补充描述:
This consultancy covers project management with computer system validation and full documentation (GAMP 5, 21 CFR Part 11, Annex 11), spanning SAP and other ERP platforms, quality management, document management, stability management, artwork management, laboratory information management, training management, electronic archival and regulatory submission systems, vendor qualification workflows, PLC/SCADA evaluation, data integrity remediation, pharmacovigilance and clinical data management software, and regulatory information management systems, complemented by onsite and offsite training in quality management, computer system validation and data integrity.
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