Neomed Labs Pacific Biomarkers PAIRimmune are now Nexelis
 

Quality Commitment

We are committed to world-class standards through robust scientific and data processes. Our processes are optimized to ensure we deliver results of utmost quality while maintaining sample and data integrity. Our well-established quality management system is supported by global accreditation and lab certifications.

Global Accreditations and Lab Certifications

Data Management

Sample Management

Global Accreditations and Lab Certifications

We maintain a well-defined quality management system aligned with regulatory requirements and client needs. The quality processes are designed to adhere to applicable GCP and GLP guidelines, ensuring compliance for our clients and for the studies we support. Our team is committed to quality through oversight, issue identification and resolution processes as well as initial and on-going training of staff. The QA department is fully independent in its oversight and ensures compliance through document control, internal audits, vendor audits, metrics, and other monitoring activities.

Equipment and computerized systems used to support client studies are fully validated as per required standards, including 21 CFR Part 11 compliance. Documentation is preserved in internal and external archives with restricted access to safeguard data and study materials throughout the retention period.

Current Accreditations/Certifications

Data Management

  • Management of clinical and non-clinical data
  • Data managed using validated, customized Laboratory Information Management System (LIMS)
  • Study sample testing managed within LIMS
  • Integrated project and data management – Positioned to meet study deliverables on, or ahead of time
  • Data transfer methods adapted based on client and regulatory requirements
  • Rigorous quality control processes to ensure data integrityprior to transfer
  • Flexibility in reporting other data types include QC data and sample inventory
  • Uncompromising dedication to protecting personal information

Sample Management

  • Validated Laboratory Information Management System (LIMS) maintained with a reliable audit trail
  • Customized solutions available in LIMS catering to client needs
  • Full traceability of sample chain of custody from receipt to destruction/shipmentprocedures
  • Established sample management to ensure compliance with regulatory requirements.
  • Adherence to International Air Transport Association (IATA) guidelines.
  • Confirmation of transportation requirements and verification of samples upon receipt.
  • Capacity for short- and long-term storage.
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