Quality

Our biorepository services can only be the best in the industry if our people are trained, certified, and fully understand what quality means.

The security and integrity of your research samples are the standard we use to judge ourselves. To ensure we’re doing all we can, we conduct quarterly internal audits of each of our global biorepositories. We also enlist independent auditors to evaluate our practices to ensure operating procedures are practically fail-proof – though we never take that fact for granted.

Whether we’re using a mobile biorepository to transport a lab or storing your samples until they’re needed, your success and satisfaction is our central goal.

Storing and managing samples to meet tomorrow’s standards

• Purpose-built biorepositories, stringent processes, and expert staff ensure sample integrity and compliance.
• Azenta maintains a commitment to quality with over 300 Standard Operating Procedures (SOPs).
• A full-time quality assurance team oversees procedures and monitors evolving regulations to keep us compliant with new standards. Formally scheduled, independent internal audits ensure our operating procedures are fail-proof. Clients and prospects are also invited to conduct their own audits of our facilities.

Biorepository Security and Data Protection

• Security – Azenta biorepository facilities are custom-designed and purpose-built for storing samples. Our facilities are auto-secured by card-controlled access areas that admit only trained staff.
• Surveillance – 24/7 video monitoring system and surveillance procedures protect each of our facilities.
• Heat, Smoke and Motion Detectors – Fast response times to security alerts are sent to smartphones of our facilities managers.
• Protected Data Infrastructure – Sample data is stored in an offsite, Category 5 Data Center prioritized for protection by the US government.
• Data Redundancy – All data is backed up daily. We mirror data storage on redundant servers located onsite at our biorepository and offsite at our secure data center.
• On-going monitoring – Performance monitors are in place to ensure equipment in use at customer sites is operating correctly. This monitoring allows Azenta Life Sciences to proactively service equipment before critical failures occur and negatively impact our clients.
• Change Control – All changes are documented and reviewed by the quality unit and executed using a risk-based approach. Customers will be notified of the planned changes as needed.

Business Continuity Plan

• Guaranteed 24-Hour Resources – Biorepository resupply for diesel fuel, liquid nitrogen, and dry ice ensures that our business essentials are readily available.
• Facility Backup Power – For Biorepositories, the facility backup generators activate within seconds of an outage. Power is transferred to maintain continuous temperature control and protect samples. All other sites have generators that can be activated as needed.
• Equipment Redundancy – Back-up generators are load-tested regularly for 30 minutes to ensure our facilities maintain continuous temperature control and stored samples maintain the highest integrity.

As a trusted partner for research advancements and product development, genomics services constantly strives to meet the needs and expectations of our customers. Our philosophy is to ensure that quality is built into all aspects of our regulatory services.

The Genomics Quality Management System follows Good Clinical Practices (GCP) guidelines and ensures GLP and CLIA compliance throughout our projects. Quality oversight confirms strict FDA and EPA regulatory adherence for our regulatory services customers and consistency in all of your data.

Quality by Design

• GLP and CLIA regulatory-compliant laboratory with adherence to GCP guidelines
• Regulatory compliance and SOP education
• Method and Assay Validation procedures
• Custom Study Protocol Preparation and Reporting for your specific project requirements
• Vendor Qualification Program ensures all vendors meet Quality System standards of excellence

Quality by Infrastructure

• Sample Handling and Tracking System: Controls sample check-in, processing, storage, and disposal
• Restricted-access GLP and CLIA compliant laboratory with adherence to GCP guidelines
• Instrument Qualification (IQ/OQ/PQ) Program for key equipment used for regulatory services
• On-site restricted access document archive with fireproof storage
• Electronic data back-up and storage

Quality by Assurance

• Corrective Action/Preventative Action (CAPA) System: Identification of problem, the root cause, and continuous improvements in quality
• Out of Specification (OOS) Investigation System: Investigation of any unexpected and/or abnormal results
• Quality Trending System: Identification of variations or trends in data
• Regular internal audits and management reviews
• Quality management is overseen by an independent quality assurance department