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Quality Systems: CLIA/CAP Readiness for Bioinformatics Labs | QMS, Validation & CAPA

NTHRYS >> Services >> Academic Services >> Training Programs >> Bioinformatics Training >> Clinical & Translational Bioinformatics / Precision Medicine >> Quality Systems: CLIA/CAP Readiness for Bioinformatics Labs | QMS, Validation & CAPA

Quality Systems: CLIA/CAP Readiness for Bioinformatics Labs — Hands-on

Build a pragmatic, audit-proof Quality Management System (QMS) for clinical bioinformatics. This module translates CLIA/CAP expectations into day-to-day workflows across validation/verification, documentation, data integrity (ALCOA+) , training & competency, supplier qualification, change control, internal audits, and CAPA—so your pipelines and reports can withstand inspections.

Quality Systems: CLIA/CAP Readiness for Bioinformatics Labs
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Session 1
Fee: Rs 23120
QMS & CAP/CLIA Foundations
  • Quality system architecture
  • policy → SOP → WI → forms roles & responsibilities quality manual
  • CAP checklist mapping (high-level)
  • bioinformatics-specific items pre-analytical → post-analytical risk-based priorities
  • CLIA applicability (overview)
  • LDTs & reporting personnel & supervision proficiency testing
Session 2
Fee: Rs 27320
Validation/Verification & Data Integrity
  • Method validation & verification
  • accuracy/precision/LoD/LoQ linearity/reportable range reference materials & QC
  • Bioinformatics pipeline V&V
  • truth sets/coverage change impact analysis re-validation triggers
  • ALCOA+ data integrity
  • attributable/legible/contemporaneous original/accurate/complete consistent/enduring/available
Session 3
Fee: Rs 31520
Documentation, Training & Change Control
  • Doc control & templates
  • SOP/WI/forms/versioning traceability & records electronic signatures
  • Training & competency
  • matrices & curricula assessments/attestations continuing education
  • Change control & suppliers
  • software/hardware changes vendor qualification service level oversight
Session 4
Fee: Rs 37120
Internal Audits, CAPA & Inspection Readiness
  • Internal audit program
  • plans/checklists objective evidence reports & follow-ups
  • Deviations, incidents & CAPA
  • root-cause analysis effectiveness checks trend reviews
  • Inspection readiness
  • war room & SME prep mock inspections continuous improvement


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