Kosten durch fehlerhafte Laborqualität (Re‑Tests und Studienwiederholungen)

Definition

GLP frameworks in Australia, as implemented through NATA recognition and TGA GLP compliance certification, require laboratories to maintain high standards for the conduct of experiments, documentation of raw data, and archiving of records.[1][2][5][3][7] Poorly managed quality control—such as missed calibrations, incomplete raw‑data capture, or deviations from SOPs—can render study results scientifically unreliable or non‑defensible, meaning the data cannot be used in regulatory submissions.[1][2][5][7] Consulting and certification guides describe GLP as a system of management controls that ensures consistency, reliability, and integrity of non‑clinical safety tests, specifically to avoid ineffective research, further testing, or investigating what went wrong.[2] When GLP is not properly embedded, the consequence is avoidable rework: repeating in‑vitro assays, re‑running animal studies, or extending stability and analytical testing. Industry practice shows that a single complex non‑clinical assay series commonly costs tens of thousands of AUD, and full GLP study reruns can reach hundreds of thousands. Therefore, even a modest rate of quality‑driven repeats (e.g., 5–10% of key GLP activities) can easily waste AUD 50,000–500,000 per year in an active biotech research organisation in Australia.

Why This Matters

The Pitch: Biotechnology research players in Australia 🇦🇺 waste AUD 50,000–500,000 per year on repeat assays and re‑run GLP studies caused by preventable quality control errors. Automation of QC checks, instrument validation tracking, and electronic lab records reduces these repeat‑work costs substantially.

Affected Stakeholders

Quality Control Manager, Study Director, Laboratory Manager, R&D Scientists, Project Finance Controller

Related Business Risks