Personnel: Authorized after adequate and assessment
Equipments: Implement risk-based full lifecycle management, externally calibrated, 3Q confirmed, USB limited.
Software: Empower CDS, OpenLab CDS and other analysis software with audit trail, automatic sampling, implementation domain control, file deletion prevention, physical isolation from external network, advanced one-to-one account management system, authority classification to ensure data logic security, authenticity, reliability and traceability.
Disaster Recovery System: Global Advanced Backup System (VERITAS), with Server and stand-alone version for Full Backup + Incremental Backup + Remote Backup, all data stored for at least 8 years.
Power supply system: power failure alarm system with UPS power supply and power generation by generator, to ensure business continuity.
Environmental monitoring system: laboratory and refrigerator environment ensured with calibrated monitoring equipments, validated environmental conditions, automatic recording (10min/time) and automatic alarm.
Access control management system: different experimental areas with different access rights allocation, physical isolation, and security management.
Special Drug Management: The special drug room which has passed the acceptance of public security and safety supervision is managed according to the five principles of double acceptance, double custody, double receipt, double locks and double principal accounts, so as to ensure the legality and compliance of the use of special drugs.
Document management: independent archives, access control, project independent files, archives kept for at least 8 years.
LIMS system：Thermo Fisher SampleManager