM VALIDATION

LEGGI DI PI\u00d9

La nostra esperienza nella convalida \u00e8 forte di una approfondita conoscenza dei processi GxP e dei relativi sistemi quali:

IT Business Systems (e.g., ERP, LIMS, MES),
Pharmacovigilance Systems (e.g. ARGUS,AERS, SafetyDrugs, Veeva Safety)
Laboratory Systems (CDMS, HPLC, GC,HPLC, GC, UV VIS, Difrattometro, Bilance, Microbiological equipment)

Manufacturing Systems (e.g PLC, SCADA, Equipment, eBRS, Dispensing Systems)
Clinical Applications (e.g. Oracle Clinical, DataTrak One, Veeva Vauld CDMS, Veeva eTMF, Custom eCRF)

I nostri servizi in ambito CSV coprono tutte le fasi del ciclo di vita di un sistema:

\"\"



Definizione Policy and SOPs sui processi di computer system validation
Vendors Selection and Qualification
Computer System Validation Strategy
GxP Risk Assessment
Process Mapping & definizione User Requirements
Revisione documentazione tecnica dei fornitori
Design Review
Test strategy definition and execution
Validation Reporting
Data Migration Strategy and Execution
Change Management
Periodic Compliance Review
Business Continuity & Disaster Recovery
Computer Inspection Readiness Support
Infrastructure Qualification
Decommission Planning and Reporting
Data Archiving

\"spirale-servizio-1\"

\"frecce\"

<\/p>\n","protected":false},"excerpt":{"rendered":"

COMPUTERIZED SYSTEM VALIDATION LEGGI DI PI\u00d9 La nostra esperienza nella convalida \u00e8 forte di una approfondita conoscenza dei processi GxP e dei relativi sistemi quali: IT [\u2026]<\/span><\/p>\n","protected":false},"author":1,"featured_media":457,"parent":510,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-512","page","type-page","status-publish","has-post-thumbnail","hentry"],"yoast_head":"\nComputerized system validation - QStep<\/title>\n<meta name=\"description\" content=\"Sosteniamo le aziende in tutti gli step relativi alla computerized system validation, dalla definizione del business case all'operativit\u00e0.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.qstep.it\/en\/servizi\/computerized-system-validation\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Computerized system validation - 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