Laboratories

services-star

Reliable laboratory operations depend on consistent quality, validated processes, and regulatory compliance. GSAP helps laboratories establish robust quality systems, optimize operations, validate critical processes, and maintain ongoing readiness for inspections and accreditation.

Lab desk

How We Support Laboratories

 

  • Method Qualification & Validation
    Design of phase-appropriate qualification, validation, and technology transfer strategies for analytical methods, including bioanalytical, molecular, cell-based, chemical, microbiological, and diagnostic assays
  • Laboratory QMS & Compliance
    Establishment, improvement, and auditing of laboratory Quality Management Systems aligned with ISO 17025, ISO 15189, GLP, and GMP requirements
  • Sample & Reference Material Governance
    Development of sample management processes, chain-of-custody controls, reference material qualification programs, and stability management frameworks
  • OOS Investigations & Analytical Governance
    Implementation of procedures for Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations, root cause analysis (RCA), CAPA management, and analytical deviation handling
  • Instrument Qualification & Data Controls
    Oversight of analytical instrument qualification (IQ/OQ/PQ), laboratory data governance, audit trail controls, and computerized laboratory systems oversight