Built for regulated trials and proven for audit readiness

GLP/GCP‑aligned, GCLP‑style quality systems deliver reliable, submission‑ready data end‑to‑end in our purpose‑built Lenexa facility.

The standards we work to

  • GLP, GCP, and GCLP alignment. We operate under GLP/GCP and GCLP‑aligned quality frameworks, with independent QA oversight and documented processes built for regulatory review.

  • CLIA where applicable. Clinical testing in our network follows CLIA requirements, with additional state licensure as needed, supporting end‑to‑end clinical programs.

  • 21 CFR Part 11 and 58. Electronic records and signatures comply with 21 CFR Part 11; our bioanalytical quality systems are based on 21 CFR Part 58, with internal audits, e‑documentation, training, deviation and CAPA programs, and SOPs.

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Data integrity & traceability

  • ALCOA‑driven records. We maintain accountability and traceability through validated systems, documented controls, and QA review.

  • Chain of custody from receipt to result. Sample registration, labeling, storage/retrieval, and final disposition are fully traceable, preserving chain of custody across every hand‑off.

  • Facility designed for compliance. Our consolidated Lenexa facility was built to support regulated workflows and data integrity across modern clinical programs.

Method governance & validation

  • Defensible methods. Assays are developed, transferred, and validated per global guidance; our teams support fit‑for‑purpose validation with clear acceptance criteria and documentation.

  • Change control and CAPA. Formal deviation, change control, and CAPA programs ensure issues are captured, investigated, and closed with preventive actions.

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Electronic systems & documentation

  • Part 11‑compliant e‑systems. We manage training, documentation, and controlled records electronically to ensure version control and audit trails for all study‑critical activities.

  • Submission‑ready outputs. Reports and data packages are prepared to support inspections and regulatory submissions, streamlining sponsor pathways from Phase I to post‑market.

What clients and sponsors gain

  • Audit‑ready operations grounded in GLP/GCP and GCLP‑aligned practices.

  • Electronic, Part 11‑compliant records with end‑to‑end traceability.

  • Documented chain of custody across registration, storage, and final disposition.

  • Independent QA oversight with internal audits, deviation/CAPA, and SOP control.

  • Facility built for compliance and modern clinical trial demands.

  • Global process harmonization to support multi‑site, multi‑country trials.

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Blog article

Navigating the Maze: How Biopharma Trials Stay Compliant from Lab Bench to Regulatory Benchmarks

Discover how biopharma teams ensure compliance across preclinical and clinical stages through GLP, GCP, and GCLP standards.

Access now