Quality & Safety
Prioritizing seamless quality and 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
- 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:
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
