Enrico Mangahis
Visit Investigator ProfileInvestigation Details
Detailed Analysis
Enrico Mangahis employs a methodical approach, thoroughly examining documentation and records to ensure strict adherence to validated processes. He prioritizes the identification and management of deviations and puts significant emphasis on data integrity and security.
Enrico Mangahis is highly focused on ensuring stringent adherence to validated procedures and proper documentation. He is meticulous in verifying compliance with QA review and approval processes, as well as ensuring that deviations are identified and managed effectively. His observations reflect a strong emphasis on the importance of validated ranges, proper record-keeping, and security of data access. He appears to have a low tolerance for repeated non-compliance, particularly related to product reviews and validation protocols.
- Material Storage and Control
- Process Monitoring
- Data Integrity
- Deviations
- Batch Records
Unlock Insights from 483s & Stay Audit Ready with FDA Tracker
Monitor FDA Six Systems, Analyse 483s with Observations, Investigators & Companies