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

Connect with our Quality team

Send us an email to schedule your visit by filling out the form below:

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