Invitation to Audit
GLP and cGMP compliant sequencing and data analysis for your regulatory submissions.
ACGT’s main offices and laboratories are located in the northwest suburbs of Chicago. A CLIA and CAP-accredited facility equipped
with the following to ensure data security and the integrity of our laboratory processes.
- Internally developed SOPs and policies implemented and monitored by an independent Quality Assurance (QA) team
- Strict accountability protocols including Chain of Custody from sample receipt to final analysis
- Instrument IQ/OQ/PQ Qualifications to ensure consistency and data reliability
- 24/7 video monitoring surveillance system
- Card-controlled access areas for trained staff only
- Data redundancy including daily backup and onsite and offsite data storage
- Change control program documented, reviewed and approved by QA team
- Out of Specification (OOS) and Out of Range (OOR) quality acceptance criteria and Corrective Action Preventative Action
(CAPA) plan to determine and resolve root causes - Backup power generators to protect against outages and maintain continuous temperature control
- Annual and quarterly internal audits performed by QA personnel
- Card-controlled access and fireproof cabinets for the archival of regulatory records