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Compliance & Quality

Commitment to Regulatory Standards

Our data management processes are built to meet or exceed all relevant regulatory requirements, including FDA 21 CFR Part 11, ICH GCP, and GDPR. We maintain comprehensive audit trails, enforce system access controls, and ensure traceability at every step. LabConnect’s Data Management team members are lab data experts, the majority coming from a lab tech background. We understand the lab process end to end. This expertise allows our lab data management to go above and beyond competitors who are data management generalists. Work with us and appreciate the difference!

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Our Compliance and Quality Capabilities

We focus on building robust processes that support reliable data, safeguard patient safety, and meet the expectations of sponsors and regulators. Our commitment is reflected in every step, from initial planning through ongoing review and improvement.

  • By Design: Quality control reviews before go-live
  • Standard Operating Procedures: Continuous improvement of SOPs
  • Data Integrity: Automated edit checks, real-time validation, audit-ready
  • Data Security: Robust encryption​
  • Ongoing Quality Enhancement: Feedback, metrics, and audit findings

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