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Mahboubeh Lotfinia profile page

Qualified Person and Quality Partner

Mahboubeh Lotfinia works as a Qualified Person and Quality Partner at F. Hoffmann-La Roche and is trained in GMP/GDP audit execution and CSV (Computerized System Validation).


Areas of Expertise

Computer System Validation
GMP/GDP

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Published Content
Total: 1
Person typing on a laptop with digital icons representing data analysis and audit trail processes.
Article

Audit Trail Requirements for a Digitalized Regulated Laboratory

This article discusses options for reviews, the regulatory requirements and guidance for audit trails, audit trail design, procedures for audit trail review and explains how to apply ALCOA++ principles for effective review of entries.
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