Quality & Safety

ZAS Quality Standards

The ZAS Quality Management team meticulously implements stringent, standardized quality control measures by prioritizing seamless compliance and highest quality – for every archiving good, from pick up to retrieval.

• Service level compliance from the moment of handover till the agreed end point
• Validated software, qualified equipment
  Seamless track and trace from pickup to return
• Audit trail
• Continuous, standardized quality control measures
• Standardized processes for regulatory compliance
• Quality trained staff

Certifications:

• GLP, Good Laboratory Practice
• GMP, Good Manufacturing Practice
• Manufacturing authorization (§13 AMG)
• DIN EN ISO 9001
• ISO/IEC 27001
• DIN ISO 50001

Compliant processes according to:

• ICH GCP Guideline
• DAKKS DIN EN ISO 20387

Permissions:

• §49 German Infection Protection Act (Infektionsschutzgesetz, IfSG), Safety Level S2
• Animal Disease Pathogen Regulation (Tierseuchenerregerverordnung, TierSeuchenerV), Safety Level T2
• Genetic Engineering Act (Gentechniksicherheitsverordnung, GenTSV), Safety Level S2
• Biological Agents Regulation (Biostoffverordnung, BioStoffV), Safety Level S2

IT System validity:

• validated eQMS
• validated archive systems (TELESTO)
• GAMP-5 validated software
• qualified on premise IT hardware

ZAS Safety Standards

Whether you archive your biosamples, retentions samples, e-data or documents with us, the standardized and uniform ZAS Safety Standards guarantee ongoing security from pick up to return.

• Data security: Validated archiving software, daily full backups, cyber security training, data hosting in own geo-redundant data center located in Germany
• CO2 fire protection in selected areas
• 24/7 guarded premises: video, fences, alarm, guard service
• 24/7 surveilled archives and systems: access control, pest control
• Restricted access
• Consistent risk management: Disaster Recovery and Business Continuity Management plans
• Site Master File
• Climate control: Temperature and humidity monitoring, emergency power supply, redundant freezers, automatic N2 refilling
• Integrated Pest Monitoring (IPM)
• Consistency controls